Ignite Creation Date:
2025-12-24 @ 8:02 PM
Ignite Modification Date:
2026-01-03 @ 10:30 AM
Study NCT ID:
NCT05647304
Status:
COMPLETED
Last Update Posted:
2025-03-10
First Post:
2022-11-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pilot Clinical Investigation Evaluating the Safety and Performance of RGn550 in Treating Sportspeople Suffering From Acute Concussion Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001924', 'term': 'Brain Concussion'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}], 'ancestors': [{'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}, {'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D016489', 'term': 'Head Injuries, Closed'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D014949', 'term': 'Wounds, Nonpenetrating'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'gblivet@regenlife.com', 'phone': '+33434481535', 'title': 'Guillaume Blivet', 'organization': 'REGEnLIFE'}, 'certainAgreement': {'otherDetails': 'If the investigators wish to publish data from this investigation (poster, abstract, article, etc.), they must first seek approval from REGEnLIFE.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Lack of sham group Single blinding Monocentric design'}}, 'adverseEventsModule': {'timeFrame': 'Throughout the investigation (from D0 to D52)', 'eventGroups': [{'id': 'EG000', 'title': '5 Hz-PWM', 'description': 'RGn550 with a 5 Hz-pulsed wave mode light emission\n\nRGn550 5 Hz-PWM: RGn550 with a 5 Hz-pulsed wave mode light emission', 'otherNumAtRisk': 26, 'deathsNumAtRisk': 26, 'otherNumAffected': 12, 'seriousNumAtRisk': 26, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '10 Hz-PWM', 'description': 'RGn550 with a 10 Hz-pulsed wave mode light emission\n\nRGn550 10 Hz-PWM: RGn550 with a 10 Hz-pulsed wave mode light emission', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 10, 'seriousNumAtRisk': 24, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Photophobia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Medical device site discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Medical device site warmth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Concussion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Ligament sprain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Hypersomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': "Incidence of RGn550's Adverse Device Effects (ADEs)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '5 Hz-PWM', 'description': 'RGn550 with a 5 Hz-pulsed wave mode light emission\n\nRGn550 5 Hz-PWM: RGn550 with a 5 Hz-pulsed wave mode light emission'}, {'id': 'OG001', 'title': '10 Hz-PWM', 'description': 'RGn550 with a 10 Hz-pulsed wave mode light emission\n\nRGn550 10 Hz-PWM: RGn550 with a 10 Hz-pulsed wave mode light emission'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Throughout the investigation (from Day 0 to Day 52)', 'description': 'Percentage of patients with at least one ADE', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients randomized and treated at least once (at inclusion visit)'}, {'type': 'SECONDARY', 'title': "Incidence of RGn550's ADEs Per Severity (Mild, Moderate and Severe)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '5 Hz-PWM', 'description': 'RGn550 with a 5 Hz-pulsed wave mode light emission\n\nRGn550 5 Hz-PWM: RGn550 with a 5 Hz-pulsed wave mode light emission'}, {'id': 'OG001', 'title': '10 Hz-PWM', 'description': 'RGn550 with a 10 Hz-pulsed wave mode light emission\n\nRGn550 10 Hz-PWM: RGn550 with a 10 Hz-pulsed wave mode light emission'}], 'classes': [{'title': 'Patients who had at least one mild ADE', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Patients who had at least one moderate ADE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Patients who had at least one severe ADE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Throughout the investigation (from Day 0 to Day 52)', 'description': 'Percentage of patients with at least one ADE per severity (mild, moderate and severe)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients randomized and treated at least once (at inclusion visit)'}, {'type': 'SECONDARY', 'title': "Incidence of RGn550's Adverse Events (AEs)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '5 Hz-PWM', 'description': 'RGn550 with a 5 Hz-pulsed wave mode light emission\n\nRGn550 5 Hz-PWM: RGn550 with a 5 Hz-pulsed wave mode light emission'}, {'id': 'OG001', 'title': '10 Hz-PWM', 'description': 'RGn550 with a 10 Hz-pulsed wave mode light emission\n\nRGn550 10 Hz-PWM: RGn550 with a 10 Hz-pulsed wave mode light emission'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Throughout the investigation (from Day 0 to Day 52)', 'description': 'Percentage of patients with at least one AE', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients randomized and treated at least once (at inclusion visit)'}, {'type': 'SECONDARY', 'title': "Incidence of RGn550's Device Deficiencies (DDs)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '5 Hz-PWM', 'description': 