Clinical trial NCT06389968: Light Stimulation to Improve Visual Function After Optic Neuritis in Persons with Multiple Sclerosis
Official title: Lichtstimulation Zur Verbesserung Der Sehleistung Bei Patientinnen Und Patienten Mit Multipler Sklerose Nach Sehnerventzündung
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Multiple Sclerosis, Relapsing-Remitting
Optic Neuritis
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
First posted: 2024-04-29
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: sham-controlled
Primary purpose: BASIC_SCIENCE

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, ...)

Primary outcomes:
measure: High contrast visual sensitivity
timeFrame: 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 outcomes:
measure: Low contrast visual sensitivity
timeFrame: before intervention, directly after the first stimulation, after 12 days of training (stimulation) as 24 hour retention, and at 22 days post-intervention (retention)
measure: Visually evoked potentials
timeFrame: before intervention, directly after the first stimulation, after 12 days of training (stimulation) as 24 hour retention, and at 22 days post-intervention (retention)
measure: Optical coherence tomography
timeFrame: before intervention, directly after the first stimulation, after 12 days of training (stimulation) as 24 hour retention, and at 22 days post-intervention (retention)
measure: Optical coherence tomographic angiography
timeFrame: before intervention, directly after the first stimulation, after 12 days of training (stimulation) as 24 hour retention, and at 22 days post-intervention (retention)
measure: Color contrast
timeFrame: before intervention, directly after the first stimulation, after 12 days of training (stimulation) as 24 hour retention, and at 22 days post-intervention (retention)
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Technical University of Munich
state: Bavaria
Study officials:
References: