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

NCT ID: NCT06389968

Last Updated: 2024-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-01

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Multiple Sclerosis, Relapsing-Remitting Optic Neuritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

sham-controlled
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Light stimulation

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

Group Type EXPERIMENTAL

Light stimulation

Intervention Type DEVICE

see arm description

Sham light stimulation

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

Group Type SHAM_COMPARATOR

Sham light stimulation

Intervention Type DEVICE

see arm description

Interventions

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Light stimulation

see arm description

Intervention Type DEVICE

Sham light stimulation

see arm description

Intervention Type DEVICE

Eligibility Criteria

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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, ...)
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Technical University of Munich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Technical University of Munich

Munich, Bavaria, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Philipp Gulde Gulde, Dr. phil.

Role: CONTACT

0049+8928924551

Facility Contacts

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Philipp Gulde Gulde, Dr. phil.

Role: primary

0049+8928924550

Other Identifiers

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2023-491-S-KH

Identifier Type: -

Identifier Source: org_study_id

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