'RGn550 with a 5 Hz-pulsed wave mode light emission\n\nRGn550 5 Hz-PWM: RGn550 with a 5 Hz-pulsed wave mode light emission'}, {'id': 'OG001', 'title': '10 Hz-PWM', 'description': 'RGn550 with a 10 Hz-pulsed wave mode light emission\n\nRGn550 10 Hz-PWM: RGn550 with a 10 Hz-pulsed wave mode light emission'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Throughout the investigation (from Day 0 to Day 52)', 'description': 'Percentage of patients with at least one DD', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients randomized and treated at least once (at inclusion visit)'}, {'type': 'SECONDARY', 'title': 'Evolution of Automated Oculomotor and Oculopostural Functions, as Assessed Through the Convergence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '5 Hz-PWM', 'description': 'RGn550 with a 5 Hz-pulsed wave mode light emission\n\nRGn550 5 Hz-PWM: RGn550 with a 5 Hz-pulsed wave mode light emission'}, {'id': 'OG001', 'title': '10 Hz-PWM', 'description': 'RGn550 with a 10 Hz-pulsed wave mode light emission\n\nRGn550 10 Hz-PWM: RGn550 with a 10 Hz-pulsed wave mode light emission'}], 'classes': [{'title': 'D0 before treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.6', 'spread': '5.6', 'groupId': 'OG000'}, {'value': '2.9', 'spread': '3.1', 'groupId': 'OG001'}]}]}, {'title': 'D0 after treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.8', 'spread': '2.6', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '1.2', 'groupId': 'OG001'}]}]}, {'title': 'D7 before treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.3', 'spread': '2.1', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '0.8', 'groupId': 'OG001'}]}]}, {'title': 'D7 after treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.0', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.4', 'groupId': 'OG001'}]}]}, {'title': 'D52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.9', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '1.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'at Day 0 and Day 7 (before and after treatment session) and at Day 52', 'description': 'Evolution of the Near Point of Convergence (NPC)', 'unitOfMeasure': 'NPC (cm)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients randomized and treated at least once (at inclusion visit)'}, {'type': 'SECONDARY', 'title': 'Evolution of Automated Oculomotor and Oculopostural Functions, as Assessed Through Deviations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '5 Hz-PWM', 'description': 'RGn550 with a 5 Hz-pulsed wave mode light emission\n\nRGn550 5 Hz-PWM: RGn550 with a 5 Hz-pulsed wave mode light emission'}, {'id': 'OG001', 'title': '10 Hz-PWM', 'description': 'RGn550 with a 10 Hz-pulsed wave mode light emission\n\nRGn550 10 Hz-PWM: RGn550 with a 10 Hz-pulsed wave mode light emission'}], 'classes': [{'title': 'D0 before treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.5', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '1.5', 'spread': '1.0', 'groupId': 'OG001'}]}]}, {'title': 'D0 after treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.9', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '1.0', 'groupId': 'OG001'}]}]}, {'title': 'D7 before treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.0', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '1.0', 'groupId': 'OG001'}]}]}, {'title': 'D7 after treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.6', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '0.8', 'groupId': 'OG001'}]}]}, {'title': 'D52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.8', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '0.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'at Day 0 and Day 7 (before and after treatment session) and at Day 52', 'description': 'Evolution of the deviation assessed via the Cover test considering both eyes\n\nThe unilateral cover test was used in this investigation, which consists into covering one eye, horizontally moving a target 5 cm in front of both eyes, and then uncovering the covered eye and observing its reaction. If it fixes the target, this is normal: there is an orthophoria. If it moves to fix the target (restitution movement), the test is positive: there is a heterophoria in near vision. Patients who had visual corrections were to keep them during the test. The test was then repeated on the other eye.\n\nThe outcome of this test was a deviation value, considering both eyes, comprised between 0 (better outcome = normal fixation) and 3 (worst outcome = deviated eye without restitution movement).