Light Stimulation to Improve Visual Function After Optic Neuritis in Persons with Multiple Sclerosis
NCT ID: NCT06389968
Last Updated: 2024-11-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
50 participants
INTERVENTIONAL
2024-08-01
2026-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
SINGLE
Study Groups
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Light stimulation
Experimental light stimulation (3 colors at 20 Hertz each for 80 seconds twice a day).
Light stimulation
see arm description
Sham light stimulation
Sham light stimulation (white screen for 80 seconds twice a day).
Sham light stimulation
see arm description
Interventions
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Light stimulation
see arm description
Sham light stimulation
see arm description
Eligibility Criteria
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Inclusion Criteria
* Age 18-60 years
* Optic neuritis within 1-3 months
Exclusion Criteria
* Light-triggered migraine
* Insufficient vision correction
* Retinal disease (glaucoma, macular edema, macula degeneration, ...)
18 Years
60 Years
ALL
Yes
Sponsors
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Technical University of Munich
OTHER
Responsible Party
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Locations
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Technical University of Munich
Munich, Bavaria, Germany
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2023-491-S-KH
Identifier Type: -
Identifier Source: org_study_id
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