Status:
RECRUITING
Accelerated TMS for Seizure-Type Functional Neurologic Disorders
Lead Sponsor:
Medical University of South Carolina
Conditions:
Functional Neurological Symptom Disorder
Functional Seizures
Eligibility:
All Genders
18-65 years
Phase:
EARLY_PHASE1
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...
Detailed Description
Seizure-Type Functional Neurologic Disorders (FND-seiz) are strikingly prevalent-accounting for 5-15% of epilepsy center referrals and up to 40% of epilepsy monitoring unit admissions-when considering...
Eligibility Criteria
Inclusion Criteria:
- >18 years old and <65 years old
- English Speaking, can read and write, and able to provide informed consent
- 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
- 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
- Duration of symptoms >3 months and continuing to experience NES at least monthly
- 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
- 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
- In good general health, as ascertained by medical history
- 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:
- History of clinical concern for concomitant epileptic seizures or epilepsy
- History of ongoing psychosis, mania, active alcohol or substance use disorder as screened by the PSQ, YMRS, AUDIT, and DAST-10
- History of positive screening urine test for drugs of abuse within the last year: cocaine, amphetamines, barbiturates, opiates
- Active suicidal intent or a score >2 on question 3 of the HAM-D
- 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)
- History of central nervous system surgeries or clinically relevant structural brain lesions
- 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)
- Participation in any clinical trial with an investigational drug or device within the past month or concurrent to study participation
- History of TMS exposure
- TMS contraindications (e.g., ferromagnetic implants, cochlear implants, conditions or treat-ments that lower seizure threshold - as determined by study investigators).
- Current pregnancy or desire to become pregnant during study duration without contraceptive plan
- Are a prisoner or in police custody at the time of eligibility screening
Key Trial Info
Start Date :
September 2 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2027
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT07059325
Start Date
September 2 2025
End Date
July 1 2027
Last Update
September 22 2025
Active Locations (1)
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1
Institute of Psychiatry, Brain Stimulation Department
Charleston, South Carolina, United States, 29425