Light Stimulation to Improve Visual Function After Optic Neuritis in Persons with Multiple Sclerosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorTechnical University of Munich
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Epilepsy
Light-triggered migraine
Insufficient vision correction
Retinal disease (glaucoma, macular edema, macula degeneration, ...)
Trial design
Design model
Parallel
Treatments tested in this trial
Light stimulation
Devicesee arm description
Sham light stimulation
Devicesee arm description
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Light stimulationExperimental treatment 1 intervention
Group B: Sham light stimulationSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
High contrast visual sensitivity
Visual resolution with Sloan chart
Time frame
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
1
Low contrast visual sensitivity
Sloan chart at 2.5%
Time frame
before intervention, directly after the first stimulation, after 12 days of training (stimulation) as 24 hour retention, and at 22 days post-intervention (retention)2
Visually evoked potentials
Visually evoked potential
Time frame
before intervention, directly after the first stimulation, after 12 days of training (stimulation) as 24 hour retention, and at 22 days post-intervention (retention)3
Optical coherence tomography
Optical coherence tomography
Time frame
before intervention, directly after the first stimulation, after 12 days of training (stimulation) as 24 hour retention, and at 22 days post-intervention (retention)4
Optical coherence tomographic angiography
Optical coherence tomographic angiography
Time frame
before intervention, directly after the first stimulation, after 12 days of training (stimulation) as 24 hour retention, and at 22 days post-intervention (retention)Sponsors and contacts
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Source ClinicalTrials.gov