Transcranial Magnetic Stimulation for Nonepileptic Seizures
(FND-seiz Trial)
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.12345
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.26789
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive 6-to-10 iTBS-rTMS sessions per day over 3-to-5 treatment days, targeting the left dorsolateral prefrontal cortex
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessments of seizure frequency and quality of life
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
Find a Clinic Near You
Who Is Running the Clinical Trial?
Medical University of South Carolina
Lead Sponsor