Psychogenic Non-Epileptic SeizureNCT05241366

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

A study testing Transcranial Magnetic Stimulation in people with Psychogenic Non-Epileptic Seizure, run by El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez at 1 site in Mexico.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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). Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Psychogenic Non-Epileptic Seizure
What is being tested?: Transcranial Magnetic Stimulation
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 28 participants
Where: 1 siteMexico
Study dates: 14 Feb 2022to 31 Jul 2023
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Mexico1 site

Instituto Nacional de Neurologia Y Neurocirugia Mvs
Mexico City, Mexico City, 14269

Other trials in Mexico

About this study

Official title: Controlled Clinical Trial of Transcranial Magnetic Stimulation Versus Conventional Therapy for the Treatment of Functional Neurological Non-Epileptic Seizure Disorder: A Pilot Study

Read the detailed description

This study consists of a single-blind Randomized Controlled Clinical Trial comprised of 20 patients with diagnosis of Psychogenic Non Epileptic Seizures (PNES), distributed in 2 arms of 10 patients each.

Patients (n=20) will be randomly assigned (using the block randomization method) to one of the groups. Both groups of patients will be receiving their usual medical treatment (SSRIs), one group will receive in addition a therapeutic scheme with active TMS, while the second group will receive the same scheme, but with a sham TMS coil to decrease the bias of placebo effect.

Conditions: Psychogenic Non-Epileptic Seizure
Being tested: Transcranial Magnetic Stimulation, Sham Transcranial Magnetic Stimulation coil
Keywords: Transcranial Magnetic Stimulation, Selective Serotonin Reuptake Inhibitor, Functional Neurological Disorder
Medical subject headings: Psychogenic Nonepileptic Seizures, Conversion Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Transcranial Magnetic StimulationDevice
Also called rTMS
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.
Sham Transcranial Magnetic Stimulation coilDevice
Also called Sham TMS coil
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.

Study groups in NCT05241366
Study group	Role	What they receive
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. Receives: 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. Receives: Device: Sham Transcranial Magnetic Stimulation coil

What is being measured

The primary outcome is the main question the study is designed to answer.

PNES count (1/4)
Participants in both groups will registered in a specific chart, daily psychogenic non-epileptic seizure activity.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change from Baseline PNES count at month 2 post treatment

Secondary outcomes (36)

