Actively Recruiting

Early Phase 1
Age: 18Years - 65Years
All Genders
ID07059325

Accelerated, Left Prefrontal Transcranial Magnetic Stimulation for Functional Seizures; An Open-Label Exploration of Feasibility, Tolerability, and Preliminary Efficacy

Led by Medical University of South Carolina · Updated on 2025-09-22

30

Participants Needed

1

Research Sites

43 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the use of an accelerated, intermittent theta burst stimulation (a-iTBS-rTMS) protocol targeting the left dorsolateral prefrontal cortex for people with Psychogenic Non-Epileptic Seizures (PNES) or Seizure-Type Functional Neurologic Disorder (FND-seiz). This early-phase study aims to assess the feasibility, tolerability, and preliminary effects of this brain-network based treatment, which may help address the challenges and poor outcomes seen with current treatments. The study is open-label and focuses on improving seizure frequency and quality of life measures in this population. Participants will receive 6 to 10 sessions of theta burst TMS per day, each session consisting of 600 pulses, over 3 to 5 days, targeting a total of 30 sessions (18,000 pulses). Treatment is delivered using a MagVenture MagPro TMS System aimed at a specific brain region called Beam F3 to align with previous research and clinical practice. The sessions are spaced with 15-minute intervals, and the study includes a safety protocol developed with experts to monitor risks, including seizure induction. During the study, participants will be assessed through self-report measures before treatment and again four weeks after completing sessions. Researchers will track seizure frequency, stigma, quality of life, depression, PTSD, somatic symptoms, psychosocial functioning, and overall improvement. Safety is monitored daily during treatment and at follow-up. The total participation duration covers screening, treatment days, and a 4-week follow-up to evaluate the intervention's effects and tolerability.

CONDITIONS

Brief Title

Accelerated TMS for Seizure-Type Functional Neurologic Disorders

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Between 18 and 65 years old
  • English speaking, able to read, write, and provide informed consent
  • Diagnosed with documented Functional Seizures by a neurologist using EEG and clinical evaluation
  • Completed at least 24 hours of normal video EEG without epileptiform findings
  • Symptoms lasting more than 3 months with monthly non-epileptic seizures
  • Not currently undergoing psychotherapy and agree to avoid it during the study
  • Stable psychotropic medication doses if applicable and agree not to change them during the study
  • In good general health based on medical history
  • Females aged 18 to 50 must have a negative pregnancy test within 72 hours before first TMS session
Not Eligible

You will not qualify if you...

  • History or concern of epileptic seizures or epilepsy
  • Current psychosis, mania, or active alcohol/substance use disorder
  • Positive drug screening for cocaine, amphetamines, barbiturates, or opiates within the past year
  • Active suicidal intent or high depression score on screening
  • Use of medications that increase seizure risk at certain doses
  • History of brain surgeries or significant brain lesions
  • Significant unstable medical or psychiatric conditions impacting safety
  • Participation in other clinical trials with investigational drugs or devices within the past month
  • Previous exposure to TMS
  • Contraindications to TMS such as certain implants or conditions
  • Current pregnancy or plans to become pregnant without contraception
  • Being a prisoner or in police custody at screening

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - 3 to 5 days

Participants receive accelerated transcranial magnetic stimulation sessions targeting the left dorsolateral prefrontal cortex over 3 to 5 treatment days.

6 to 10 sessions per day

Follow-up

Duration - 4 weeks

Participants are monitored for safety, tolerability, and preliminary efficacy outcomes for 4 weeks after completing the TMS treatment.

1 visit (in-person) at 4 weeks post-treatment

Trial Site Locations

Total: 1 location

1

Institute of Psychiatry, Brain Stimulation Department

Charleston, South Carolina, United States, 29425

Actively Recruiting

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Research Team

R

Recruitment Coordinator

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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Published Research Related To This Trial

Effects of repetitive transcranial magnetic stimulation of the left dorsolateral prefrontal cortex on symptom domains in neuropsychiatric disorders: a systematic review and cross-diagnostic meta-analysis.

Rebecca L D Kan, Frank Padberg, Cristian G Giron...

https://pubmed.ncbi.nlm.nih.gov/36898403

Left dorsolateral prefrontal cortex activation can accelerate stress recovery: A repetitive transcranial stimulation study.

Yuanyuan Wang, Heming Gao, Mingming Qi

https://pubmed.ncbi.nlm.nih.gov/37221649

Network Mechanisms of Clinical Response to Transcranial Magnetic Stimulation in Posttraumatic Stress Disorder and Major Depressive Disorder.

Noah S Philip, Jennifer Barredo, Mascha van 't Wout-Frank...

https://pubmed.ncbi.nlm.nih.gov/28886760

An integrative neurocircuit perspective on psychogenic nonepileptic seizures and functional movement disorders: neural functional unawareness.

David L Perez, Barbara A Dworetzky, Bradford C Dickerson...

https://pubmed.ncbi.nlm.nih.gov/25432161