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

NCT06389968 | Recruiting

• 1 other identifier: 2023-491-S-KH
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis, Relapsing-Remitting; Optic Neuritis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Low contrast visual sensitivity

  before intervention, directly after the first stimulation, after 12 days of training (stimulation) as 24 hour retention, and at 22 days post-intervention (retention)

• Visually evoked potentials

  before intervention, directly after the first stimulation, after 12 days of training (stimulation) as 24 hour retention, and at 22 days post-intervention (retention)

• 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)

• 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)

• Color contrast

  before intervention, directly after the first stimulation, after 12 days of training (stimulation) as 24 hour retention, and at 22 days post-intervention (retention)

Study Arms (2)

Light stimulation

EXPERIMENTAL

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

Device: Light stimulation

Sham light stimulation

SHAM COMPARATOR

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

Device: Sham light stimulation

Interventions

Light stimulation DEVICE

see arm description

Light stimulation

Sham light stimulation DEVICE

see arm description

Sham light stimulation

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Epilepsy
• Light-triggered migraine
• Insufficient vision correction
• Retinal disease (glaucoma, macular edema, macula degeneration, ...)

Sponsors & Collaborators

• Technical University of Munich: lead

Study Sites (1)

Technical University of Munich

Munich, Bavaria, 81675, Germany

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting; Optic Neuritis

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Optic Nerve Diseases; Cranial Nerve Diseases; Eye Diseases

Central Study Contacts

Philipp Gulde Gulde, Dr. phil.

CONTACT

0049+8928924551; philipp.gulde@tum.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: sham-controlled

Study Record Dates

• First Submitted: April 22, 2024
• First Posted: April 29, 2024
• Study Start: August 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 22, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)