Actively Recruiting
Accelerated TMS for Seizure-Type Functional Neurologic Disorders
Led by Medical University of South Carolina · Updated on 2025-09-22
30
Participants Needed
1
Research Sites
95 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this project is to assess the feasibility, tolerability, and preliminary efficacy of using an accelerated, intermittent theta burst stimulation (a-iTBS-rTMS) protocol targeting the left dorsolateral prefrontal cortex (l-dlPFC) for Psychogenic Non-Epileptic Seizures (PNES) or Seizure-Type Functional Neurologic Disorder (FND-seiz) in an open-label fashion. Following screening, consent, and enrollment, participants will receive 6-to-10 iTBS-rTMS sessions per day (i.e., theta burst; 600 pulses per session; 6000 pulses per day) over a 3-to-5 treatment days with a target of 30 total sessions (18,000 total pulses). TMS will be targeted to Beam F3 for comparison to the bulk of the literature and to most mimic replicable and clinical use. This proposed iTBS-rTMS protocol was chosen given its previously shown safety, tolerability, and effectiveness in other conditions, but also as it has the potential to shorten treatment to only 3 days, which investigators theorize will be more feasible for patients with FND-seiz. Feasibility will be measured as the percentage of participants who receive at least 20 treatment sessions within the 3-to-5-day window. Other than self-assessments used in the safety screening process or to monitor TMS benefits and risks, secondary subjective measures will assess previously investigated FND-seiz-specific outcomes, which will be obtained prior to intervention and 4-weeks post-intervention. In addition to monthly seizure frequency, this will include validated measures regarding stigma, health-related QOL, depression, PTSD, somatic symptoms, psychosocial functioning, psychological distress, and clinical and participant impression of improvement and satisfaction. Sub-analysis will further divide participants with mild to no depression and/or PTSD versus moderate to severe depression and/or PTSD to further assess how the TMS effects known to effect other highly comorbid disorders with FND-seiz, may indirectly affect FND-seiz outcomes.
CONDITIONS
Official Title
Accelerated TMS for Seizure-Type Functional Neurologic Disorders
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Between 18 and 65 years old
- English speaking, able to read and write, and provide informed consent
- Diagnosed with documented Functional Seizures by a neurologist or epileptologist using recommended guidelines
- Have undergone at least 24 hours of normal video EEG without epileptiform findings
- Symptoms lasting more than 3 months with at least monthly non-epileptic seizures
- Not currently receiving psychotherapy and agree to avoid psychotherapy during the study
- If on psychotropic medications, doses must remain stable during the study
- In good general health based on medical history
- Females aged 18 to 50 must have a negative urine pregnancy test within 72 hours before the first TMS session
You will not qualify if you...
- History or concern of epileptic seizures or epilepsy
- Current psychosis, mania, active alcohol or substance use disorder
- Positive urine drug test for cocaine, amphetamines, barbiturates, or opiates within the past year
- Active suicidal intent or high score on depression screening question
- Use of medications that lower seizure threshold at risky doses for TMS
- History of central nervous system surgery or significant brain lesions
- Serious or unstable cardiac, metabolic, oncologic, psychiatric, developmental, or neurologic conditions
- Participation in another clinical trial with investigational drug or device within past month
- Previous exposure to TMS
- Contraindications to TMS such as ferromagnetic or cochlear implants
- Current pregnancy or planning pregnancy without contraception
- Being a prisoner or in police custody at screening
AI-Screening
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Trial Site Locations
Total: 1 location
1
Institute of Psychiatry, Brain Stimulation Department
Charleston, South Carolina, United States, 29425
Actively Recruiting
Research Team
R
Recruitment Coordinator
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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