An interventional study of Light stimulation and Sham light stimulation in Multiple Sclerosis, Relapsing-Remitting and Optic Neuritis, sponsored by Technical University of Munich. Recruiting at 1 site in Germany. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-22.
Sponsored by Technical University of Munich · Not applicable, Interventional, and Basic science
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.
618 studies on the registry are indexed under Multiple Sclerosis, Relapsing-Remitting; 82 are open to participants now.
This study's planned enrollment of 50 is below the median of 66 across 437 interventional studies indexed under Multiple Sclerosis, Relapsing-Remitting.
Browse Multiple Sclerosis, Relapsing-Remitting studies →Technical University of Munich is the lead sponsor of 320 studies on the registry; 58 are open to participants now.
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Exclusion Criteria:
Experimental light stimulation (3 colors at 20 Hertz each for 80 seconds twice a day).
Device: Light stimulation
Sham light stimulation (white screen for 80 seconds twice a day).
Device: Sham light stimulation
see arm description
see arm description
High contrast visual sensitivity
Visual resolution with Sloan chart
Time frame: before intervention, directly after the first stimulation, after 12 days of training (stimulation) as 24 hour retention, and at 22 days post-intervention (retention)
Low contrast visual sensitivity
Sloan chart at 2.5%
Time frame: before intervention, directly after the first stimulation, after 12 days of training (stimulation) as 24 hour retention, and at 22 days post-intervention (retention)
Visually evoked potentials
Visually evoked potential
Time frame: before intervention, directly after the first stimulation, after 12 days of training (stimulation) as 24 hour retention, and at 22 days post-intervention (retention)
Optical coherence tomography
Optical coherence tomography
Time frame: before intervention, directly after the first stimulation, after 12 days of training (stimulation) as 24 hour retention, and at 22 days post-intervention (retention)
Optical coherence tomographic angiography
Optical coherence tomographic angiography
Time frame: before intervention, directly after the first stimulation, after 12 days of training (stimulation) as 24 hour retention, and at 22 days post-intervention (retention)
Color contrast
Color contrast threshold (3 colors)
Time frame: before intervention, directly after the first stimulation, after 12 days of training (stimulation) as 24 hour retention, and at 22 days post-intervention (retention)
Plan to share: No
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