Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06389968
Other study ID # 2023-491-S-KH
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date May 2, 2024
Est. completion date December 31, 2025

Study information

Verified date April 2024
Source Technical University of Munich
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 50
Est. completion date December 31, 2025
Est. primary completion date December 31, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility 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, ...)

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Light stimulation
see arm description
Sham light stimulation
see arm description

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Technical University of Munich

Outcome

Type Measure Description Time frame Safety issue
Primary High contrast visual sensitivity Visual resolution with Sloan chart 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 Low contrast visual sensitivity Sloan chart at 2.5% 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 Visually evoked potentials Visually evoked potential 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 Optical coherence tomography Optical coherence tomography 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 Optical coherence tomographic angiography Optical coherence tomographic angiography 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 Color contrast Color contrast threshold (3 colors) before intervention, directly after the first stimulation, after 12 days of training (stimulation) as 24 hour retention, and at 22 days post-intervention (retention)
See also
  Status Clinical Trial Phase
Completed NCT02861014 - A Study of Ocrelizumab in Participants With Relapsing Remitting Multiple Sclerosis (RRMS) Who Have Had a Suboptimal Response to an Adequate Course of Disease-Modifying Treatment (DMT) Phase 3
Terminated NCT01435993 - Multiple Doses of Anti-NOGO A in Relapsing Forms of Multiple Sclerosis Phase 1
Recruiting NCT05964829 - Impact of the Cionic Neural Sleeve on Mobility in Multiple Sclerosis N/A
Completed NCT03653585 - Cortical Lesions in Patients With Multiple Sclerosis
Completed NCT02410200 - Study of the Effect of BG00012 on MRI Lesions and Pharmacokinetics in Pediatric Subjects With RRMS Phase 2
Completed NCT03975413 - Fecal Microbiota Transplantation (FMT) in Multiple Sclerosis
Completed NCT05080270 - Feasibility Study of Tolerogenic Fibroblasts in Patients With Refractory Multiple Sclerosis Early Phase 1
Completed NCT01116427 - A Cooperative Clinical Study of Abatacept in Multiple Sclerosis Phase 2
Completed NCT01108887 - An Observational Study for the Assessment of Adherence, Effectiveness and Convenience of Rebif® Treatment in Relapsing Multiple Sclerosis Patients Using RebiSmartâ„¢. N/A
Completed NCT01141751 - An Observational Study Comparing Multiple Sclerosis International Quality of Life Questionnaire (MusiQoL) and Multiple Sclerosis Quality of Life-54 Instrument (MSQOL-54) in Relapsing Multiple Sclerosis (RMS) Patients on Long-term Rebif® Therapy N/A
Completed NCT00097331 - Three Months Treatment With SB683699 In Patients With Relapsing Multiple Sclerosis Phase 2
Completed NCT01909492 - Measurement of Relaxin Peptide in Multiple Sclerosis (MS)
Completed NCT04121221 - A Study to Asses Efficacy, Safety and Tolerability of Monthly Long-acting IM Injection of GA Depot in Subjects With RMS Phase 3
Withdrawn NCT04880577 - Tenofovir Alafenamide for Treatment of Symptoms and Neuroprotection in Relapsing Remitting Multiple Sclerosis Phase 2
Not yet recruiting NCT05290688 - Cellular microRNA Signatures in Multiple Sclerosis N/A
Completed NCT04528121 - Effect of CoDuSe Balance Training and Step Square Exercises on Risk of Fall in Multiple Sclerosis N/A
Recruiting NCT04002934 - Bazedoxifene Acetate as a Remyelinating Agent in Multiple Sclerosis Phase 2
Recruiting NCT05019248 - Immune Response to Seasonal Influenza Vaccination in Multiple Sclerosis Patients Receiving Cladribine
Completed NCT04580381 - Real World Effectiveness of Natalizumab Extended Interval Dosing in a French Cohort
Completed NCT00071838 - Zenapax (Daclizumab) to Treat Relapsing Remitting Multiple Sclerosis Phase 2