TMS vs Conventional Therapy for the Treatment of Functional Neurological Non Epileptic Seizure Disorder

NCT05241366 | Completed

• 1 other identifier: 16/21
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to compare the effect of Transcranial Magnetic Stimulation (TMS) versus treatment with selective serotonin reuptake inhibitors (SSRIs), in patients with diagnosis of Functional Neurological Non Epileptic Seizure Disorder (PNES).

Conditions

Psychogenic Non-Epileptic Seizure

Keywords

Transcranial Magnetic Stimulation; Selective Serotonin Reuptake Inhibitor; Functional Neurological Disorder

Outcome Measures

Primary Outcomes (4)

• PNES count (1/4)

  Participants in both groups will registered in a specific chart, daily psychogenic non-epileptic seizure activity.

  Baseline PNES count (Starting 1 month before TMS treatment)

• PNES count (2/4)

  Participants in both groups will registered in a specific chart, daily psychogenic non-epileptic seizure activity.

  Change from Baseline PNES count (immediately after the session 12th -last session-)

• PNES count (3/4)

  Participants in both groups will registered in a specific chart, daily psychogenic non-epileptic seizure activity.

  Change from Baseline PNES count at month 1 post treatment

• PNES count (4/4)

  Participants in both groups will registered in a specific chart, daily psychogenic non-epileptic seizure activity.

  Change from Baseline PNES count at month 2 post treatment

Secondary Outcomes (36)

• Psychometric self-assessment scales (BDI-II) 1/4

  Baseline score (1 month before TMS treatment)

• Psychometric self-assessment scales (BDI-II) 2/4

  Change from Baseline score (immediately after the 12th session -last session-)

• Psychometric self-assessment scales (BDI-II) 3/4

  Change from Baseline score at month 1 post treatment

• Psychometric self-assessment scales (BDI-II) 4/4

  Change from Baseline score at month 2 post treatment

• Psychometric self-assessment scales (DES) 1/4

  Baseline score (1 month before TMS treatment)

Study Arms (2)

Transcranial Magnetic Stimulation + usual treatment with SSRIs

EXPERIMENTAL

Transcranial Magnetic Stimulation + SSRIs The TMS group will be comprised of 10 patients, each subject will receive 12 sessions of low frequency (1 Hz) rTMS over right dorsolateral prefrontal cortex with a total of 1500 each session. All patients will continue with the usual treatment established by their treating physician. Those who do not have a previous pharmacological treatment will start a protocol with sertraline, which should be started at a 50 mg/day dosage.

Device: Transcranial Magnetic Stimulation

Sham TMS coil + usual treatment with SSRIs

SHAM COMPARATOR

The sham TMS coil group will be comprised of 10 patients, sham TMS stimulation will be performed with the B-65 coil, which has similar sound and scalp contact to those experienced during active stimulation. The duration of treatment will be the same as in the experimental arm. All patients will continue with the usual treatment established by their treating physician. Those who do not have a previous pharmacological treatment will start a protocol with sertraline, which should be started at a 50 mg/day dosage.

Device: Sham Transcranial Magnetic Stimulation coil

Interventions

Transcranial Magnetic Stimulation DEVICE

The TMS group will be comprised of 10 patients, each subject will receive 12 sessions of low frequency (1 Hz) rTMS over the right dorsolateral prefrontal cortex with a total of 1500 pulses in each session. Each session will last approximately 30 minutes. There will be one session per day, five sessions per week. The total duration of the treatment will be four weeks. All patients will continue with the usual treatment established by their treating physician. Those who do not have a previous pharmacological treatment will start a protocol with sertraline, which should be started at a 50 mg/day dosage.

Also known as: rTMS

Transcranial Magnetic Stimulation + usual treatment with SSRIs

Sham Transcranial Magnetic Stimulation coil DEVICE

Simulated TMS stimulation will be performed with a Sham TMS coil, which has a sound and scalp contact similar to those experienced during active stimulation. The duration of the treatment will be the same as in the experimental arm. All patients will continue with the usual treatment established by their treating physician. Those who do not have a previous pharmacological treatment will start a protocol with sertraline, which should be started at a 50 mg/day dosage.

