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New treatment option for Functional Neurological Symptom Disorder
Official title Accelerated TMS for Seizure-Type Functional Neurologic Disorders
ClinicalTrials.gov ID: NCT07059325
What this study is testing
- What it's testing
- 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).
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- \>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...
- In addition to meeting ILAE minimum requirements for FND-seiz diagnosis, must have previously undergone and documented in the electronic medical...
- Duration of symptoms \>3 months and continuing to experience NES at least monthly
You likely can't join if
- 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...
- History of central nervous system surgeries or clinically relevant structural brain lesions
See the full eligibility 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...
- 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...
- 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...
- 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
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Charleston, South Carolina, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Charleston, South Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.