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NCT07059325 · ClinicalTrials.gov registry record · Early Phase 1
Accelerated TMS for Seizure-Type Functional Neurologic Disorders
A Early Phase 1 study of Functional Neurological Symptom Disorder and Functional Seizures, sponsored by Medical University of South Carolina.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT07059325: Recruiting Early Phase 1 study of Functional Neurological Symptom Disorder and Functional Seizures, sponsored by Medical University of South Carolina.
NCT07059325 is a Early Phase 1 study of Functional Neurological Symptom Disorder and Functional Seizures that is actively recruiting participants, run by Medical University of South Carolina. The registered enrollment target is 30 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (43% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07059325, a Early Phase 1 study of Functional Neurological Symptom Disorder and Functional Seizures, is actively recruiting participants, sponsored by Medical University of South Carolina.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
Description: Feasibility will be measured as the percentage of participants who complete at least 20 rTMS-iTBS treatment sessions within the 3-to-5-day treatment period. Unit of Measure: Percentage (%) Time Frame: Assessed daily from Day 1 to Day 5 of the TMS treatment period and summarized at the 4-week follow-up visit. Rationale: This measure focuses on the proportion of participants able to adhere to the intensive TMS protocol, a key indicator of feasibility. The time frame is now specific,
Conditions Studied
Interventions
- DEVICE Transcranial Magnetic Stimulation
Study Locations (1)
South Carolina
- Institute of Psychiatry, Brain Stimulation Department - Charleston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2025-09-02 |
| Est. Completion | 2027-07-01 |
| Phase | Early Phase 1 |
What NCT07059325 shows while recruiting
NCT07059325 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (43% lower).
The record links to 2 conditions, with Functional Neurological Symptom Disorder appearing as the primary indexed condition, and to 1 intervention - of which Transcranial Magnetic Stimulation is the first listed.
NCT07059325 reports a single indexed study location in South Carolina.
Frequently Asked Questions
What is clinical trial NCT07059325 about?
NCT07059325 is a clinical study titled "Accelerated TMS for Seizure-Type Functional Neurologic Disorders". 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-T...
What is the current status of trial NCT07059325?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 30 participants. The study started on 2025-09-02. Estimated completion is 2027-07-01.
What conditions does trial NCT07059325 study?
This clinical trial studies the following conditions: Functional Neurological Symptom Disorder, Functional Seizures.
What interventions are being tested in trial NCT07059325?
The interventions under investigation include: Transcranial Magnetic Stimulation (DEVICE).
Who is sponsoring clinical trial NCT07059325?
This trial is sponsored by Medical University of South Carolina, which has 755 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07059325 being conducted?
This trial has 1 study location across South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT07059325's enrollment target sits among peer trials
30 807th of 2000 higher than 1,075 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
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Source ClinicalTrials.gov registry export · 2026-08-08
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