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Accelerated TMS for Seizure-Type Functional Neurologic Disorders

Study acronym: FND-seiz
StatusRecruiting
PhaseEarly Phase 1
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 4 months later Sep 2, 2026 → Jan 2, 2027
See other at-risk trials from Medical University of South Carolina

Record History

  1. Minor Primary completion pushed from Sep 2, 2026 to Jan 2, 2027 Eligibility criteria expanded, about 21 words · Secondary endpoints: details revised at 11 of 11 entries · Site contact updated · 1 more Show 4 more changesShow less
    • Eligibility criteria expanded, about 21 words
    • Secondary endpoints: details revised at 11 of 11 entries
    • Site contact updated
    • Publications: details revised at 26 of 26 entries
  2. Notable Trial status: Not Yet Recruiting to Recruiting Primary completion date: Dec 1, 2026 to Sep 2, 2026 · Start date changed from estimate of Sep 15, 2025 to Sep 2, 2025 · Eligibility criteria expanded, about 51 words · 1 morev3 Show 4 more changesShow less
    • Primary completion date: Dec 1, 2026 to Sep 2, 2026
    • Start date changed from estimate of Sep 15, 2025 to Sep 2, 2025
    • Eligibility criteria expanded, about 51 words
    • Site details revised

    See this version in full on ClinicalTrials.gov ↗

  3. Notable Start date: Aug 1, 2025 to Sep 15, 2025v2
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07059325
Lead Sponsor Medical University of South Carolina
Conditions Functional Neurological Symptom Disorder, Functional Seizures
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov