Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06389968
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-01
First Post:
2024-04-22
Brief Title:
Light Stimulation to Improve Visual Function After Optic Neuritis in Persons With Multiple Sclerosis
Sponsor:
Technical University of Munich
Organization:
Technical University of Munich
Study Overview
Official Title:
Lichtstimulation Zur Verbesserung Der Sehleistung Bei Patientinnen Und Patienten Mit Multipler Sklerose Nach Sehnerventzündung
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ONSTIM
Brief 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 25 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
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 25 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None