Transcranial Magnetic Stimulation for Nonepileptic Seizures

(FND-seiz Trial)

Overseen By Recruitment Coordinator

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Medical University of South Carolina

Must not be taking: Seizure-threshold-lowering drugs

Disqualifiers: Epilepsy, Psychosis, Substance use, others

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

Compensation: Varies

Number of Visits: 2

Duration: 3-5 days

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment method called accelerated TMS (Transcranial Magnetic Stimulation) for individuals with nonepileptic seizures, often referred to as Psychogenic Non-Epileptic Seizures (PNES). Researchers aim to determine the feasibility and effectiveness of this method by measuring seizure frequency and overall quality of life before and after treatment. The trial includes multiple TMS sessions over several days, targeting specific brain areas believed to alleviate FND-seizure symptoms. Suitable participants are those who have experienced documented nonepileptic seizures for more than three months, have them at least monthly, and are not currently undergoing psychotherapy. As an Early Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the chance to be among the first to receive this innovative approach.

Do I have to stop taking my current medications for the trial?

You can continue taking your current psychotropic medications during the study, but you must not change the doses or switch to different medications.

What prior data suggests that this protocol is safe for treating nonepileptic seizures?

Research has shown that transcranial magnetic stimulation (TMS) is generally safe, even for individuals with conditions like epilepsy. Studies have found that serious events, such as life-threatening seizures, do not occur with repetitive TMS (rTMS) treatments. Although seizures are a rare possibility with TMS, they remain uncommon. Other studies have used accelerated TMS, which is usually well-tolerated, indicating it is mostly safe for participants. This trial is in its early stages, so researchers are still collecting safety data. However, past research offers some reassurance about its safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for nonepileptic seizures, which typically involve medications or therapy to manage symptoms, Accelerated Transcranial Magnetic Stimulation (TMS) offers a non-invasive and drug-free alternative. Accelerated TMS is unique because it uses magnetic fields to stimulate nerve cells in the brain, potentially altering brain activity linked to these seizures. Researchers are excited about this approach because it might provide quicker relief, potentially showing effects in just a few days, compared to weeks or months with traditional treatments. Additionally, TMS focuses directly on brain function, offering a targeted approach that could reduce the need for prolonged medication use and its associated side effects.

What evidence suggests that this protocol is effective for nonepileptic seizures?

Research has shown that Transcranial Magnetic Stimulation (TMS) may reduce the number of seizures in individuals with non-epileptic seizures. In one study, patients experienced fewer seizures after TMS treatment. Another study found that 89% of participants improved with TMS. This trial will investigate the effects of Accelerated TMS, which uses magnetic fields to stimulate specific brain areas and may help control unusual brain activity that can cause seizures. Early results suggest that TMS is generally well-tolerated and could be a practical treatment option for those with functional neurologic disorders like PNES. ^{2 6 7 8 9}

Who Is on the Research Team?

Joseph Chasen, DO

Principal Investigator

Medical University of South Carolina

Are You a Good Fit for This Trial?

This trial is for individuals with Seizure-Type Functional Neurologic Disorders, such as Psychogenic Non-Epileptic Seizures. Participants should be able to undergo multiple Transcranial Magnetic Stimulation sessions over a few days. Specific eligibility criteria are not provided, but typically include being in stable health and meeting diagnostic criteria for the condition.

Inclusion Criteria

English speaking, able to read and write, and provide informed consent

I can keep taking my current mental health medications without changing them during the trial.

In good general health as per medical history

Exclusion Criteria

Participation in any clinical trial with an investigational drug or device within the past month

Ongoing psychosis, mania, active alcohol or substance use disorder

Active suicidal intent or HAM-D score >2 on question 3

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive 6-to-10 iTBS-rTMS sessions per day over 3-to-5 treatment days, targeting the left dorsolateral prefrontal cortex

3-5 days

Daily visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of seizure frequency and quality of life

4 weeks

1 visit (in-person)

Open-label extension (optional)

Participants may opt into continuation of treatment long-term if initial results are promising

What Are the Treatments Tested in This Trial?

Interventions

• Accelerated TMS

Trial Overview

The study tests an accelerated form of Transcranial Magnetic Stimulation (TMS) targeting the left prefrontal cortex to treat seizure-type disorders without epilepsy. Patients will receive numerous short TMS sessions daily for 3-5 days, aiming for a total of 30 sessions.

How Is the Trial Designed?

Group I: Interventional Arm Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials

994

Recruited

7,408,000+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07059325?term=rtms

Accelerated TMS for Seizure-Type Functional Neurologic ...

The purpose of this project is to assess the feasibility, tolerability, and preliminary efficacy of using an accelerated, intermittent theta burst stimulation ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6128773/

Right Temporoparietal Junction Transcranial Magnetic ...

One study observed a decrease in non-epileptic seizure frequency in a sample of 42 PNES patients using low frequency (1 Hz) large-field rTMS ...

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05241366

TMS vs Conventional Therapy for the Treatment of ...

The aim of the study is to compare the effect of Transcranial Magnetic Stimulation (TMS) versus treatment with selective serotonin reuptake inhibitors (SSRIs), ...

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/29628295/

Right Temporoparietal Junction Transcranial Magnetic ...

RESULTS: Treatment with rTMS was well tolerated by all participants. Participants reported a decrease in weekly seizure rates post vs. pre- ...

5.

aesnet.org

aesnet.org/abstractslisting/non-epileptic-seizures-(nes)-associated-with-functional-(psychogenic)-paralysis-(fp)--efficacy-of-multi-pulses-tms

NON-EPILEPTIC-SEIZURES-(NES) - American Epilepsy Society

In a previous study, we have shown that multi pulseTMS with circular coil on midline central and frontal area was effective in 89% of 70 ...

6.

pmc.ncbi.nlm.nih.gov

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

TMS Safety with Respect to Seizures: A Literature Review

Although rare, seizures are a potential adverse event of TMS treatment. In this article, we discuss TMS-related seizures with the various coils ...

7.

tmslab.org

tmslab.org/publications/112.pdf

Safety and Tolerability of Repetitive TMS in Epilepsy Patients

Status epilepticus or life-threatening seizures have not been reported in patients undergoing rTMS treatment. rTMS thus appears to be nearly as safe in patients ...

8.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1525505005002192

Transcranial magnetic stimulation treatment for epilepsy

Safety of rTMS in patients with epilepsy. Because TMS is an experimental tool used to measure and modulate brain cortical excitability and can provoke seizures ...

9.

withpower.com

withpower.com/trial/early-phase-1-functional-neurological-symptom-disorder-8-2025-b464b

Transcranial Magnetic Stimulation for Nonepileptic Seizures

The FND-seiz medical study, being run by Medical University of South Carolina, is evaluating whether Accelerated TMS will have tolerable side effects ...