RecruitingNot ApplicableNCT06389968

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

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


Sponsor

Technical University of Munich

Enrollment

50 participants

Start Date

Aug 1, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 60 Years

Inclusion Criteria3

  • 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 Criteria4

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

Interventions

DEVICELight stimulation

see arm description

DEVICESham light stimulation

see arm description


Locations(1)

Technical University of Munich

Munich, Bavaria, Germany

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NCT06389968


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