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients randomized and treated at least once (at inclusion visit)'}, {'type': 'SECONDARY', 'title': 'Evolution of Automated Oculomotor and Oculopostural Functions, as Assessed Through Deviations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '5 Hz-PWM', 'description': 'RGn550 with a 5 Hz-pulsed wave mode light emission\n\nRGn550 5 Hz-PWM: RGn550 with a 5 Hz-pulsed wave mode light emission'}, {'id': 'OG001', 'title': '10 Hz-PWM', 'description': 'RGn550 with a 10 Hz-pulsed wave mode light emission\n\nRGn550 10 Hz-PWM: RGn550 with a 10 Hz-pulsed wave mode light emission'}], 'classes': [{'title': 'Horizontal deviation : D0 before treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'Horizontal deviation : D0 after treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'Horizontal deviation : D7 before treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Horizontal deviation : D7 after treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Horizontal deviation : D52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'Vertical deviation of at least one eye : D0 before treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Vertical deviation of at least one eye : D0 after treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Vertical deviation of at least one eye : D7 before treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Vertical deviation of at least one eye : D7 after treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Vertical deviation of at least one eye : D52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'at Day 0 and Day 7 (before and after treatment session) and at Day 52', 'description': 'Evolution of the deviations assessed via Maddox rod test (horizontal deviation, vertical deviation of at least one eye)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients randomized and treated at least once (at inclusion visit)'}, {'type': 'SECONDARY', 'title': 'Evolution of the Balance Function, as Assessed Through Static Stabilometric Parameters', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '5 Hz-PWM', 'description': 'RGn550 with a 5 Hz-pulsed wave mode light emission\n\nRGn550 5 Hz-PWM: RGn550 with a 5 Hz-pulsed wave mode light emission'}, {'id': 'OG001', 'title': '10 Hz-PWM', 'description': 'RGn550 with a 10 Hz-pulsed wave mode light emission\n\nRGn550 10 Hz-PWM: RGn550 with a 10 Hz-pulsed wave mode light emission'}], 'classes': [{'title': 'D0 before treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '51.9', 'spread': '28.9', 'groupId': 'OG000'}, {'value': '54.9', 'spread': '41.4', 'groupId': 'OG001'}]}]}, {'title': 'D0 after treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '64.4', 'spread': '50.5', 'groupId': 'OG000'}, {'value': '62.9', 'spread': '60.2', 'groupId': 'OG001'}]}]}, {'title': 'D7 before treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '51.0', 'spread': '34.3', 'groupId': 'OG000'}, {'value': '56.8', 'spread': '33.2', 'groupId': 'OG001'}]}]}, {'title': 'D7 after treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '47.9', 'spread': '31.2', 'groupId': 'OG000'}, {'value': '59.9', 'spread': '41.9', 'groupId': 'OG001'}]}]}, {'title': 'D52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '50.9', 'spread': '33.9', 'groupId': 'OG000'}, {'value': '51.9', 'spread': '39.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'at Day 0 and Day 7 (before and after treatment session) and at Day 52', 'description': "Evolution of statokinesigram area with closed eyes\n\nThe statokinesigram is the projection onto a 2-dimensional space of the trajectory of the patient's center of pressure. Its area is measured in mm2. The larger the area is, the higher the patient's imbalance is.\n\nThe statokinesigram area was measured using the stabilometric platform KFORCE Plates on which the patients were asked to stand for 30 s with closed eyes.", 'unitOfMeasure': 'mm2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients randomized and treated at least once (at inclusion visit)'}, {'type': 'SECONDARY', 'title': 'Evolution of the Balance Function, as Assessed Through Static Stabilometric Parameters', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '5 Hz-PWM', 'description': 'RGn550 with a 5 Hz-pulsed wave mode light emission\n\nRGn550 5 Hz-PWM: RGn550 with a 5 Hz-pulsed wave mode light emission'}, {'id': 'OG001', 'title': '10 Hz-PWM', 'description': 'RGn550 with a 10 Hz-pulsed wave mode light emission\n\nRGn550 10 Hz-PWM: RGn550 with a 10 Hz-pulsed wave mode light emission'}], 'classes': [{'title': 'D0 before treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.5', 'spread': '4.1', 'groupId': 'OG000'}, {'value': '6.3', 'spread': '4.7', 'groupId': 'OG001'}]}]}, {'title': 'D0 after treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.9', 'spread': '4.3', 'groupId': 'OG000'}, {'value': '6.3', 'spread': '5.0', 'groupId': 'OG001'}]}]}, {'title': 'D7 before treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.7', 'spread': '3.5', 'groupId': 'OG000'}, {'value': '7.5', 'spread': '5.7', 'groupId': 'OG001'}]}]}, {'title': 'D7 after treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.0', 'spread': '4.7', 'groupId': 'OG000'}, {'value': '5.2', 'spread': '4.1', 'groupId': 'OG001'}]}]}, {'title': 'D52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.0', 'spread': '5.1', 'groupId': 'OG000'}, {'value': '6.4', 'spread': '4.