Ignite Creation Date:
2025-12-24 @ 5:55 PM
Ignite Modification Date:
2026-02-25 @ 4:48 PM
Study NCT ID:
NCT06389968
Status:
RECRUITING
Last Update Posted:
2024-11-22
First Post:
2024-04-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Light Stimulation to Improve Visual Function After Optic Neuritis in Persons with Multiple Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020529', 'term': 'Multiple Sclerosis, Relapsing-Remitting'}, {'id': 'D009902', 'term': 'Optic Neuritis'}], 'ancestors': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}, {'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D009901', 'term': 'Optic Nerve Diseases'}, {'id': 'D003389', 'term': 'Cranial Nerve Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'sham-controlled'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-20', 'studyFirstSubmitDate': '2024-04-22', 'studyFirstSubmitQcDate': '2024-04-25', 'lastUpdatePostDateStruct': {'date': '2024-11-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'High contrast visual sensitivity', 'timeFrame': 'before intervention, directly after the first stimulation, after 12 days of training (stimulation) as 24 hour retention, and at 22 days post-intervention (retention)', 'description': 'Visual resolution with Sloan chart'}], 'secondaryOutcomes': [{'measure': 'Low contrast visual sensitivity', 'timeFrame': 'before intervention, directly after the first stimulation, after 12 days of training (stimulation) as 24 hour retention, and at 22 days post-intervention (retention)', 'description': 'Sloan chart at 2.5%'}, {'measure': 'Visually evoked potentials', 'timeFrame': 'before intervention, directly after the first stimulation, after 12 days of training (stimulation) as 24 hour retention, and at 22 days post-intervention (retention)', 'description': 'Visually evoked potential'}, {'measure': 'Optical coherence tomography', 'timeFrame': 'before intervention, directly after the first stimulation, after 12 days of training (stimulation) as 24 hour retention, and at 22 days post-intervention (retention)', 'description': 'Optical coherence tomography'}, {'measure': 'Optical coherence tomographic angiography', 'timeFrame': 'before intervention, directly after the first stimulation, after 12 days of training (stimulation) as 24 hour retention, and at 22 days post-intervention (retention)', 'description': 'Optical coherence tomographic angiography'}, {'measure': 'Color contrast', 'timeFrame': 'before intervention, directly after the first stimulation, after 12 days of training (stimulation) as 24 hour retention, and at 22 days post-intervention (retention)', 'description': 'Color contrast threshold (3 colors)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Multiple Sclerosis, Relapsing-Remitting', 'Optic Neuritis']}, 'descriptionModule': {'briefSummary': 'The aim of this monocentric randomized controlled intervention study is to improve visual function in persons with multiple sclerosis following optic neuritis (neuritis nervi optici) by means of a light stimulation.\n\nIn the treatment arm, two 80-second light stimulations are to be administered daily for 12 days in 25 persons with multiple sclerosis following recent optic neuritis (1-3 months). For the standardized application of light stimulation in the sense of standardized training, the light stimulation is to be carried out by watching a generated flicker video on a mobile phone. In a sham-intervened control group (sample size 25), the spontaneous course after optic neuritis will be recorded in parallel. Intensive neuronal stimulation of the visual pathway will be used to stimulate regenerative processes, which will be recorded by means of changes in high-contrast visual acuity (primary endpoint). Secondary endpoints are changes in a colored-contrast test, in 2.5% low contrast visual acuity, the peak conduction latency of visual evoked potentials, and retinal layer thicknesses and vessel densities measured in optical coherence tomography and optical coherence tomorgraphic angiography. These physiological parameters should help to understand the underlying processes of a potentially altered visual performance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Relapsing remitting multiple sclerosis or clinically isolated syndrome or no indication of chronic inflammatory central nervous system disease\n* Age 18-60 years\n* Optic neuritis within 1-3 months\n\nExclusion Criteria:\n\n* Epilepsy\n* Light-triggered migraine\n* Insufficient vision correction\n* Retinal disease (glaucoma, macular edema, macula degeneration, ...)'}, 'identificationModule': {'nctId': 'NCT06389968', 'acronym': 'ONSTIM', 'briefTitle': 'Light Stimulation to Improve Visual Function After Optic Neuritis in Persons with Multiple Sclerosis', 'organization': {'class': 'OTHER', 'fullName': 'Technical University of Munich'}, 'officialTitle': 'Lichtstimulation Zur Verbesserung Der Sehleistung Bei Patientinnen Und Patienten Mit Multipler Sklerose Nach Sehnerventzündung', 'orgStudyIdInfo': {'id': '2023-491-S-KH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Light stimulation', 'description': 'Experimental light stimulation (3 colors at 20 Hertz each for 80 seconds twice a day).', 'interventionNames': ['Device: Light stimulation']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham light stimulation', 'description': 'Sham light stimulation (white screen for 80 seconds twice a day).', 'interventionNames': ['Device: Sham light stimulation']}], 'interventions': [{'name': 'Light stimulation', 'type': 'DEVICE', 'description': 'see arm description', 'armGroupLabels': ['Light stimulation']}, {'name': 'Sham light stimulation', 'type': 'DEVICE', 'description': 'see arm description', 'armGroupLabels': ['Sham light stimulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '81675', 'city': 'Munich', 'state': 'Bavaria', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Philipp Gulde Gulde, Dr. phil.', 'role': 'CONTACT', 'email': 'philipp.gulde@tum.de', 'phone': '0049+8928924550'}], 'facility': 'Technical University of Munich', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}], 'centralContacts': [{'name': 'Philipp Gulde Gulde, Dr. phil.', 'role': 'CONTACT', 'email': 'philipp.gulde@tum.de', 'phone': '0049+8928924551'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Technical University of Munich', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}