Also known as: Sham TMS coil

Sham TMS coil + usual treatment with SSRIs

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with a diagnosis of PNES, based on the diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5) and the ILAE, confirmed by video recording and/or V-EEG monitoring, and who have a monthly seizure frequency greater than 3.
• Patients who have a record at the institute with the diagnosis of PNES.
• Patients with an encephalic MRI.
• Patients who give their written consent to participate in the protocol.
• Patients who have not had any changes in the pharmacological treatment in the last 6 weeks.

You may not qualify if:

• Patients who cannot answer the scales and other clinimetric instruments.
• Patients with a history of previous or current epilepsy.
• Patients with other major neurological comorbidities (tumor, cerebrovascular event (CVE), cranioencephalic trauma (TBI)).
• Patients currently taking medications that lower the seizure threshold (Bupropion).
• Patients with psychiatric comorbidities such as psychosis/bipolar disorder/substance abuse.
• Patients with certain implanted metallic devices (pacemakers).
• Pregnant women.

Sponsors & Collaborators

• El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez: lead

Study Sites (1)

Instituto Nacional de Neurologia Y Neurocirugia Mvs

Mexico City, Mexico City, 14269, Mexico

Location

Related Publications (15)

• Agarwal R, Garg S, Tikka SK, Khatri S, Goel D. Successful use of theta burst stimulation (TBS) for treating psychogenic non epileptic seizures (PNES) in a pregnant woman. Asian J Psychiatr. 2019 Jun;43:121-122. doi: 10.1016/j.ajp.2019.05.013. Epub 2019 May 8. No abstract available.

  PMID: 31125954 BACKGROUND

• LaFrance, W., & Blumer, D. (2018). Pharmacological Treatments for Psychogenic Nonepileptic Seizures. University of Warwick. Retrieved from: https://www.cambridge.org/core.

  BACKGROUND

• LaFrance WC Jr, Keitner GI, Papandonatos GD, Blum AS, Machan JT, Ryan CE, Miller IW. Pilot pharmacologic randomized controlled trial for psychogenic nonepileptic seizures. Neurology. 2010 Sep 28;75(13):1166-73. doi: 10.1212/WNL.0b013e3181f4d5a9. Epub 2010 Aug 25.

  PMID: 20739647 BACKGROUND

• Varia I, Logue E, O'connor C, Newby K, Wagner HR, Davenport C, Rathey K, Krishnan KR. Randomized trial of sertraline in patients with unexplained chest pain of noncardiac origin. Am Heart J. 2000 Sep;140(3):367-72. doi: 10.1067/mhj.2000.108514.

  PMID: 10966532 BACKGROUND

• Peterson, K., et al. (2017). Transcranial Magnetic Stimulation in the treatment of non-epileptic seizures: A Case Series. Max Rady College of Medicine. University of Manitoba.

  BACKGROUND

• Peterson KT, Kosior R, Meek BP, Ng M, Perez DL, Modirrousta M. Right Temporoparietal Junction Transcranial Magnetic Stimulation in the Treatment of Psychogenic Nonepileptic Seizures: A Case Series. Psychosomatics. 2018 Nov;59(6):601-606. doi: 10.1016/j.psym.2018.03.001. Epub 2018 Mar 7.

  PMID: 29628295 BACKGROUND

• Benbadis SR, Allen Hauser W. An estimate of the prevalence of psychogenic non-epileptic seizures. Seizure. 2000 Jun;9(4):280-1. doi: 10.1053/seiz.2000.0409.

  PMID: 10880289 BACKGROUND

• Duncan R, Razvi S, Mulhern S. Newly presenting psychogenic nonepileptic seizures: incidence, population characteristics, and early outcome from a prospective audit of a first seizure clinic. Epilepsy Behav. 2011 Feb;20(2):308-11. doi: 10.1016/j.yebeh.2010.10.022. Epub 2010 Dec 30.