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'at Day 0 and Day 7 (before and after treatment session) and at Day 52', 'description': "Evolution of the difference between left and right distributions of patient's body weight\n\nPatient's body weight left distribution, respectively right distribution, refer to patient's body weight distribution on his/her left foot, respectively right foot.\n\nThe left distribution and the right distribution are two percentages which sum makes 100%.\n\nWhen body weight is well distributed between left and right feet (coherent balance), the difference between left and right distributions is ≤ 5%.\n\nWhen body weight is not well distributed between left and right feet (uncoherent balance), the difference between left and right distributions is \\> 5%.\n\nThese distributions were measured using the stabilometric platform KFORCE Plates on which the patients were asked to stand for 30 s with closed eyes.", 'unitOfMeasure': '% of body weight distribution difference', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients randomized and treated at least once (at inclusion visit)'}, {'type': 'SECONDARY', 'title': 'Evolution of Executive Function, as Assessed With the Trail Making Test Part A and B (TMT A&B)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '5 Hz-PWM', 'description': 'RGn550 with a 5 Hz-pulsed wave mode light emission\n\nRGn550 5 Hz-PWM: RGn550 with a 5 Hz-pulsed wave mode light emission'}, {'id': 'OG001', 'title': '10 Hz-PWM', 'description': 'RGn550 with a 10 Hz-pulsed wave mode light emission\n\nRGn550 10 Hz-PWM: RGn550 with a 10 Hz-pulsed wave mode light emission'}], 'classes': [{'title': 'TMTA time to perform the task: D0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19.0', 'spread': '5.4', 'groupId': 'OG000'}, {'value': '21.2', 'spread': '7.0', 'groupId': 'OG001'}]}]}, {'title': 'TMTA time to perform the task: D7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15.7', 'spread': '4.0', 'groupId': 'OG000'}, {'value': '18.5', 'spread': '4.8', 'groupId': 'OG001'}]}]}, {'title': 'TMTB time to perform the task: D0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '53.5', 'spread': '20.1', 'groupId': 'OG000'}, {'value': '50.9', 'spread': '26.6', 'groupId': 'OG001'}]}]}, {'title': 'TMTB time to perform the task: D7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '42.5', 'spread': '12.7', 'groupId': 'OG000'}, {'value': '43.1', 'spread': '17.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'at Day 0 (before treatment session) and at Day 7 (after treatment session) Of note: for 46 patients, TMTB was performed before (rather than after) treatment at D7 (deviation)', 'description': 'Evolution of the Trail Making Test part A and B (TMT A\\&B) time to perform the task', 'unitOfMeasure': 's', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients randomized and treated at least once (at inclusion visit)'}, {'type': 'SECONDARY', 'title': 'Evolution of Concussion Syndrome Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '5 Hz-PWM', 'description': 'RGn550 with a 5 Hz-pulsed wave mode light emission\n\nRGn550 5 Hz-PWM: RGn550 with a 5 Hz-pulsed wave mode light emission'}, {'id': 'OG001', 'title': '10 Hz-PWM', 'description': 'RGn550 with a 10 Hz-pulsed wave mode light emission\n\nRGn550 10 Hz-PWM: RGn550 with a 10 Hz-pulsed wave mode light emission'}], 'classes': [{'title': 'Total number of symptoms: baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.4', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '0.4', 'groupId': 'OG001'}]}]}, {'title': 'Total number of symptoms : D0 before treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.6', 'spread': '3.7', 'groupId': 'OG000'}, {'value': '5.5', 'spread': '4.7', 'groupId': 'OG001'}]}]}, {'title': 'Total number of symptoms : D7 before treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.2', 'spread': '2.2', 'groupId': 'OG000'}, {'value': '1.7', 'spread': '4.2', 'groupId': 'OG001'}]}]}, {'title': 'Total number of symptoms : D14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.4', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '1.3', 'spread': '4.0', 'groupId': 'OG001'}]}]}, {'title': 'Total number of symptoms : D52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '3.1', 'groupId': 'OG001'}]}]}, {'title': 'Symptom severity score: baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.7', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '0.8', 'groupId': 'OG001'}]}]}, {'title': 'Symptom severity score: D0 before treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.5', 'spread': '7.4', 'groupId': 'OG000'}, {'value': '10.8', 'spread': '13.2', 'groupId': 'OG001'}]}]}, {'title': 'Symptom severity score: D7 before treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.1', 'spread': '4.2', 'groupId': 'OG000'}, {'value': '3.5', 'spread': '11.9', 'groupId': 'OG001'}]}]}, {'title': 'Symptom severity score: D14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.8', 'spread': '2.2', 'groupId': 'OG000'}, {'value': '2.9', 'spread': '11.1', 'groupId': 'OG001'}]}]}, {'title': 'Symptom severity score: D52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.3', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '2.1', 'spread': '9.