Light Stimulation to Improve Visual Function After Optic Neuritis in Persons with Multiple Sclerosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Light stimulation, Sham light stimulation.
- Who it may be relevant to
- Registry conditions: Multiple Sclerosis, Relapsing-Remitting, Optic Neuritis. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Lichtstimulation Zur Verbesserung Der Sehleistung Bei Patientinnen Und Patienten Mit Multipler Sklerose Nach Sehnerventzündung
Overview
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
- Device Light stimulation
see arm description - Device Sham light stimulation
see arm description
Primary outcome measures
- High contrast visual sensitivity [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)]
Secondary outcome measures (5)
- Low contrast visual sensitivity [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 [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 [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 [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 [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)]
Eligibility criteria
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, ...)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Basic science
Study locations
Germany · 1 center
- Technical University of Munich — Munich
Identifiers
NCT: NCT06389968 · 2023-491-S-KH