Accelerated TMS for Seizure-Type Functional Neurologic Disorders
NCT ID: NCT07059325
Last Updated: 2025-09-22
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Clinical Phase
EARLY_PHASE1
Total Enrollment
30 participants
Study Classification
INTERVENTIONAL
Study Start Date
2025-09-02
Study Completion Date
2027-07-01
Brief Summary
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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.
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.
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Detailed Description
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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 the associated barriers to treatment and dismal outcomes. Due to resource-intensive requirements, diagnosis is often delayed by years. In the interim, patients frequently receive inappropriate antiseizure medications and have high utilization of emergency services. Years after diagnosis, many FND-seiz patients continue to experience non-epileptic seizures (NS) and have high rates of disability. Due to stigma and psychosocial barriers, engagement and responses to the standard of care, Cognitive Behavioral Therapy (CBT), are inconsistent. As many patients are told they may have epilepsy prior to receiving an accurate diagnosis, there is an obvious disconnect between the recommended psychological treatment and the physical nature of their symptoms, which can limit acceptance of the diagnosis and subsequently CBT engagement. Furthermore, the only powered RCT (the CODES trial) examining CBT in FND-seiz failed to show a significant seizure reduction at 12 months follow up and the overall effect size was lower than previously thought highlighting the limitations of a "one-size-fits-all" model for a highly comorbid disorder. Ultimately, patients with FND-seiz have been found to have a poorer overall quality of life compared to epilepsy and a standardized mortality rate 2.5 times greater the general population and comparable to that of drug-resistant epilepsy
Together these factors underscore the need for alternate treatments capable of addressing psychosocial challenges unique to FND-seiz or further investigating the underlying neurobiology. Investigators theorize that offering a brain-network based approach may reduce stigma associated with confusion over the "psychological" rather than "neurological" etiologic conception of FND-seiz, which if effective, may be a more feasible for some patients. Brain-imaging research and prior reports of benefit with neurostimulation suggests TMS to the left dorsolateral prefrontal cortex (l-dlPFC) has the potential to improve cortico-limbic or cortico-sensorimotor governance, which Investigators theorize in FND-seiz may decrease NS frequency or improve quality of life. Thus, Investigators aim to investigate the feasibility and tolerability of an accelerated, intermittent theta-burst TMS protocol in FND-seiz to best mimic current clinical trends and optimize TMS feasibility, which may have several applications for the FND-seiz population.
In clinical practice, the known, but rare risk of inducing an epileptic seizure with TMS and the difficulty differentiating epileptic from non-epileptic seizures, may decrease the comfort of TMS providers to use TMS in FND-seiz patients when indicated for other disabling disorders. In tandem with exploring the feasibility and tolerability of this intervention, Investigators hope to employ and investigate an informed safety protocol, with input from experts in the fields of epilepsy and brain stimulation. Helping providers safely screen patients, more decisively exclude patients with an inaccurate diagnosis or concomitant epilepsy and having a protocol to follow when treating FND-seiz patients who experience a NS during TMS stimulation may increase TMS access for FND-seiz patients with other TMS indications. Finally, as preliminary evidence here at MUSC also suggests combining TMS with CBT for other indications may have a synergistic effect and improve attrition with CBT, if TMS is preliminarily efficacious alone in FND-seiz specific outcomes in a small, open-label sample, this investigation may also help optimize future methodologies examining the use of TMS in FND-seiz.
Together these factors underscore the need for alternate treatments capable of addressing psychosocial challenges unique to FND-seiz or further investigating the underlying neurobiology. Investigators theorize that offering a brain-network based approach may reduce stigma associated with confusion over the "psychological" rather than "neurological" etiologic conception of FND-seiz, which if effective, may be a more feasible for some patients. Brain-imaging research and prior reports of benefit with neurostimulation suggests TMS to the left dorsolateral prefrontal cortex (l-dlPFC) has the potential to improve cortico-limbic or cortico-sensorimotor governance, which Investigators theorize in FND-seiz may decrease NS frequency or improve quality of life. Thus, Investigators aim to investigate the feasibility and tolerability of an accelerated, intermittent theta-burst TMS protocol in FND-seiz to best mimic current clinical trends and optimize TMS feasibility, which may have several applications for the FND-seiz population.
In clinical practice, the known, but rare risk of inducing an epileptic seizure with TMS and the difficulty differentiating epileptic from non-epileptic seizures, may decrease the comfort of TMS providers to use TMS in FND-seiz patients when indicated for other disabling disorders. In tandem with exploring the feasibility and tolerability of this intervention, Investigators hope to employ and investigate an informed safety protocol, with input from experts in the fields of epilepsy and brain stimulation. Helping providers safely screen patients, more decisively exclude patients with an inaccurate diagnosis or concomitant epilepsy and having a protocol to follow when treating FND-seiz patients who experience a NS during TMS stimulation may increase TMS access for FND-seiz patients with other TMS indications. Finally, as preliminary evidence here at MUSC also suggests combining TMS with CBT for other indications may have a synergistic effect and improve attrition with CBT, if TMS is preliminarily efficacious alone in FND-seiz specific outcomes in a small, open-label sample, this investigation may also help optimize future methodologies examining the use of TMS in FND-seiz.
