Multiple Sclerosis, Relapsing-Remitting, Optic Neuritis
Conditions
Brief summary
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.
Interventions
DEVICELight stimulation
see arm description
DEVICESham light stimulation
see arm description
Sponsors
Technical University of Munich
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Intervention model description
sham-controlled
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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, ...)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| High contrast visual sensitivity | before intervention, directly after the first stimulation, after 12 days of training (stimulation) as 24 hour retention, and at 22 days post-intervention (retention) | Visual resolution with Sloan chart |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Low contrast visual sensitivity | before intervention, directly after the first stimulation, after 12 days of training (stimulation) as 24 hour retention, and at 22 days post-intervention (retention) | Sloan chart at 2.5% |
| Visually evoked potentials | 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 potential |
| 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) | Optical coherence tomography |
| 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) | Optical coherence tomographic angiography |
| Color contrast | 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 threshold (3 colors) |
Countries
Germany
Contacts
Primary ContactPhilipp Gulde Gulde, Dr. phil.
Outcome results
None listed