Recruiting
Early Phase 1

a-iTBS-rTMS

Sponsor:

Medical University of South Carolina

Code:

NCT07059325

Conditions

Functional Neurological Symptom Disorder

Functional Seizures

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Transcranial Magnetic Stimulation

Study Details

Brief 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.

Conditions

Functional Neurological Symptom Disorder

Functional Seizures

Study ID

NCT07059325

Start date

Sep 2, 2025

Status verified date

Sep, 2025

Completion date

Jul 1, 2027

Anticipated

Primary completion date

Sep 2, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. >18 years old and <65 years old
2. English Speaking, can read and write, and able to provide informed consent
3. Diagnosis of "documented" Functional Seizures as made by an MUSC epileptologist or neurologist using the ILAE recommendations: "by clinician experienced in diagnosis of seizure disorders (on video or in person), showing semiology of typical of FND-seiz, while on EEG plus no epileptiform activity on routine or ambulatory ictal EEG during a typical ictus/event in which the semiology would make ictal epileptiform EEG activity expected during equivalent epileptic seizures"2
4. In addition to meeting ILAE minimum requirements for FND-seiz diagnosis, must have previously undergone and documented in the electronic medical record a minimum of 24-hours of otherwise normal video EEG without interictal epileptiform findings
5. Duration of symptoms >3 months and continuing to experience NES at least monthly
6. Not currently undergoing any psychotherapeutic intervention, agree to forgo any psychotherapeutic intervention during the study, and if previously completed any psychotherapeutic intervention continue to experience monthly non-epileptic seizures
7. If on psychotropic medications may choose to continue during the duration of the study at current doses, but consent to not modifying medication doses or switching to alternative psychotropic regimens during the trial
8. In good general health, as ascertained by medical history
9. Females of reproductive age (ages 18 to 50) must have a negative urine pregnancy test, performed onsite, and documented in the study record within 72 hours prior to the first TMS session

Exclusion Criteria:

1. History of clinical concern for concomitant epileptic seizures or epilepsy
2. History of ongoing psychosis, mania, active alcohol or substance use disorder as screened by the PSQ, YMRS, AUDIT, and DAST-10
3. History of positive screening urine test for drugs of abuse within the last year: cocaine, amphetamines, barbiturates, opiates
4. Active suicidal intent or a score >2 on question 3 of the HAM-D
5. Use of medications known to lower the seizure threshold at doses that may increase this risk in the setting of rTMS-iTBS (i.e. buproprion at >300 mg, combinations of tricyclic antidepressants, antipsychotics… as determined by investigators)
6. History of central nervous system surgeries or clinically relevant structural brain lesions
7. Significant or unstable cardiac, metabolic, oncologic, psychiatric, developmental, or neurologic condition(s) or treatments that may impact safe participation in the study as determined by the study investigators (e.g. poorly-controlled heart failure, current or past cardiac arrhythmia, sustained systolic blood pressure >180, labile diabetes, significant electrolyte abnormality, brain cancer, cognitive impairment, neurodevelopmental disorders, autism spectrum disorder, mania, schizophrenia spectrum or other psychotic disorder, movement disorders, multiple sclerosis, moderate to severe brain injury)
8. Participation in any clinical trial with an investigational drug or device within the past month or concurrent to study participation
9. History of TMS exposure
10. TMS contraindications (e.g., ferromagnetic implants, cochlear implants, conditions or treat-ments that lower seizure threshold - as determined by study investigators).
11. Current pregnancy or desire to become pregnant during study duration without contraceptive plan
12. Are a prisoner or in police custody at the time of eligibility screening

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Interventional Arm

Interventions

Transcranial Magnetic Stimulation

Participants will receive 6 to 10 sessions per day (i.e., theta burst; 600 pulses per session; 6000 pulses per day) over 3 to 5 treatment days using a MagVenture MagPro TMS System. Treatment will consist of a total of 30 sessions (18,000 total pulses). A single session is defined as 600 pulses at 50 Hz for 2s (i.e., 5 Hz triplets) and repeated every 10s for a total of 190s per session to l-dlPFC at 120% rMT with 15-minute intersession intervals. TMS will be targeted to Beam F3 for comparison to the bulk of the literature and to most mimic replicable clinical use.

Primary outcome measure

  • Percentage of Participants Completing TMS Sessions [ Time Frame: Assessed daily from Day 1 to Day 5 of the TMS treatment period and summarized at the 4-week follow-up visit. ]
  • Session Delivery Patterns [ Time Frame: Recorded daily from Day 1 to Day 5 of the TMS treatment period and summarized at the 4-week follow-up visit. ]
  • Adverse Event Rate [ Time Frame: Assessed daily from Day 1 to Day 5 of the TMS treatment period, at the initial screening visit (baseline), and at the 4-week follow-up visit. ]
  • Serious Adverse Event Rate [ Time Frame: Assessed daily from Day 1 to Day 5 of the TMS treatment period, at the initial screening visit (baseline), and at the 4-week follow-up visit. ]
  • Pulses per Session Delivery Patterns [ Time Frame: Recorded daily from Day 1 to Day 5 of the TMS treatment period and summarized at the 4-week follow-up visit. ]

Central Contacts and Locations

Central contacts

Recruitment Coordinator

(843) 637-1358chasenj@musc.edu

Locations

Institute of Psychiatry, Brain Stimulation Department

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Joseph A Chasen, DO

8436371358chasenj@musc.edu

Principal Investigator:

Joseph A Chasen, DO

More Information

Sponsor

Medical University of South Carolina

Last update posted

Sep 22, 2025

Last verified

Sep, 2025

Keywords

  • Mental Health
  • Psychiatry
  • Functional Seizures
  • Transcranial Magnetic Stimulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Medical University of South Carolina on 2025-09-22.