  PMID: 21195031 BACKGROUND

• Kanemoto K, LaFrance WC Jr, Duncan R, Gigineishvili D, Park SP, Tadokoro Y, Ikeda H, Paul R, Zhou D, Taniguchi G, Kerr M, Oshima T, Jin K, Reuber M. PNES around the world: Where we are now and how we can close the diagnosis and treatment gaps-an ILAE PNES Task Force report. Epilepsia Open. 2017 Jun 23;2(3):307-316. doi: 10.1002/epi4.12060. eCollection 2017 Sep.

  PMID: 29588959 BACKGROUND

• Pollak TA, Nicholson TR, Edwards MJ, David AS. A systematic review of transcranial magnetic stimulation in the treatment of functional (conversion) neurological symptoms. J Neurol Neurosurg Psychiatry. 2014 Feb;85(2):191-7. doi: 10.1136/jnnp-2012-304181. Epub 2013 Jan 8.

  PMID: 23303960 BACKGROUND

• Dafotakis M, Ameli M, Vitinius F, Weber R, Albus C, Fink GR, Nowak DA. [Transcranial magnetic stimulation for psychogenic tremor - a pilot study]. Fortschr Neurol Psychiatr. 2011 Apr;79(4):226-33. doi: 10.1055/s-0029-1246094. Epub 2011 Apr 8. German.

  PMID: 21480152 BACKGROUND

• van der Kruijs SJ, Bodde NM, Vaessen MJ, Lazeron RH, Vonck K, Boon P, Hofman PA, Backes WH, Aldenkamp AP, Jansen JF. Functional connectivity of dissociation in patients with psychogenic non-epileptic seizures. J Neurol Neurosurg Psychiatry. 2012 Mar;83(3):239-47. doi: 10.1136/jnnp-2011-300776. Epub 2011 Nov 5.

  PMID: 22056967 BACKGROUND

• van der Kruijs SJ, Jagannathan SR, Bodde NM, Besseling RM, Lazeron RH, Vonck KE, Boon PA, Cluitmans PJ, Hofman PA, Backes WH, Aldenkamp AP, Jansen JF. Resting-state networks and dissociation in psychogenic non-epileptic seizures. J Psychiatr Res. 2014 Jul;54:126-33. doi: 10.1016/j.jpsychires.2014.03.010. Epub 2014 Mar 21.

  PMID: 24703187 BACKGROUND

• Parain D, Chastan N. Large-field repetitive transcranial magnetic stimulation with circular coil in the treatment of functional neurological symptoms. Neurophysiol Clin. 2014 Oct;44(4):425-31. doi: 10.1016/j.neucli.2014.04.004. Epub 2014 May 15.

  PMID: 25306083 BACKGROUND

• Nightscales R, McCartney L, Auvrez C, Tao G, Barnard S, Malpas CB, Perucca P, McIntosh A, Chen Z, Sivathamboo S, Ignatiadis S, Jones S, Adams S, Cook MJ, Kwan P, Velakoulis D, D'Souza W, Berkovic SF, O'Brien TJ. Mortality in patients with psychogenic nonepileptic seizures. Neurology. 2020 Aug 11;95(6):e643-e652. doi: 10.1212/WNL.0000000000009855. Epub 2020 Jul 20.

  PMID: 32690794 BACKGROUND

MeSH Terms

Conditions

Psychogenic Nonepileptic Seizures; Conversion Disorder

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Seizures; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Somatoform Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Édgar Daniel Crail Meléndez, MD

  Instituto Nacional de Neurología y Neurocirugía Manuel Velasco Suárez

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Double masking (Trial Participant/Outcomes Assessor)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MS

Model Details: Single-blind randomized controlled clinical trial. Non-probabilistic sampling of consecutive cases randomized to each arm of the study. The study will consist of a control group and a study group. The study group will receive a therapeutic scheme with Transcranial Magnetic Stimulation (TMS) + usual pharmacological treatment and the control group will receive an identical scheme with TMS simulated with a sham coil + usual pharmacological treatment.

Study Record Dates

• First Submitted: January 20, 2022
• First Posted: February 15, 2022
• Study Start: February 14, 2022
• Primary Completion: May 20, 2023
• Study Completion: July 31, 2023
• Last Updated: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)