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Clinical Trials in Germany / NCT06389968
Recruiting Not applicable

Light Stimulation to Improve Visual Function After Optic Neuritis in Persons with Multiple Sclerosis

NCT06389968 · tracked via the Priya Life Science Germany tracker
Phase
Not applicable
Started
2024-08-01
Last updated
2024-11-22

Condition(s) studied

Multiple Sclerosis, Relapsing-RemittingOptic Neuritis

Investigational drug(s) / intervention(s)

Light stimulationSham light stimulation

Light stimulation: see arm description

Sham light stimulation: see arm description

Study 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

Sex
ALL
Min age
18 Years
Max age
60 Years
Healthy volunteers
Accepted
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, ...)

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Technical University of Munich Munich Bavaria Recruiting

More Technical University of Munich trials in Germany

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06389968 on ClinicalTrials.gov ↗ ← All trials in Germany