Ignite Creation Date:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2026-01-01 @ 7:10 AM
Study NCT ID:
NCT05514457
Status:
COMPLETED
Last Update Posted:
2024-09-25
First Post:
2022-08-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Visual Dyslexia Remediation Protocols - Dyslexia REMEDIATION
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004410', 'term': 'Dyslexia'}], 'ancestors': [{'id': 'D007806', 'term': 'Language Disorders'}, {'id': 'D003147', 'term': 'Communication Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D000067559', 'term': 'Specific Learning Disorder'}, {'id': 'D007859', 'term': 'Learning Disabilities'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010775', 'term': 'Photic Stimulation'}, {'id': 'D000076342', 'term': 'Protein-Arginine Deiminases'}, {'id': 'D008027', 'term': 'Light'}], 'ancestors': [{'id': 'D010812', 'term': 'Physical Stimulation'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D060733', 'term': 'Electromagnetic Radiation'}, {'id': 'D055590', 'term': 'Electromagnetic Phenomena'}, {'id': 'D060328', 'term': 'Magnetic Phenomena'}, {'id': 'D055585', 'term': 'Physical Phenomena'}, {'id': 'D055620', 'term': 'Optical Phenomena'}, {'id': 'D011827', 'term': 'Radiation'}, {'id': 'D011840', 'term': 'Radiation, Nonionizing'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2024-03-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-24', 'studyFirstSubmitDate': '2022-08-05', 'studyFirstSubmitQcDate': '2022-08-22', 'lastUpdatePostDateStruct': {'date': '2024-09-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'reading performance', 'timeFrame': 'for arm 1: at baseline at 1 month at 2 month at 3 month For arm 2: 4 times in the same day, 4 consecutive reading sessions with a break in-between of minimum 5 minutes', 'description': 'change in reading time'}, {'measure': 'reading performance', 'timeFrame': 'for arm 1: at baseline at 1 month at 2 month at 3 month For arm 2: 4 times in the same day, 4 consecutive reading sessions with a break in-between of minimum 5 minutes', 'description': 'change in number of errors'}], 'secondaryOutcomes': [{'measure': 'score of Elementary Visuo-Spatial Perception test', 'timeFrame': 'one time at baseline', 'description': 'comparisons of score of (lengths, sizes, angles and relative positions within and between objects). Minimum score = 36 and maximum (better) score = 72'}, {'measure': 'visual attention span', 'timeFrame': 'one time at baseline', 'description': 'number of letters identified in a single ocular fixation (200 ms)'}, {'measure': 'Visual search time', 'timeFrame': 'one time at baseline', 'description': 'average visual search time of symbols versus colored objects'}, {'measure': 'performance score on the phonology tests (EVALéo 6-15 = Evaluation of written language and oral language 6-15 years)', 'timeFrame': 'one time at baseline', 'description': 'metaphonology = removal of phonemes. Minimum score = 0 and maximum (better) score = 20'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dyslexia', 'Remediation', 'Visual attention span', 'Visual search'], 'conditions': ['Dyslexia']}, 'descriptionModule': {'briefSummary': 'Dyslexia is first described as a phonological deficit. Several studies report a neurovisual deficit in dyslexics. Some dyslexics have a visual deficit without phonological impairment, others have a pure phonological deficit, and still others have both types of deficits. From this observation the idea emerged to propose specific remediation protocols for people with visual impairments and to assess their effects on reading. At the theoretical level, if visual stimulation is able to improve reading performance, it is the demonstration of the existence of visual origin of dyslexia. At the clinical level, such a result not only opens the prospect of a different and more adapted rehabilitation for these types of dyslexia, but also the prospect, if the visual deficits are pre-existing to the learning of reading, to use them for early diagnosis and management.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '8 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female\n* Aged 8 to 12\n* Diagnosed dyslexics\n* Normal or corrected to normal vision\n* Legal guardians of children subjects providing their free, informed and written consent to participate in the study; With the child also giving orally his consent to participate.\n\nExclusion Criteria:\n\n* other neurodevelopmental problem\n* strabismus, amblyopia\n\nFor the glasses (group 2) : epileptic child are excluded'}, 'identificationModule': {'nctId': 'NCT05514457', 'acronym': 'Dyslexie REMED', 'briefTitle': 'Assessment of Visual Dyslexia Remediation Protocols - Dyslexia REMEDIATION', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Assessment of Visual Dyslexia Remediation Protocols - Dyslexia REMEDIATION', 'orgStudyIdInfo': {'id': '69HCL21_0736'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'remediation group 1', 'description': 'dyslexic children', 'interventionNames': ['Behavioral: visual stimulation with I pad']}, {'type': 'EXPERIMENTAL', 'label': 'remediation group 2', 'description': 'dyslexic children', 'interventionNames': ['Behavioral: visual stimulation with lamp']}], 'interventions': [{'name': 'visual stimulation with I pad', 'type': 'BEHAVIORAL', 'description': 'At the beginning of the study, for baseline condition, children will do 4 tests (visuo-spatial perception test, visual attention span, visual research, phonology tests).\n\nIn the first group of the study, the children will do visual research exercises on I pad 10 minutes per day during one month = remediation. They will also do 4 reading aloud tests, once a month, for 3 months. The remediation exercises will be realized during the first, second or third month.', 'armGroupLabels': ['remediation group 1']}, {'name': 'visual stimulation with lamp', 'type': 'BEHAVIORAL', 'description': 'At the beginning of the study, for baseline condition, children will do the 4 tests like group 1.\n\nIn the second group of the study, the children will do reading aloud tests, with lamp adjusted with different parameters = remediation (passive visual stimulation of a specific frequency believed to promote visual processing of written symbols).', 'armGroupLabels': ['remediation group 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69500', 'city': 'Bron', 'state': 'Auvergne-Rhône-Alpes', 'country': 'France', 'facility': 'Centre de Recherche en Neurosciences de Lyon', 'geoPoint': {'lat': 45.73865, 'lon': 4.91303}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}