protocolSection identificationModule nctId: NCT06389968, orgStudyIdInfo id: 2023-491-S-KH, briefTitle: Light Stimulation to Improve Visual Function After Optic Neuritis in Persons With Multiple Sclerosis, acronym: ONSTIM, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-02, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Technical University of Munich, class: OTHER, descriptionModule briefSummary: The aim of this monocentric randomized controlled intervention study is to improve visual function in persons with multiple sclerosis (pwMS) following optic neuritis (neuritis nervi optici, NNO) 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 pwMS following recent NNO (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 (n=25), the spontaneous course after NNO 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 (LCVA), the P100 conduction latency of visual evoked potentials, and retinal layer thicknesses and vessel densities measured in optical coherence tomography (OCT) and OCT angiography (OCTA). These physiological parameters should help to understand the underlying processes of a potentially altered visual performance., conditionsModule conditions: Multiple Sclerosis, Relapsing-Remitting, conditions: Optic Neuritis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: sham-controlled, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Light stimulation, interventions name: Sham light stimulation, outcomesModule primaryOutcomes measure: High contrast visual sensitivity, secondaryOutcomes measure: Low contrast visual sensitivity, secondaryOutcomes measure: VEP, secondaryOutcomes measure: OCT, secondaryOutcomes measure: OCT Angiography, secondaryOutcomes measure: Color contrast, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, hasResults: False