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': "at baseline (which represents the patient's state before the concussion as estimated/assessed by the patient on D0), Day 0 (before treatment session), Day 7 (before treatment session), Day 14 and Day 52", 'description': 'Evolution of the SCAT5 (Sport Concussion Assessment Tool - 5th edition) score\n\nThe SCAT5 is a standardized tool for evaluating concussions designed for use by physicians and licensed healthcare professionals. With this tool, the patient rates the intensity of every symptom from 0 (none) to 6 (severe) using a form. This enables to calculate the total number of symptoms (subscore from 0 to 22) and the symptom severity score (subscore from 0 to 132).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients randomized and treated at least once (at inclusion visit)'}, {'type': 'SECONDARY', 'title': 'Evolution of the Concussion Blood Markers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '5 Hz-PWM', 'description': 'RGn550 with a 5 Hz-pulsed wave mode light emission\n\nRGn550 5 Hz-PWM: RGn550 with a 5 Hz-pulsed wave mode light emission'}, {'id': 'OG001', 'title': '10 Hz-PWM', 'description': 'RGn550 with a 10 Hz-pulsed wave mode light emission\n\nRGn550 10 Hz-PWM: RGn550 with a 10 Hz-pulsed wave mode light emission'}], 'classes': [{'title': 'GFAP : D0 before treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '95.3', 'spread': '75.6', 'groupId': 'OG000'}, {'value': '82.5', 'spread': '40.2', 'groupId': 'OG001'}]}]}, {'title': 'GFAP : D52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '67.7', 'spread': '29.6', 'groupId': 'OG000'}, {'value': '49.8', 'spread': '21.5', 'groupId': 'OG001'}]}]}, {'title': 'UCHL1 : D0 before treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.0', 'spread': '20.4', 'groupId': 'OG000'}, {'value': '3.9', 'spread': '4.4', 'groupId': 'OG001'}]}]}, {'title': 'UCHL1 : D52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.3', 'spread': '13.3', 'groupId': 'OG000'}, {'value': '5.0', 'spread': '4.5', 'groupId': 'OG001'}]}]}, {'title': 'IL-1RA : D0 before treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '367.8', 'spread': '231.8', 'groupId': 'OG000'}, {'value': '413.3', 'spread': '318.7', 'groupId': 'OG001'}]}]}, {'title': 'IL-1RA : D52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '324.2', 'spread': '122.5', 'groupId': 'OG000'}, {'value': '452.5', 'spread': '423.8', 'groupId': 'OG001'}]}]}, {'title': 'IL-10 : D0 before treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.74', 'spread': '1.88', 'groupId': 'OG000'}, {'value': '0.33', 'spread': '0.16', 'groupId': 'OG001'}]}]}, {'title': 'IL-10 : D52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.28', 'spread': '0.08', 'groupId': 'OG000'}, {'value': '0.51', 'spread': '0.47', 'groupId': 'OG001'}]}]}, {'title': 'IL-4 : D0 before treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.02', 'spread': '0.01', 'groupId': 'OG000'}, {'value': '0.02', 'spread': '0.01', 'groupId': 'OG001'}]}]}, {'title': 'IL-4 : D52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.05', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '0.05', 'spread': '0.04', 'groupId': 'OG001'}]}]}, {'title': 'IL-6 : D0 before treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.25', 'spread': '2.32', 'groupId': 'OG000'}, {'value': '2.36', 'spread': '3.44', 'groupId': 'OG001'}]}]}, {'title': 'IL-6 : D52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.97', 'spread': '1.85', 'groupId': 'OG000'}, {'value': '1.35', 'spread': '2.19', 'groupId': 'OG001'}]}]}, {'title': 'S100B : D0 before treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '25.7', 'spread': '35.4', 'groupId': 'OG000'}, {'value': '17.6', 'spread': '10.9', 'groupId': 'OG001'}]}]}, {'title': 'S100B : D52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '25.0', 'spread': '36.0', 'groupId': 'OG000'}, {'value': '17.2', 'spread': '10.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'at Day 0 (before treatment session) and at Day 52', 'description': 'Evolution of the concentration of:\n\n* Anti-inflammatory cytokines InterLeukin (IL)-1 receptor antagonist, IL-4, IL-6, IL-10, IL-11 and IL-13\n* S100 calcium binding protein B (S100B)\n* Glial Fibrillary Acidic Protein (GFAP)\n* Ubiquitin C-terminal Hydrolase-L1 (UCH-L1) Of note: IL-11 and IL-13 could eventually not be analyzed due to undetectable low concentrations', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients randomized and treated at least once (at inclusion visit)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '5 Hz-PWM', 'description': 'RGn550 with a 5 Hz-pulsed wave mode light emission\n\nRGn550 5 Hz-PWM: RGn550 with a 5 Hz-pulsed wave mode light emission'}, {'id': 'FG001', 'title': '10 Hz-PWM', 'description': 'RGn550 with a 10 Hz-pulsed wave mode light emission\n\nRGn550 10 Hz-PWM: RGn550 with a 10 Hz-pulsed wave mode light emission'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '24'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '24'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Recruitment period : 11 October 2022 - 02 May 2023 One site located in France'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': '5 Hz-PWM', 'description': 'RGn550 with a 5 Hz-pulsed wave mode light emission\n\nRGn550 5 Hz-PWM: RGn550 with a 5 Hz-pulsed wave mode light emission'}, {'id': 'BG001', 'title': '10 Hz-PWM', 'description': 'RGn550 with a 10 Hz-pulsed wave mode light emission\n\nRGn550 10 Hz-PWM: RGn550 with a 10 Hz-pulsed wave mode light emission'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '24.9', 'spread': '5.2', 'groupId': 'BG000'}, {'value': '25.1', 'spread': '5.1', 'groupId': 'BG001'}, {'value': '25.0', 'spread': '5.