Conditions
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Functional Neurological Symptom Disorder
Functional Seizures
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
This is a single-arm open label investigation of the safety, feasibility, and tolerability of an accelerated TMS protocol in patients with Functional Seizures, also known as Psychogenic Non-Epileptic Seizures, with a secondary aim of examining preliminary efficacy.
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Interventional Arm
Group Type
EXPERIMENTAL
Transcranial Magnetic Stimulation
Intervention Type
DEVICE
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.
Interventions
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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.
Intervention Type
DEVICE
Other Intervention Names
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Accelerated TMS
Theta-burst TMS
Eligibility Criteria
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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
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
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
Minimum Eligible Age
18 Years
Maximum Eligible Age
65 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Medical University of South Carolina
OTHER
Sponsor Role
lead
Responsible Party
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Joseph Chasen
Principle Investigator, Resident Physician, MUSC Departments of Psychiatry and Neurology
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Joseph Chasen, DO
Role: PRINCIPAL_INVESTIGATOR
Medical University of South Carolina
Locations
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Institute of Psychiatry, Brain Stimulation Department
Charleston, South Carolina, United States
Site Status
RECRUITING
Countries
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United States
Central Contacts
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Facility Contacts
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References
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Kan RLD, Padberg F, Giron CG, Lin TTZ, Zhang BBB, Brunoni AR, Kranz GS. 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. Lancet Psychiatry. 2023 Apr;10(4):252-259. doi: 10.1016/S2215-0366(23)00026-3. Epub 2023 Mar 7.
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Wang Y, Gao H, Qi M. Left dorsolateral prefrontal cortex activation can accelerate stress recovery: A repetitive transcranial stimulation study. Psychophysiology. 2023 Oct;60(10):e14352. doi: 10.1111/psyp.14352. Epub 2023 May 23.
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Philip NS, Barredo J, van 't Wout-Frank M, Tyrka AR, Price LH, Carpenter LL. Network Mechanisms of Clinical Response to Transcranial Magnetic Stimulation in Posttraumatic Stress Disorder and Major Depressive Disorder. Biol Psychiatry. 2018 Feb 1;83(3):263-272. doi: 10.1016/j.biopsych.2017.07.021. Epub 2017 Aug 8.
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Hassa T, Sebastian A, Liepert J, Weiller C, Schmidt R, Tuscher O. Symptom-specific amygdala hyperactivity modulates motor control network in conversion disorder. Neuroimage Clin. 2017 Apr 27;15:143-150. doi: 10.1016/j.nicl.2017.04.004. eCollection 2017.
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Mcsweeney M, Reuber M, Levita L. Neuroimaging studies in patients with psychogenic non-epileptic seizures: A systematic meta-review. Neuroimage Clin. 2017 Jul 27;16:210-221. doi: 10.1016/j.nicl.2017.07.025. eCollection 2017.
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BACKGROUND
Perez DL, Dworetzky BA, Dickerson BC, Leung L, Cohn R, Baslet G, Silbersweig DA. An integrative neurocircuit perspective on psychogenic nonepileptic seizures and functional movement disorders: neural functional unawareness. Clin EEG Neurosci. 2015 Jan;46(1):4-15. doi: 10.1177/1550059414555905. Epub 2014 Nov 27.
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Perez DL, Nicholson TR, Asadi-Pooya AA, Begue I, Butler M, Carson AJ, David AS, Deeley Q, Diez I, Edwards MJ, Espay AJ, Gelauff JM, Hallett M, Horovitz SG, Jungilligens J, Kanaan RAA, Tijssen MAJ, Kozlowska K, LaFaver K, LaFrance WC Jr, Lidstone SC, Marapin RS, Maurer CW, Modirrousta M, Reinders AATS, Sojka P, Staab JP, Stone J, Szaflarski JP, Aybek S. Neuroimaging in Functional Neurological Disorder: State of the Field and Research Agenda. Neuroimage Clin. 2021;30:102623. doi: 10.1016/j.nicl.2021.102623. Epub 2021 Mar 11.
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McLoughlin C, McWhirter L, Pisegna K, Tijssen MAJ, Tak LM, Carson A, Stone J. Stigma in functional neurological disorder (FND) - A systematic review. Clin Psychol Rev. 2024 Aug;112:102460. doi: 10.1016/j.cpr.2024.102460. Epub 2024 Jun 13.
