Multiple Sclerosis, Relapsing-RemittingONSTIMNCT06389968
Light Stimulation to Improve Visual Function After Optic Neuritis in Persons with Multiple Sclerosis
A study testing Light stimulation in people with Multiple Sclerosis, Relapsing-Remitting and Optic Neuritis, run by Technical University of Munich at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis, Relapsing-Remitting, Optic Neuritis
- What is being tested?
- Light stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- 1 Aug 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Epilepsy
- Light-triggered migraine
- Insufficient vision correction
- Retinal disease (glaucoma, macular edema, macula degeneration, ...)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Technical University of Munich
Munich, Bavaria, 81675
Philipp Gulde Gulde, Dr. phil., 0049+8928924550, philipp.gulde@tum.de
About this study
Official title: Lichtstimulation Zur Verbesserung Der Sehleistung Bei Patientinnen Und Patienten Mit Multipler Sklerose Nach Sehnerventzündung
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.
- Being tested
- Light stimulation, Sham light stimulation
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting, Optic Neuritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Light stimulationDevice
see arm description
Sham light stimulationDevice
see arm description
| Study group | Role | What they receive |
|---|---|---|
| Light stimulation | Experimental | Experimental light stimulation (3 colors at 20 Hertz each for 80 seconds twice a day). Receives: Device: Light stimulation |
| Sham light stimulation | Sham comparator | Sham light stimulation (white screen for 80 seconds twice a day). Receives: Device: Sham light stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
High contrast visual sensitivity
Visual resolution with Sloan chart
Measured: 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 (5)
Low contrast visual sensitivity
Sloan chart at 2.5%
Measured: 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 potentials
Visually evoked potential
Measured: 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
Optical coherence tomography
Measured: 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
Optical coherence tomographic angiography
Measured: 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
Color contrast threshold (3 colors)
Measured: before intervention, directly after the first stimulation, after 12 days of training (stimulation) as 24 hour retention, and at 22 days post-intervention (retention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2024
- Study start1 Aug 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Sclerosis, Relapsing-RemittingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- sham-controlled
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06389968
- Sponsor's protocol ID
- 2023-491-S-KH
- Acronym
- ONSTIM
- Status last verified
- Apr 2024
- First submitted
- 22 Apr 2024
- Last updated
- 22 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lichtstimulation Zur Verbesserung Der Sehleistung Bei Patientinnen Und Patienten Mit Multipler Sklerose Nach Sehnerventzündung
- ClinicalTrials.gov ID
- NCT06389968
- Acronym / sponsor ID
- ONSTIM / 2023-491-S-KH
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 29 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- sham-controlled
| Arm | Type | Receives |
|---|---|---|
| Light stimulation | Experimental | Device: Light stimulationExperimental light stimulation (3 colors at 20 Hertz each for 80 seconds twice a day). |
| Sham light stimulation | Sham comparator | Device: Sham light stimulationSham light stimulation (white screen for 80 seconds twice a day). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- Epilepsy
- Light-triggered migraine
- Insufficient vision correction
- Retinal disease (glaucoma, macular edema, macula degeneration, ...)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Light stimulationsee arm description | Device | Light stimulation |
| Sham light stimulationsee arm description | Device | Sham light stimulation |
Primary outcome
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
5 secondary outcomes
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)
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)
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 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)
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2024.
- Individual participant dataSharing planned: No
Related trials for Multiple Sclerosis, Relapsing-Remitting
Active, not recruiting
Tai Chi Training for Persons With Multiple Sclerosis.
Multiple Sclerosis (MS) - Relapsing-remitting
RecruitingPhase 2
The HIt HArd and hiT Early in Multiple Sclerosis Trial
Relapsing-remitting Multiple Sclerosis
RecruitingPhase 3
Best Available Therapy Versus Autologous Hematopoietic Stem Cell Transplant for Multiple Sclerosis (BEAT-MS)
Relapsing Multiple Sclerosis, Relapsing Remitting Multiple Sclerosis
RecruitingObservational study
Early Versus Delayed Start of Ocrevus Zunovo for Relapsing Multiple Sclerosis
Relapse Remitting Multiple Sclerosis
Not yet recruitingPhase 2
A Study to Evaluate Pharmacokinetics, Safety, Tolerability, Immunogenicity and Pharmacodynamic Effects of Subcutaneous Ocrelizumab Administration in Children and Adolescents With Relapsing-remitting Multiple Sclerosis (RRMS)
Relapsing-remitting Multiple Sclerosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Light stimulation in people with Multiple Sclerosis, Relapsing-Remitting and Optic Neuritis, run by Technical University of Munich at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Philipp Gulde Gulde, Dr. phil. (0049+8928924551, philipp.gulde@tum.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2024.