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'France', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Time between concussion and inclusion', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2.4', 'spread': '0.5', 'groupId': 'BG000'}, {'value': '2.3', 'spread': '0.4', 'groupId': 'BG001'}, {'value': '2.3', 'spread': '0.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'days', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Concussion history', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2.0', 'spread': '2.1', 'groupId': 'BG000'}, {'value': '1.4', 'spread': '1.6', 'groupId': 'BG001'}, {'value': '1.7', 'spread': '1.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'concussion', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Patients randomized and treated at least once (at the inclusion visit)'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-08-11', 'size': 2023410, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_002.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-02-27T11:22', 'hasProtocol': True}, {'date': '2023-08-03', 'size': 677050, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_003.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-02-27T11:23', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'An interventional, prospective, monocentric, randomized, comparative and simple-blinded pilot clinical investigation'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-10-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2023-06-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-27', 'studyFirstSubmitDate': '2022-11-22', 'resultsFirstSubmitDate': '2024-07-05', 'studyFirstSubmitQcDate': '2022-12-02', 'lastUpdatePostDateStruct': {'date': '2025-03-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-10-16', 'studyFirstPostDateStruct': {'date': '2022-12-12', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-12-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Incidence of RGn550's Adverse Device Effects (ADEs)", 'timeFrame': 'Throughout the investigation (from Day 0 to Day 52)', 'description': 'Percentage of patients with at least one ADE'}], 'secondaryOutcomes': [{'measure': "Incidence of RGn550's ADEs Per Severity (Mild, Moderate and Severe)", 'timeFrame': 'Throughout the investigation (from Day 0 to Day 52)', 'description': 'Percentage of patients with at least one ADE per severity (mild, moderate and severe)'}, {'measure': "Incidence of RGn550's Adverse Events (AEs)", 'timeFrame': 'Throughout the investigation (from Day 0 to Day 52)', 'description': 'Percentage of patients with at least one AE'}, {'measure': "Incidence of RGn550's Device Deficiencies (DDs)", 'timeFrame': 'Throughout the investigation (from Day 0 to Day 52)', 'description': 'Percentage of patients with at least one DD'}, {'measure': 'Evolution of Automated Oculomotor and Oculopostural Functions, as Assessed Through the Convergence', 'timeFrame': 'at Day 0 and Day 7 (before and after treatment session) and at Day 52', 'description': 'Evolution of the Near Point of Convergence (NPC)'}, {'measure': 'Evolution of Automated Oculomotor and Oculopostural Functions, as Assessed Through Deviations', 'timeFrame': 'at Day 0 and Day 7 (before and after treatment session) and at Day 52', 'description': 'Evolution of the deviation assessed via the Cover test considering both eyes\n\nThe unilateral cover test was used in this investigation, which consists into covering one eye, horizontally moving a target 5 cm in front of both eyes, and then uncovering the covered eye and observing its reaction. If it fixes the target, this is normal: there is an orthophoria. If it moves to fix the target (restitution movement), the test is positive: there is a heterophoria in near vision. Patients who had visual corrections were to keep them during the test. The test was then repeated on the other eye.\n\nThe outcome of this test was a deviation value, considering both eyes, comprised between 0 (better outcome = normal fixation) and 3 (worst outcome = deviated eye without restitution movement).'