Ignite Creation Date:
2025-12-25 @ 1:47 AM
Ignite Modification Date:
2025-12-26 @ 6:07 PM
Study NCT ID:
NCT05992194
Status:
COMPLETED
Last Update Posted:
2024-02-16
First Post:
2023-08-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Repeatability Assessment of Neurovisual Tasks for the Construction of a New Concussion Monitoring Tool (SPORTICARE)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}], 'ancestors': [{'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-08-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2023-11-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-15', 'studyFirstSubmitDate': '2023-08-04', 'studyFirstSubmitQcDate': '2023-08-11', 'lastUpdatePostDateStruct': {'date': '2024-02-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of repeatability when performing pro-saccades', 'timeFrame': 'Day 0', 'description': 'Latency (ms)'}, {'measure': 'Assessment of repeatability when performing anti-saccades', 'timeFrame': 'Day 0', 'description': 'Latency (ms)'}, {'measure': 'Assessment of repeatability when performing memory tricks', 'timeFrame': 'Day 0', 'description': 'Positional error (degrees)'}, {'measure': 'Assessment of repeatability of the number of saccades when performing self-paced saccades', 'timeFrame': 'Day 0', 'description': 'number of saccades (n) performed between the two targets in the allotted time (15 seconds)'}, {'measure': 'Assessment of repeatability of pupil cycle time when performing self-paced saccades', 'timeFrame': 'Day 0', 'description': 'Pupil Cycle Time (PCT): average frequency of pupillary oscillation (Hz)'}, {'measure': 'Assessment of repeatability when performing pro-saccades', 'timeFrame': 'Between Day 7 and Day 21', 'description': 'Latency (ms)'}, {'measure': 'Assessment of repeatability when performing anti-saccades', 'timeFrame': 'Between Day 7 and Day 21', 'description': 'Latency (ms)'}, {'measure': 'Assessment of repeatability when performing memory tricks', 'timeFrame': 'Between Day 7 and Day 21', 'description': 'Positional error (degrees)'}, {'measure': 'Assessment of repeatability of the number of saccades when performing self-paced saccades', 'timeFrame': 'Between Day 7 and Day 21', 'description': 'number of saccades (n) performed between the two targets in the allotted time (15 seconds)'}, {'measure': 'Assessment of repeatability of pupil cycle time when performing self-paced saccades', 'timeFrame': 'Between Day 7 and Day 21', 'description': 'Pupil Cycle Time (PCT): average frequency of pupillary oscillation (Hz)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Traumatic Brain Injury']}, 'descriptionModule': {'briefSummary': "Traumatic brain injury (TBI) is a condition that occurs when a mechanical blow to the head causes damage to the brain. The diagnosis of this pathology requires the evaluation of several dimensions, including clinical symptoms, physical signs, cognitive disorders, behavioral and sleep disturbances and state of consciousness. This multidimensional approach provides a comprehensive and accurate assessment of head injury and its severity.\n\nThe Berlin Consensus of the International Conference on Concussion in Contact Risk Sports held in Berlin in 2016 (McCrory et al., 2017) emphasized that the management of a CTE must be multimodal and multidisciplinary.\n\nThis expert consensus converged on a tool that is now the most widely used in protocols studying concussion in sports at risk of BTI. This tool, the SCAT 5 (Sports Concussion Assessment Tool), combines symptom assessment, cognitive examination, neurological examination (oculomotricity, balance) and immediate and delayed memory.\n\nHowever, it requires the intervention of a medical expert to assess the clinical signs of the concussed athlete. Hänninen et al (2021) showed that test-retest reproducibility was very good for the clinical symptomatology subscore, but poor or average for the subscores summarizing cognitive tests and balance assessment.\n\nClinicians now need to be able to better assess the severity of damage following head injury, and to monitor the patient's progress. This will improve the management of concussed athletes right up to their eventual return to sporting activity.\n\nThe ultimate aim of our project is to develop and optimize an easily exportable multimodal concussion assessment tool, based on the use of a virtual reality headset, which will enable us to objectively characterize the state and evolution of a subject after a TCE. This will enable the assessment of neuro-visual functions and compensations in the concussed patient, revealing a higher attentional cost characterized by instability of orthostatic control, higher blink frequency and larger pupil size.\n\nThe multimodal tool will be built from the results of various tests:\n\n* Standardized oculomotor tasks(pro-saccades, anti-saccades, smooth pursuit, memory guided saccades, self paced saccades)\n* Orthostatic balance control to assess postural compensations and estimate attentional cost during oculomotor tasks.\n* Pupil dynamics using the Pupil Cycle Time (PCT) test. The aim of this exploratory study is to determine the repeatability of measurements provided by the SPORTiCARE virtual reality headset during different tasks."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Group of 25 healthy volunteers', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Visual acuity of 10/10,\n* Express consent to participate in the study,\n* Affiliated (or beneficiary) of a social insurance scheme.\n\nExclusion Criteria:\n\n* History of Cranioencephalic Trauma,\n* Protected persons: pregnant women, parturients, nursing mothers, persons deprived of their liberty by judicial or administrative decision, minors, and persons subject to a legal protection measure (guardianship or curatorship).\n* Subjects suffering from a degenerative disease or any other illness which could interfere with the evaluations planned during this study (migraine, balance disorders, vertigo).\n* Subjects with ophthalmological pathologies affecting visual functions (oculomotor dysfunction, diplopia, strabismus).\n* Known history of convergence and/or accommodation insufficiency.\n* Subject declaring to the investigator in charge of anamnesis, consumption of psychoactive and psychotropic drugs, medications (anti-anxiety, antidepressant, anticonvulsant, opiate, analgesic, anti-hypertensive) or level 3 medications, which may have effects on vision.\n* Unavailability of participant for evaluation sessions.\n* Inability to comply with study task instructions.'}, 'identificationModule': {'nctId': 'NCT05992194', 'acronym': 'SPORTiCARE', 'briefTitle': 'Repeatability Assessment of Neurovisual Tasks for the Construction of a New Concussion Monitoring Tool (SPORTICARE)', 'organization': {'class': 'NETWORK', 'fullName': 'Fondation Ophtalmologique Adolphe de Rothschild'}, 'officialTitle': 'Exploratory Study Analyzing the Repeatability of Neurovisual Tasks for the Construction of a New Concussion Monitoring Tool', 'orgStudyIdInfo': {'id': 'SBN_2023_2'}}, 'armsInterventionsModule': {'interventions': [{'name': 'multimodal oculomotor measurements', 'type': 'OTHER', 'description': '* Visual assessment to ensure that the subject meets the inclusion and non-inclusion criteria, including anamnesis and the following visual tests: Lang stereotest, H-test ocular motility, convergence, masking and accommodative rock.\n* Evaluation by experimenter A (60 min)\n\n * Neuro-ophthalmological tests on screen\n * Neuro-ophthalmological tests in VR headset\n* Evaluation by experimenter B (60 min)\n\n * Neuro-ophthalmological tests on screen\n * Neuro-ophthalmological tests in VR helmet The sequence of experimenters A-B or B-A will be randomized.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '75012', 'city': 'Paris', 'country': 'France', 'facility': 'Streetlab - Institut de la Vision', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondation Ophtalmologique Adolphe de Rothschild', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}