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

Technical University of Munich

Status: Enrolling

Conditions: Multiple Sclerosis, Relapsing-Remitting; Optic Neuritis

Treatments: Device: Sham light stimulation; Device: Light stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06389968

2023-491-S-KH

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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, ...)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Light stimulation

Experimental group

Description:

Experimental light stimulation (3 colors at 20 Hertz each for 80 seconds twice a day).

Treatment:

Device: Light stimulation

Sham light stimulation

Sham Comparator group

Description:

Sham light stimulation (white screen for 80 seconds twice a day).

Treatment:

Device: Sham light stimulation