Psychometric self-assessment scales (BDI-II) 1/4
1.0) Mood: Beck Depression Inventory-II (BDI-II)
Minimum score: 0
Maximum score: 63
1-10: These ups and downs are considered normal
11-16: Mild mood disturbance
17-20: Borderline clinical depression
21-30: Moderate depression
31-40: Severe depression
over 40: Extreme depression
*Higher scores mean a worse outcome.
Measured: Baseline score (1 month before TMS treatment)
Psychometric self-assessment scales (BDI-II) 2/4
1.1) Mood: Beck Depression Inventory-II (BDI-II)
Minimum score: 0
Maximum score: 63
1-10: These ups and downs are considered normal
11-16: Mild mood disturbance
17-20: Borderline clinical depression
21-30: Moderate depression
31-40: Severe depression
over 40: Extreme depression
*Higher scores mean a worse outcome.
Measured: Change from Baseline score (immediately after the 12th session -last session-)
Psychometric self-assessment scales (BDI-II) 3/4
1.2) Mood: Beck Depression Inventory-II (BDI-II)
Minimum score: 0
Maximum score: 63
1-10: These ups and downs are considered normal
11-16: Mild mood disturbance
17-20: Borderline clinical depression
21-30: Moderate depression
31-40: Severe depression
over 40: Extreme depression
*Higher scores mean a worse outcome.
Measured: Change from Baseline score at month 1 post treatment
Psychometric self-assessment scales (BDI-II) 4/4
1.3) Mood: Beck Depression Inventory-II (BDI-II)
Minimum score: 0
Maximum score: 63
1-10: These ups and downs are considered normal
11-16: Mild mood disturbance
17-20: Borderline clinical depression
21-30: Moderate depression
31-40: Severe depression
over 40: Extreme depression
*Higher scores mean a worse outcome.
Measured: Change from Baseline score at month 2 post treatment
Psychometric self-assessment scales (DES) 1/4
2.0) Dissociation : Dissociative Experience Scale (DES).
Minimum score: 0
Maximum score: 100
High levels of dissociation are indicated by scores of 30 or more, scores under 30 indicate low levels.
*Higher scores mean a worse outcome.
Measured: Baseline score (1 month before TMS treatment)
Psychometric self-assessment scales (DES) 2/4
2.1) Dissociation : Dissociative Experience Scale (DES).
Minimum score: 0
Maximum score: 100
High levels of dissociation are indicated by scores of 30 or more, scores under 30 indicate low levels.
*Higher scores mean a worse outcome.
Measured: Change from Baseline score (immediately after the 12th session -last session-)
Psychometric self-assessment scales (DES) 3/4
2.2) Dissociation : Dissociative Experience Scale (DES).
Minimum score: 0
Maximum score: 100
High levels of dissociation are indicated by scores of 30 or more, scores under 30 indicate low levels.
*Higher scores mean a worse outcome.
Measured: Change from Baseline score at month 1 post treatment
Psychometric self-assessment scales (DES) 4/4
2.3) Dissociation : Dissociative Experience Scale (DES).
Minimum score: 0
Maximum score: 100
High levels of dissociation are indicated by scores of 30 or more, scores under 30 indicate low levels.
*Higher scores mean a worse outcome.
Measured: Change from Baseline score at month 2 post treatment
Psychometric self-assessment scales (PTSD) 1/4
3.0) PTSD/Trauma/Resilience: PTSD Symptom Severity Scale.
Minimum score: 0
Maximum score: 80
*Higher scores mean a worse outcome.
Measured: Baseline score (1 month before TMS treatment)
Psychometric self-assessment scales (PTSD) 2/4
3.1) PTSD/Trauma/Resilience: PTSD Symptom Severity Scale.
Minimum score: 0
Maximum score: 80
*Higher scores mean a worse outcome.
Measured: Change from Baseline score (immediately after the 12th session -last session-)
Psychometric self-assessment scales (PTSD) 3/4
3.2) PTSD/Trauma/Resilience: PTSD Symptom Severity Scale.
Minimum score: 0
Maximum score: 80
*Higher scores mean a worse outcome.
Measured: Change from Baseline score at month 1 post treatment
Psychometric self-assessment scales (PTSD) 4/4
3.3) PTSD/Trauma/Resilience: PTSD Symptom Severity Scale.
Minimum score: 0
Maximum score: 80
*Higher scores mean a worse outcome.
Measured: Change from Baseline score at month 2 post treatment
Psychometric self-assessment scales (MoCA) 1/4
4.0) Education and Cognition: Montreal Cognitive Assessment (MoCA).
Minimum score: 0
Maximum score: 30
Normal score: 26-30
Probable Neurocognitive Dissorder: 0-25
*Higher scores mean a better outcome.
Measured: Baseline score (1 month before TMS treatment)
Psychometric self-assessment scales (MoCA) 2/4
4.1) Education and Cognition: Montreal Cognitive Assessment (MoCA).
Minimum score: 0
Maximum score: 30
Normal score: 26-30
Probable Neurocognitive Dissorder: 0-25
*Higher scores mean a better outcome.
Measured: Change from Baseline score (immediately after the 12th session -last session-)
Psychometric self-assessment scales (MoCA) 3/4
4.2) Education and Cognition: Montreal Cognitive Assessment (MoCA).
Minimum score: 0
Maximum score: 30
Normal score: 26-30
Probable Neurocognitive Dissorder: 0-25
*Higher scores mean a better outcome.
Measured: Change from Baseline score at month 1 post treatment
Psychometric self-assessment scales (MoCA) 4/4
4.3) Education and Cognition: Montreal Cognitive Assessment (MoCA).
Minimum score: 0
Maximum score: 30
Normal score: 26-30
Probable Neurocognitive Dissorder: 0-25
*Higher scores mean a better outcome.
Measured: Change from Baseline score at month 2 post treatment