}, {'measure': 'Evolution of Automated Oculomotor and Oculopostural Functions, as Assessed Through Deviations', 'timeFrame': 'at Day 0 and Day 7 (before and after treatment session) and at Day 52', 'description': 'Evolution of the deviations assessed via Maddox rod test (horizontal deviation, vertical deviation of at least one eye)'}, {'measure': 'Evolution of the Balance Function, as Assessed Through Static Stabilometric Parameters', 'timeFrame': 'at Day 0 and Day 7 (before and after treatment session) and at Day 52', 'description': "Evolution of statokinesigram area with closed eyes\n\nThe statokinesigram is the projection onto a 2-dimensional space of the trajectory of the patient's center of pressure. Its area is measured in mm2. The larger the area is, the higher the patient's imbalance is.\n\nThe statokinesigram area was measured using the stabilometric platform KFORCE Plates on which the patients were asked to stand for 30 s with closed eyes."}, {'measure': 'Evolution of the Balance Function, as Assessed Through Static Stabilometric Parameters', 'timeFrame': 'at Day 0 and Day 7 (before and after treatment session) and at Day 52', 'description': "Evolution of the difference between left and right distributions of patient's body weight\n\nPatient's body weight left distribution, respectively right distribution, refer to patient's body weight distribution on his/her left foot, respectively right foot.\n\nThe left distribution and the right distribution are two percentages which sum makes 100%.\n\nWhen body weight is well distributed between left and right feet (coherent balance), the difference between left and right distributions is ≤ 5%.\n\nWhen body weight is not well distributed between left and right feet (uncoherent balance), the difference between left and right distributions is \\> 5%.\n\nThese distributions were measured using the stabilometric platform KFORCE Plates on which the patients were asked to stand for 30 s with closed eyes."}, {'measure': 'Evolution of Executive Function, as Assessed With the Trail Making Test Part A and B (TMT A&B)', 'timeFrame': 'at Day 0 (before treatment session) and at Day 7 (after treatment session) Of note: for 46 patients, TMTB was performed before (rather than after) treatment at D7 (deviation)', 'description': 'Evolution of the Trail Making Test part A and B (TMT A\\&B) time to perform the task'}, {'measure': 'Evolution of Concussion Syndrome Symptoms', 'timeFrame': "at baseline (which represents the patient's state before the concussion as estimated/assessed by the patient on D0), Day 0 (before treatment session), Day 7 (before treatment session), Day 14 and Day 52", 'description': 'Evolution of the SCAT5 (Sport Concussion Assessment Tool - 5th edition) score\n\nThe SCAT5 is a standardized tool for evaluating concussions designed for use by physicians and licensed healthcare professionals. With this tool, the patient rates the intensity of every symptom from 0 (none) to 6 (severe) using a form. This enables to calculate the total number of symptoms (subscore from 0 to 22) and the symptom severity score (subscore from 0 to 132).'}, {'measure': 'Evolution of the Concussion Blood Markers', 'timeFrame': 'at Day 0 (before treatment session) and at Day 52', 'description': 'Evolution of the concentration of:\n\n* Anti-inflammatory cytokines InterLeukin (IL)-1 receptor antagonist, IL-4, IL-6, IL-10, IL-11 and IL-13\n* S100 calcium binding protein B (S100B)\n* Glial Fibrillary Acidic Protein (GFAP)\n* Ubiquitin C-terminal Hydrolase-L1 (UCH-L1) Of note: IL-11 and IL-13 could eventually not be analyzed due to undetectable low concentrations'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Concussion', 'mTBI', 'Neurostimulation', 'Optics and photonics', 'Photobiomodulation', 'Brain Diseases', 'Central Nervous System Diseases', 'Nervous System Diseases', 'Medical Device'], 'conditions': ['Acute Concussion Syndrome']}, 'descriptionModule': {'briefSummary': 'This is a controlled investigation, with randomization of the patients, which aims at evaluating the safety and performance of device RGn550 in treating sportspeople suffering from acute concussion syndrome. RGn550 is a non-invasive medical device which is applied on the head (helmet). It combines 2 technologies:\n\n* PhotoBioModulation (PBM), which involves exposure to light from the red to near-infrared wavelengths using lasers and Light Emitting Diodes (LEDs)\n* Static Magnetic Stimulation (SMS), which consists in the application of a static magnetic field.\n\nConsidering previous investigations, this innovative technology could reduce brain inflammation implicated in concussion syndrome.', 'detailedDescription': 'This monocentric investigation is planned to include 50 patients who will be followed up to 52 days.\n\nPatients meeting all eligibility criteria will be randomized on a 1: 1 ratio into one of the two groups differing in terms of light exposure duty cycle (duty cycle is 50%) treatment frequency: RGn550 device with a 5 Hz-pulsed wave mode light emission frequency and RGn550 device with a 10 Hz-pulsed wave mode light emission frequency. The RGn550 device will be applied to the patients during two 20-min treatment sessions at 1 week apart.