Actively Recruiting

Phase Not Applicable
Age: 18Years - 60Years
All Genders
Healthy Volunteers
NCT06389968

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

Led by Technical University of Munich · Updated on 2024-11-22

50

Participants Needed

1

Research Sites

126 weeks

Total Duration

On this page

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 60Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with relapsing remitting multiple sclerosis, clinically isolated syndrome, or no indication of chronic inflammatory central nervous system disease
  • Aged between 18 and 60 years
  • Experienced optic neuritis within the past 1 to 3 months
Not Eligible

You will not qualify if you...

  • History of epilepsy
  • Experience of light-triggered migraines
  • Insufficient vision correction
  • Presence of retinal diseases such as glaucoma, macular edema, or macular degeneration

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Technical University of Munich

Munich, Bavaria, Germany, 81675

Actively Recruiting

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Research Team

P

Philipp Gulde Gulde, Dr. phil.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

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