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NCT Number: NCT06389968

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

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Technical University of Munich

Munich, Bavaria, 81675, Germany

Location status: Recruiting

Location contact

Philipp Gulde Gulde, Dr. phil.

CONTACT

[email protected]

0049+8928924550

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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, ...)

Treatment and study plan

Light stimulation

Device

see arm description

Sham light stimulation

Device

see arm description

Primary outcomes

  1. High contrast visual sensitivity

    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)

    Visual resolution with Sloan chart

Secondary outcomes

  1. Low contrast visual sensitivity

    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)

    Sloan chart at 2.5%

  2. Visually evoked potentials

    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)

    Visually evoked potential

  3. 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)

    Optical coherence tomography

  4. 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)

    Optical coherence tomographic angiography

  5. Color contrast

    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)

    Color contrast threshold (3 colors)

Study contacts

Contact information is provided by the study sponsor or research team.

Philipp Gulde Gulde, Dr. phil.

CONTACT

[email protected]

0049+8928924551

Sponsors and collaborators

Lead sponsor

Technical University of Munich

Other

Registry information

Official study title

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

Acronym: ONSTIM

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 29, 2024
Registry last updated
Nov 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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