Transcranial Magnetic Stimulation For Visual Snow Syndrome

(TMSVS Trial)

Overseen By Visual Snow Study Coordinator

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Disqualifiers: Epilepsy, Pregnancy, Bipolar, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 10

Duration: 2 weeks

10 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes those on medications that increase the risk of seizures.

What data supports the effectiveness of the treatment Repetitive Transcranial Magnetic Stimulation (rTMS)?

Research shows that repetitive transcranial magnetic stimulation (rTMS) can help improve motor function in stroke patients and reduce chronic pain. It is also being explored as a treatment for depression and other neuropsychiatric disorders, showing promise in these areas. ^{1 2 3 4 5}

How does the treatment rTMS differ from other treatments for this condition?

Repetitive Transcranial Magnetic Stimulation (rTMS) is unique because it is a non-invasive and painless method that uses magnetic fields to stimulate specific areas of the brain, potentially altering brain activity and improving symptoms. Unlike medications, it directly targets brain regions and can be used for conditions like depression and movement disorders, offering an alternative for patients who may not respond to traditional treatments. ^{4 6 7 8 9}

What is the purpose of this trial?

This trial investigates if a non-invasive brain stimulation technique can help people with Visual Snow syndrome. The treatment uses magnetic fields to stimulate specific brain areas, potentially improving symptoms. This technique has been explored for various neurological and psychiatric conditions, including depression, migraine, and anxiety disorders.

Research Team

Principal Investigator

Principal Investigator

CU School of Medicine

Eligibility Criteria

Inclusion Criteria

A diagnosis of VS that meets International Headache Society criteria

Able to provide meaningful informed consent

Visual snow must be present for more than three months and must be persistent (i.e. continuous)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive repetitive transcranial magnetic stimulation (rTMS) for 2 weeks, with 10 sessions administered 5 times a week

2 weeks

10 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with outcome measures assessed at Month 3

3 months

Treatment Details

Interventions

• Repetitive Transcranial Magnetic Stimulation (rTMS)

Participant Groups

Group I: One group Experimental Treatment 1 Intervention

All participants will undergo 2 weeks (5 times each week) of repetitive TMS

Repetitive Transcranial Magnetic Stimulation (rTMS) is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as rTMS for:

• Depression
• Smoking cessation

Approved in European Union as rTMS for:

• Depression

Approved in Canada as rTMS for:

• Depression

Approved in Japan as rTMS for:

• Depression

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

Findings from Research

Repetitive transcranial magnetic stimulation (rTMS) shows promising therapeutic efficacy, particularly in relieving chronic pain and aiding motor neurorehabilitation in stroke patients, based on a review of 32 randomized controlled trials.

While rTMS may also improve motor function in Parkinson's disease and reduce seizure frequency in epilepsy, the evidence is less robust and requires further long-term studies to confirm these effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial magnetic stimulation in neurology: what we have learned from randomized controlled studies. Hemond, CC., Fregni, F.[2022]

Suprathreshold rTMS over the left primary sensorimotor cortex significantly increased brain activity in the stimulated area and supplementary motor area (SMA) in most subjects, indicating effective neuronal activation.

Subthreshold rTMS did not activate the primary sensorimotor cortex but still modulated activity in remote areas like the SMA and lateral premotor cortex, suggesting it influences corticocortical connections without inducing motor responses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Subthreshold high-frequency TMS of human primary motor cortex modulates interconnected frontal motor areas as detected by interleaved fMRI-TMS. Bestmann, S., Baudewig, J., Siebner, HR., et al.[2019]

Repetitive magnetic stimulation (rTMS) is a non-invasive and painless technique that can effectively activate specific areas of the brain, making it useful for studying language, memory, and visual perception.

rTMS shows potential therapeutic benefits for conditions like movement disorders and depression, but there are safety considerations regarding its potential to induce seizures, which are addressed in the study.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Repetitive transcranial magnetic stimulation. Possibilities, limits and safety aspects]. Brandt, SA., Ploner, CJ., Meyer, BU.[2019]

References

1. England pubmed.ncbi.nlm.nih.gov

Magnetic stimulation and movement-related cortical activity for acute stroke with hemiparesis. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Transcranial magnetic stimulation in neurology: what we have learned from randomized controlled studies. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Transcranial magnetic stimulation: a device intended for the psychiatrist's office, but what is its future clinical role? [2008]

4. United States pubmed.ncbi.nlm.nih.gov

Effect of high-frequency repetitive transcranial magnetic stimulation on brain excitability in severely brain-injured patients in minimally conscious or vegetative state. [2022]

5. England pubmed.ncbi.nlm.nih.gov

rTMS of the prefrontal cortex has analgesic effects on neuropathic pain in subjects with spinal cord injury. [2018]

6. Germany pubmed.ncbi.nlm.nih.gov

Direct demonstration of the effects of repetitive transcranial magnetic stimulation on the excitability of the human motor cortex. [2015]

7. United States pubmed.ncbi.nlm.nih.gov

Subthreshold high-frequency TMS of human primary motor cortex modulates interconnected frontal motor areas as detected by interleaved fMRI-TMS. [2019]

8. Germany pubmed.ncbi.nlm.nih.gov

[Repetitive transcranial magnetic stimulation. Possibilities, limits and safety aspects]. [2019]

9. Germany pubmed.ncbi.nlm.nih.gov

Effects of repetitive cortical stimulation on the silent period evoked by magnetic stimulation. [2019]