Accelerated magnetic brain stimulation for seizure-type functional neurologic disorder
Accelerated, Left Prefrontal Transcranial Magnetic Stimulation for Functional Seizures; An Open-Label Exploration of Feasibility, Tolerability, and Preliminary Efficacy
This trial will try a shortened, intensified course of magnetic brain stimulation over the left frontal cortex to see if it reduces functional (non-epileptic) seizures in adults.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Medical University of South Carolina Academic / other |
| Locations | 1 site (Charleston, South Carolina) |
| Trial ID | NCT07059325 on ClinicalTrials.gov |
What this trial studies
This open-label early-phase trial tests the feasibility, tolerability, and preliminary efficacy of accelerated intermittent theta-burst TMS (a-iTBS-rTMS) targeted to the left dorsolateral prefrontal cortex (Beam F3). Participants receive 6–10 iTBS sessions per day (600 pulses per session; ~6,000 pulses/day) over 3–5 treatment days with a target of 30 total sessions (18,000 pulses). Eligible adults (18–65) must have documented seizure-type functional neurologic disorder (PNES/FND-seiz) confirmed by an experienced neurologist/epileptologist and at least 24 hours of otherwise normal video EEG, with ongoing monthly events. The protocol was chosen because similar iTBS regimens have shown safety and tolerability in other conditions and could substantially shorten treatment burden compared with standard TMS schedules.
Who should consider this trial
Good fit: Adults 18–65 with documented seizure-type functional neurologic disorder (psychogenic non-epileptic seizures) confirmed by an experienced neurologist/epileptologist and at least 24 hours of normal video EEG with ongoing monthly events.
Not a fit: Patients with epileptic seizures or interictal epileptiform activity on EEG, those outside the 18–65 age range, or those unable to attend multiple daily visits or give informed consent are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this could provide a well-tolerated, much shorter TMS course that reduces non-epileptic seizure frequency and related disability.
How similar studies have performed: Intermittent theta-burst and other TMS protocols have established safety and some efficacy in mood and other neurologic conditions, but accelerated iTBS for PNES/FND-seiz is novel and evidence in this population is very limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Charleston, South Carolina
- Institute of Psychiatry, Brain Stimulation Department — Charleston, South Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Joseph Chasen, DO — Medical University of South Carolina
- Study coordinator: Recruitment Coordinator
- Email: chasenj@musc.edu
- Phone: (843) 637-1358
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.