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

Multiple Sclerosis, Relapsing-Remitting Clinical Trial

— ONSTIM  

Official title:

Lichtstimulation Zur Verbesserung Der Sehleistung Bei Patientinnen Und Patienten Mit Multipler Sklerose Nach Sehnerventzündung

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06389968
• Other study ID #: 2023-491-S-KH
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2024
• Source: Technical University of Munich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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, ...)

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Neuritis
• Optic Neuritis
• Sclerosis

Intervention

Device:
• Light stimulation
see arm description
• Sham light stimulation
see arm description

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Technical University of Munich

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	High contrast visual sensitivity	Visual resolution with Sloan chart	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	Low contrast visual sensitivity	Sloan chart at 2.5%	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	Visually evoked potentials	Visually evoked potential	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	Optical coherence tomography	Optical coherence tomography	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	Optical coherence tomographic angiography	Optical coherence tomographic angiography	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	Color contrast	Color contrast threshold (3 colors)	before intervention, directly after the first stimulation, after 12 days of training (stimulation) as 24 hour retention, and at 22 days post-intervention (retention)