\n\nThree onsite visits will be performed at the following timepoints:\n\n* Day 0 (D0): Inclusion, randomization (to the 5 Hz-PWM or 10Hz-PWM treatment group) and first treatment session with RGn550\n* Day 7 (D7): Second treatment session with RGn550\n* Day 52 (D52): Evaluation 45 days after the last treatment session. In addition, at Day 14 (D14), the patient will be asked to remotely assess his/her concussion syndrome symptoms.\n\nAt inclusion visit, after verification of the eligibility criteria, data regarding patients will be collected: demographic data, result of pregnancy test for women, concussion history, concomitant medications.\n\nAt each visit:\n\n* The patient will be asked to assess his/her concussion syndrome symptoms via the SCAT5 evaluation tool\n* The functions possibly affected by the concussion syndrome will be assessed at each visit:\n\nO The executive function via the TMT A\\&B O The automated oculomotor and oculopostural functions via the NPC, cover test and Maddox Rod test O The balance via static stabilometric tests\n\n•all AEs and device deficiencies will be collected A blood sample will be collected at D0 and D52 to measure blood markers of concussion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female aged at least 18 years old\n* Suffering from concussion syndrome resulting from a shock that occurred during sport practice less than 72h ago, as confirmed by neurological examination via the Head Injury Assessment - Form 3 (HIA3) tool\n* Affiliated to French social security\n* Who provided a dated and signed informed consent form.\n\nNon-inclusion Criteria:\n\n* Patient protected by a French legal measure ("sauvegarde de justice", "tutelle" or "curatelle")\n* Patient not able to express his/her consent\n* Patient deprived of liberty or hospitalized without consent\n* Woman who is pregnant or breastfeeding, or who plans to become pregnant or breastfeeding during the investigation, or who has the capacity to conceive but is not using a reliable contraceptive method as deemed by the investigator\n* Patient living in a medical facility\n* Patient who experienced a surgery at the treatment application area (head) within 3 months prior to inclusion\n* Patient with skin lesions on the treatment application area (head)\n* Patient with a short-term life-threatening pathology (e.g., evolving cancer; non-stable heart failure; severe hepatic, renal or respiratory failure, etc.)\n* Patient diagnosed with a heart attack within 3 months prior to inclusion\n* Patient implanted with ferromagnetic material\n* Patient implanted with a pacemaker\n* Patient with a risk of epileptic seizure or other non-degenerative central nervous system diseases\n* Patient with major physical or neurosensorial disorders that may interfere with assessments\n* Patient with chronic psychosis or psychotic episodes\n* Patient addicted to alcohol or drugs\n* Patient treated with antidepressant or benzodiazepine\n* Patient who participated to another investigation/study involving the use of an investigational medical device/drug within the 30 days prior inclusion\n* Patient not able to meet treatment sessions as deemed by the investigator\n* Patient not able to complete requested investigation assessments as deemed by the investigator.'}, 'identificationModule': {'nctId': 'NCT05647304', 'acronym': 'RECOVERY', 'briefTitle': 'Pilot Clinical Investigation Evaluating the Safety and Performance of RGn550 in Treating Sportspeople Suffering From Acute Concussion Syndrome', 'organization': {'class': 'INDUSTRY', 'fullName': 'REGEnLIFE SAS'}, 'officialTitle': 'Pilot Clinical Investigation Evaluating the Safety and Performance of RGn550 in Treating Sportspeople Suffering From Acute Concussion Syndrome - A Prospective, Comparative, Randomized, Simple-blinded, Monocentric Investigation [RGncon Investigation]', 'orgStudyIdInfo': {'id': 'RGnCON'}, 'secondaryIdInfos': [{'id': '2022-A01319-34', 'type': 'REGISTRY', 'domain': 'IDRCB number. French competent authority : Agence Nationale de sécurité du médicament et des produits de santé (ANSM)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': '5 Hz-PWM', 'description': 'RGn550 with a 5 Hz-pulsed wave mode light emission', 'interventionNames': ['Device: RGn550 5 Hz-PWM']}, {'type': 'OTHER', 'label': '10 Hz-PWM', 'description': 'RGn550 with a 10 Hz-pulsed wave mode light emission', 'interventionNames': ['Device: RGn550 10 Hz-PWM']}], 'interventions': [{'name': 'RGn550 5 Hz-PWM', 'type': 'DEVICE', 'description': 'RGn550 with a 5 Hz-pulsed wave mode light emission', 'armGroupLabels': ['5 Hz-PWM']}, {'name': 'RGn550 10 Hz-PWM', 'type': 'DEVICE', 'description': 'RGn550 with a 10 Hz-pulsed wave mode light emission', 'armGroupLabels': ['10 Hz-PWM']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75015', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Européen Georges Pompidou', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'REGEnLIFE SAS', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'RCTs', 'class': 'INDUSTRY'}, {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}