Multiple Sclerosis, Relapsing-Remitting Clinical Trial
— ONSTIMOfficial title:
Lichtstimulation Zur Verbesserung Der Sehleistung Bei Patientinnen Und Patienten Mit Multipler Sklerose Nach Sehnerventzündung
Verified date | April 2024 |
Source | Technical University of Munich |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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. In 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.
Status | Not yet recruiting |
Enrollment | 50 |
Est. completion date | December 31, 2025 |
Est. primary completion date | December 31, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | Inclusion Criteria: - Relapsing remitting multiple sclerosis or clinically isolated syndrome or no indication of chronic inflammatory central nervous system disease - Age 18-60 years - Optic neuritis within 1-3 months Exclusion Criteria: - Epilepsy - Light-triggered migraine - Insufficient vision correction - Retinal disease (glaucoma, macular edema, macula degeneration, ...) |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Technical University of Munich |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | High contrast visual sensitivity | Visual resolution with Sloan chart | before intervention, directly after the first stimulation, after 12 days of training (stimulation) as 24 hour retention, and at 22 days post-intervention (retention) | |
Secondary | Low contrast visual sensitivity | Sloan chart at 2.5% | before intervention, directly after the first stimulation, after 12 days of training (stimulation) as 24 hour retention, and at 22 days post-intervention (retention) | |
Secondary | Visually evoked potentials | Visually evoked potential | before intervention, directly after the first stimulation, after 12 days of training (stimulation) as 24 hour retention, and at 22 days post-intervention (retention) | |
Secondary | Optical coherence tomography | Optical coherence tomography | before intervention, directly after the first stimulation, after 12 days of training (stimulation) as 24 hour retention, and at 22 days post-intervention (retention) | |
Secondary | Optical coherence tomographic angiography | Optical coherence tomographic angiography | before intervention, directly after the first stimulation, after 12 days of training (stimulation) as 24 hour retention, and at 22 days post-intervention (retention) | |
Secondary | Color contrast | Color contrast threshold (3 colors) | before intervention, directly after the first stimulation, after 12 days of training (stimulation) as 24 hour retention, and at 22 days post-intervention (retention) |
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