TMS for Epilepsy

Overseen By Benjamin Pace

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Aaron Boes

Disqualifiers: Neurological, psychiatric disorders, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6-8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how transcranial magnetic stimulation (TMS), a type of non-invasive brain stimulation, affects the brain in people with epilepsy. The goal is to observe changes in brain activity caused by TMS, tracked by special sensors placed inside the skull. The trial includes both real and placebo (inactive) stimulation to better understand its effects. Suitable participants are those undergoing brain surgery for epilepsy who already have sensors in their brains to aid in treatment planning. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could enhance future epilepsy treatments.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that transcranial magnetic stimulation (TMS) is safe for neurosurgical patients?

Research has shown that transcranial magnetic stimulation (TMS) is generally safe, even for people with epilepsy. Studies have found that the chance of a seizure from TMS is less than 1%, making it a low-risk option. Other side effects are similar to those of other treatments, with nothing unusual reported. TMS has been safely used in individuals with epilepsy and other brain conditions. Overall, most people tolerate the treatment well. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Transcranial Magnetic Stimulation (TMS) for epilepsy because it offers a non-invasive way to potentially modulate brain activity. Unlike standard treatments like anti-seizure medications, which often have systemic side effects, TMS targets specific areas of the brain using magnetic fields, which can reduce side effects and improve quality of life. Additionally, TMS provides a new avenue for understanding brain function in real-time, offering insights that could lead to more personalized epilepsy care in the future.

What evidence suggests that TMS is effective for epilepsy?

Research has shown that transcranial magnetic stimulation (TMS) can help people with epilepsy. One study found that low-frequency TMS reduced seizures by 30% in individuals with difficult-to-treat epilepsy. Other studies have also reported fewer seizures and less abnormal brain activity, suggesting that TMS helps calm the brain. In this trial, participants will receive both active and sham TMS stimulation at varying points. Previous research indicates that in active TMS treatments, half of the participants experienced a significant drop in seizures compared to those who received a sham treatment. This evidence suggests that TMS might be a promising option for reducing seizures in people with epilepsy. ^{2 4 6 7 8}

Who Is on the Research Team?

Aaron Boes, MD, PhD

Principal Investigator

University of Iowa

Are You a Good Fit for This Trial?

This trial is for adults over 18 who are neurosurgery patients with intracranial electrodes implanted, undergoing long-term EEG monitoring for epilepsy surgery candidacy. Participants must understand the study's risks and benefits to give consent. Those with neurological or psychiatric conditions besides their primary disease are excluded.

Inclusion Criteria

I understand the study's risks and benefits and can consent.

I will undergo a 2-week EEG to see if I'm a candidate for epilepsy surgery.

I am over 18 and have had brain surgery to implant electrodes.

Exclusion Criteria

I do not have any neurological or psychiatric disorders unrelated to my primary condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive transcranial magnetic stimulation (TMS) with intracranial EEG monitoring to assess brain responses

6-8 weeks

Multiple sessions with both active and sham stimulation

Follow-up

Participants are monitored for safety and effectiveness after TMS treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• TMS

Trial Overview The study examines how transcranial magnetic stimulation (TMS), a non-invasive brain stimulation method, affects brain activity as recorded by intracranial electroencephalography in patients preparing for epilepsy surgery.

How Is the Trial Designed?

Group I: TMS in patients with intracranial electrodes Experimental Treatment 1 Intervention

We will administer TMS to neurosurgical patients with intracranial electroencephalography in order to better understand the effects TMS has on the human brain. Participants will receive both active and sham stimulation at varying points during the study.

TMS is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Transcranial Magnetic Stimulation for:

• Depression
• Anxiety disorders
• Post-traumatic stress disorder (PTSD)
• Obsessive-compulsive disorder (OCD)

Approved in European Union as Transcranial Magnetic Stimulation for:

• Depression
• Anxiety disorders
• Post-traumatic stress disorder (PTSD)
• Obsessive-compulsive disorder (OCD)

Approved in Canada as Transcranial Magnetic Stimulation for:

• Depression
• Anxiety disorders
• Post-traumatic stress disorder (PTSD)
• Obsessive-compulsive disorder (OCD)

Who Is Running the Clinical Trial?

Aaron Boes

Lead Sponsor

Trials

2

Recruited

20+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Stanford University

Collaborator

Trials

2,527

Recruited

17,430,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5839309/

Repetitive transcranial magnetic stimulation for the treatment ... We identified a 30% reduction in seizure frequency following low‐frequency rTMS for the treatment of refractory epilepsy. This effect closely agrees with a ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9881833/

Literature Review of the Efficacy of Repetitive Transcranial ... Numerous studies on the effect of rTMS on epileptic patients have reported a reduction in the seizures frequency and/or epileptic discharges (26) (27) (28) (29) ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0920121123002024

Time-effectiveness of low-frequency rTMS for epilepsy and ... The current evidence suggests that low-frequency rTMS-assisted therapy significantly improves antiepileptics drugs' efficacy and improves patients' cognitive ...

4. seizure-journal.com seizure-journal.com/article/S1059-1311(25)00187-6/fulltext

A crossover, randomized, single-blinded, sham-controlled ... Active rTMS showed a 50 % responder rate and 16.7 % seizure freedom compared to sham stimulation. •. Seizure reduction was most prominent in the ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S1094715925000303

Repetitive Transcranial Magnetic Stimulation for Refractory ... rTMS caused cessation in 75.8% of patients with (S)RSE within four days, with recurrence in 47%. To determine the therapeutic potential of rTMS ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/26970993/

Safety of repetitive transcranial magnetic stimulation in ... We conclude that the risk of seizure induction in patients with epilepsy undergoing rTMS is small and that the risk of other adverse events is similar.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7732158/

Transcranial Magnetic Stimulation (TMS) Safety with ... The risk of TMS-related seizures is <1% overall. TMS has successfully been used in patients with epilepsy, traumatic brain injuries, and those ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S1935861X21001182

Seizure risk with repetitive TMS: Survey results from over a ... The absolute risk of a seizure with rTMS is low, but generic Brainsway H-coil treatment appears to be associated with a higher relative risk than generic ...