NCT06389968 Light Stimulation to Improve Visual Function After Optic Neuritis in Persons with Multiple Sclerosis
| NCT ID | NCT06389968 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Technical University of Munich |
| Condition | Multiple Sclerosis, Relapsing-Remitting |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2024-08-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2024-08-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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, ...)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06389968 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Multiple Sclerosis, Relapsing-Remitting. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06389968 currently recruiting?
Yes, NCT06389968 is actively recruiting participants. Contact the research team at philipp.gulde@tum.de for enrollment information.
Where is the NCT06389968 trial being conducted?
This trial is being conducted at Munich, Germany.
Who is sponsoring the NCT06389968 clinical trial?
NCT06389968 is sponsored by Technical University of Munich. The trial plans to enroll 50 participants.
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