Transcranial Magnetic Stimulation for Visual Snow

(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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of repetitive transcranial magnetic stimulation (rTMS) for individuals with Visual Snow syndrome. Visual Snow syndrome causes constant static or "snow" in one's vision. Participants will undergo rTMS treatment five times a week for two weeks to determine if it reduces symptoms. Individuals with continuous Visual Snow for over three months and a recent clear MRI (brain scan) may qualify for this study. As an unphased trial, this study provides a unique opportunity to contribute to understanding and potentially improving treatment for Visual Snow syndrome.

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 prior data suggests that repetitive transcranial magnetic stimulation (rTMS) is safe for treating symptoms associated with Visual Snow syndrome?

Research has shown that repetitive transcranial magnetic stimulation (rTMS) is generally safe and well-tolerated. Some studies indicate that common side effects might include mild headaches or scalp discomfort, which usually resolve on their own.

The FDA provides guidelines for using rTMS, supporting its safety in treating various conditions. This offers reassurance about its safety for new uses like Visual Snow Syndrome. While rTMS can influence brain activity, expert guidelines suggest it is safe when used properly.

In short, evidence suggests that rTMS is safe for most people, with only minor side effects reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using Repetitive Transcranial Magnetic Stimulation (rTMS) for Visual Snow Syndrome because it offers a unique approach by directly targeting brain activity. Unlike current treatments that focus on managing symptoms with medications, rTMS uses magnetic pulses to potentially alter the brain's function in areas thought to be related to visual disturbances. This non-invasive method could provide relief without the side effects associated with drug therapies, offering a new hope for those suffering from this challenging condition.

What evidence suggests that repetitive transcranial magnetic stimulation (rTMS) might be an effective treatment for Visual Snow syndrome?

Research has shown that repetitive transcranial magnetic stimulation (rTMS), the treatment under study in this trial, could help treat various conditions. This treatment uses magnetic fields to stimulate brain cells. Studies have found that rTMS is particularly effective for depression, with 30-60% of people responding to the treatment. Specifically, about 36% of those receiving active treatment experience remission, compared to 8% in control groups. While rTMS is mainly used for depression, it might also help with symptoms of Visual Snow syndrome by targeting brain activity. Early signs are encouraging, but more research is needed to confirm its effectiveness for Visual Snow. ^{6 7 8 9 10}

Who Is on the Research Team?

Principal Investigator

Principal Investigator

CU School of Medicine

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Repetitive Transcranial Magnetic Stimulation (rTMS)

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12224075/

Resource utilization and economic outcomes following ...

In multiple studies, TMS has been shown to be more effective and less costly than serial pharmacotherapy trials or ECT [14–17]. TMS also ...

2.

sciencedirect.com

sciencedirect.com/science/article/pii/S2667174325001727

Efficacy, effectiveness and safety of transcranial magnetic ...

TMS is efficacious and safe in BDep, with response and remission rates on par with unipolar depression. High and low frequency protocols on left ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10375664/

Efficacy of repetitive transcranial magnetic stimulation ...

Data on remission rates were available from 9 studies. The overall remission rate was 35.71% (120/336) in the active rTMS group and 8.37% (18/ ...

4.

uclahealth.org

uclahealth.org/news/release/study-finds-possible-early-predictor-successful-transcranial

Study finds possible early predictor of successful ...

The effectiveness of rTMS has previously been observed as quite variable, with reported response rates ranging from 30-60%. Researchers at UCLA ...

5.

jamanetwork.com

jamanetwork.com/journals/jamanetworkopen/fullarticle/2835319

Repetitive Transcranial Magnetic Stimulation as ...

This randomized clinical trial compares the effectiveness between repetitive transcranial magnetic stimulation and lithium in preventing relapse

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9094636/

Safety and recommendations for TMS use in healthy subjects ...

Safety and recommendations for TMS use in healthy subjects and patient populations, with updates on training, ethical and regulatory issues: Expert Guidelines

7.

fda.gov

fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/repetitive-transcranial-magnetic-stimulation-rtms-systems-class-ii-special-controls-guidance

Repetitive Transcranial Magnetic Stimulation (rTMS) Systems

This guidance document was developed as a special controls guidance to support the classification of Repetitive Transcranial Magnetic Stimulation (r TMS) ...

8.

mayoclinic.org

mayoclinic.org/tests-procedures/transcranial-magnetic-stimulation/about/pac-20384625

Transcranial magnetic stimulation

Generally, rTMS is considered safe and well-tolerated. However, it can cause some side effects. Common side effects. Side effects are generally ...

9.

cms.gov

cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=36469&ver=24

LCD - Transcranial Magnetic Stimulation (TMS) (L36469)

Twenty-five received TMS and 27 sham and they report higher remission with active treatment than sham of 40% versus 14.8% concluding high dose deep TMS is safe ...

10.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0168559797000968

Risk and safety of repetitive transcranial magnetic stimulation

Repetitive TMS (rTMS), however, is a more powerful and potentially dangerous modality, capable of regionally blocking or facilitating cortical processes.