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Robson C, Myers L, Pretorius C, Lian OS, Reuber M. Health related quality of life of people with non-epileptic seizures: The role of socio-demographic characteristics and stigma. Seizure. 2018 Feb;55:93-99. doi: 10.1016/j.seizure.2018.01.001. Epub 2018 Jan 12.
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BACKGROUND
Samuels T, Pretorius C. Healthcare providers' perspectives on stigma when working with people with functional seizures. Seizure. 2023 Nov;112:121-127. doi: 10.1016/j.seizure.2023.10.002. Epub 2023 Oct 1.
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BACKGROUND
Karterud HN, Otto Nakken K, Lossius MI, Tschamper M, Ingebrigtesen T, Henning O. Young people diagnosed with psychogenic nonepileptic seizures (PNES) years ago - How are they now? Epilepsy Behav. 2024 Aug;157:109874. doi: 10.1016/j.yebeh.2024.109874. Epub 2024 Jun 7.
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Abi-Nahed R, Li J, Carlier J, Birca V, Berube AA, Nguyen DK. Outcome of psychogenic non-epileptic seizures following diagnosis in the epilepsy monitoring unit. Front Neurol. 2024 Feb 14;15:1363459. doi: 10.3389/fneur.2024.1363459. eCollection 2024.
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Fettig M, El-Hage W, Klemina I, Biberon J, de Toffol B, Thiriaux A, Visseaux JF, Lemesle Martin M, Schwan R, Bechiri F, Cohn A, Meyer M, Maillard L, Hingray C. Adherence to mental health care and caregiver-patient relationship after diagnosis of psychogenic non-epileptic seizures: Longitudinal follow-up study. Seizure. 2020 Aug;80:227-233. doi: 10.1016/j.seizure.2020.06.001. Epub 2020 Jun 8.
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Goldstein LH, Robinson EJ, Mellers JDC, Stone J, Carson A, Reuber M, Medford N, McCrone P, Murray J, Richardson MP, Pilecka I, Eastwood C, Moore M, Mosweu I, Perdue I, Landau S, Chalder T; CODES study group. Cognitive behavioural therapy for adults with dissociative seizures (CODES): a pragmatic, multicentre, randomised controlled trial. Lancet Psychiatry. 2020 Jun;7(6):491-505. doi: 10.1016/S2215-0366(20)30128-0. Epub 2020 May 20.
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Dworetzky BA. Neglected patients, few treatments, and minimal evidence: the updated cochrane review on psychological and behavioral treatments for nonepileptic seizures. Epilepsy Curr. 2014 Nov-Dec;14(6):329-31. doi: 10.5698/1535-7597-14.6.329. No abstract available.
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Stephen CD, Fung V, Lungu CI, Espay AJ. Assessment of Emergency Department and Inpatient Use and Costs in Adult and Pediatric Functional Neurological Disorders. JAMA Neurol. 2021 Jan 1;78(1):88-101. doi: 10.1001/jamaneurol.2020.3753.
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Kerr WT, Zhang X, Hill CE, Janio EA, Chau AM, Braesch CT, Le JM, Hori JM, Patel AB, Allas CH, Karimi AH, Dubey I, Sreenivasan SS, Gallardo NL, Bauirjan J, Hwang ES, Davis EC, D'Ambrosio SR, Al Banna M, Cho AY, Dewar SR, Engel J Jr, Feusner JD, Stern JM. Factors associated with delay to video-EEG in dissociative seizures. Seizure. 2021 Mar;86:155-160. doi: 10.1016/j.seizure.2021.02.018. Epub 2021 Feb 15.
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Kerr WT, Janio EA, Le JM, Hori JM, Patel AB, Gallardo NL, Bauirjan J, Chau AM, D'Ambrosio SR, Cho AY, Engel J Jr, Cohen MS, Stern JM. Diagnostic delay in psychogenic seizures and the association with anti-seizure medication trials. Seizure. 2016 Aug;40:123-6. doi: 10.1016/j.seizure.2016.06.015. Epub 2016 Jun 23.
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LaFrance WC Jr, Baker GA, Duncan R, Goldstein LH, Reuber M. Minimum requirements for the diagnosis of psychogenic nonepileptic seizures: a staged approach: a report from the International League Against Epilepsy Nonepileptic Seizures Task Force. Epilepsia. 2013 Nov;54(11):2005-18. doi: 10.1111/epi.12356. Epub 2013 Sep 20.
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BACKGROUND
Devinsky O, Gazzola D, LaFrance WC Jr. Differentiating between nonepileptic and epileptic seizures. Nat Rev Neurol. 2011 Apr;7(4):210-20. doi: 10.1038/nrneurol.2011.24. Epub 2011 Mar 8.
Reference Type
BACKGROUND
Other Identifiers
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Pro00144502
Identifier Type: -
Identifier Source: org_study_id
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UNKNOWN
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