Psychometric self-assessment scales (WHOQOL-BREF) 1/4
5.0) Quality of life: WHOQOL-BREF (World Health Organization Quality of Life-BREF).
Minimum score: 0
Maximum score: 100
*Higher scores mean a better outcome.
Measured: Baseline score (1 month before TMS treatment)
Psychometric self-assessment scales (WHOQOL-BREF) 2/4
5.1) Quality of life: WHOQOL-BREF (World Health Organization Quality of Life-BREF).
Minimum score: 0
Maximum score: 100
*Higher scores mean a better outcome.
Measured: Change from Baseline score (immediately after the 12th session -last session-)
Psychometric self-assessment scales (WHOQOL-BREF) 3/4
5.2) Quality of life: WHOQOL-BREF (World Health Organization Quality of Life-BREF).
Minimum score: 0
Maximum score: 100
*Higher scores mean a better outcome.
Measured: Change from Baseline score at month 1 post treatment
Psychometric self-assessment scales (WHOQOL-BREF) 4/4
5.3) Quality of life: WHOQOL-BREF (World Health Organization Quality of Life-BREF).
Minimum score: 0
Maximum score: 100
*Higher scores mean a better outcome.
Measured: Change from Baseline score at month 2 post treatment
Psychometric self-assessment scales (King's) 1/4
6.0) King's Internalized Stigma Scale.
Minimum score: 0
Maximum score: 112
*Higher scores mean a worse outcome.
Measured: Baseline score (1 month before TMS treatment)
Psychometric self-assessment scales (King's) 2/4
6.1) King's Internalized Stigma Scale.
Minimum score: 0
Maximum score: 112
*Higher scores mean a worse outcome.
Measured: Change from Baseline score (immediately after the 12th session -last session-)
Psychometric self-assessment scales (King's) 3/4
6.2) King's Internalized Stigma Scale.
Minimum score: 0
Maximum score: 112
*Higher scores mean a worse outcome.
Measured: Change from Baseline score at month 1 post treatment
Psychometric self-assessment scales (King's) 4/4
6.3) King's Internalized Stigma Scale.
Minimum score: 0
Maximum score: 112
*Higher scores mean a worse outcome.
Measured: Change from Baseline score at month 2 post treatment
Psychometric self-assessment scales (OCI-R) 1/4
7.0) Obsessions/compulsions: The Obsessive-Compulsive Inventory Short Version (OCI-R)
Minimum score: 0
Maximum score: 72
*Higher scores mean a worse outcome.
Measured: Baseline score (1 month before TMS treatment)
Psychometric self-assessment scales (OCI-R) 2/4
7.1) Obsessions/compulsions: The Obsessive-Compulsive Inventory Short Version (OCI-R)
Minimum score: 0
Maximum score: 72
*Higher scores mean a worse outcome.
Measured: Change from Baseline score (immediately after the 12th session -last session-)
Psychometric self-assessment scales (OCI-R) 3/4
7.2) Obsessions/compulsions: The Obsessive-Compulsive Inventory Short Version (OCI-R)
Minimum score: 0
Maximum score: 72
*Higher scores mean a worse outcome.
Measured: Change from Baseline score at month 1 post treatment
Psychometric self-assessment scales (OCI-R) 4/4
7.3) Obsessions/compulsions: The Obsessive-Compulsive Inventory Short Version (OCI-R)
Minimum score: 0
Maximum score: 72
*Higher scores mean a worse outcome.
Measured: Change from Baseline score at month 2 post treatment
Psychometric self-assessment scales (BAI) 1/4
8.0) Beck Anxiety Inventory (BAI).
Minimum score: 0
Maximum score: 63
Minimal: 0 - 7
Mild: 8 - 15
Moderate: 16 - 25
Severe: 26 - 63
*Higher scores mean a worse outcome.
Measured: Baseline score (1 month before TMS treatment)
Psychometric self-assessment scales (BAI) 2/4
8.1) Beck Anxiety Inventory (BAI).
Minimum score: 0
Maximum score: 63
Minimal: 0 - 7
Mild: 8 - 15
Moderate: 16 - 25
Severe: 26 - 63
*Higher scores mean a worse outcome.
Measured: Change from Baseline score (immediately after the 12th session -last session-)
Psychometric self-assessment scales (BAI) 3/4
8.2) Beck Anxiety Inventory (BAI).
Minimum score: 0
Maximum score: 63
Minimal: 0 - 7
Mild: 8 - 15
Moderate: 16 - 25
Severe: 26 - 63
*Higher scores mean a worse outcome.
Measured: Change from Baseline score at month 1 post treatment
Psychometric self-assessment scales (BAI) 4/4
8.3) Beck Anxiety Inventory (BAI).
Minimum score: 0
Maximum score: 63
Minimal: 0 - 7
Mild: 8 - 15
Moderate: 16 - 25
Severe: 26 - 63
*Higher scores mean a worse outcome.
Measured: Change from Baseline score at month 2 post treatment
Psychometric self-assessment scales (HADS) 1/4
9.0) Anxiety: Hospital Anxiety and Depression Scale (HADS).
Depression (D):
Minimum score: 0
Maximum score: 21
Anxiety (A):
Minimum score: 0
Maximum score: 21
*Higher scores mean a worse outcome.
Measured: Baseline score (1 month before TMS treatment)
Psychometric self-assessment scales (HADS) 2/4
9.1) Anxiety: Hospital Anxiety and Depression Scale (HADS).
Depression (D):
Minimum score: 0
Maximum score: 21
Anxiety (A):
Minimum score: 0
Maximum score: 21
*Higher scores mean a worse outcome.
Measured: Change from Baseline score (immediately after the 12th session -last session-)
Psychometric self-assessment scales (HADS) 3/4
9.2) Anxiety: Hospital Anxiety and Depression Scale (HADS).
Depression (D):
Minimum score: 0
Maximum score: 21
Anxiety (A):
Minimum score: 0
Maximum score: 21
*Higher scores mean a worse outcome.
Measured: Change from Baseline score at month 1 post treatment
Psychometric self-assessment scales (HADS) 4/4
9.3) Anxiety: Hospital Anxiety and Depression Scale (HADS).
Depression (D):
Minimum score: 0
Maximum score: 21
Anxiety (A):
Minimum score: 0
Maximum score: 21
*Higher scores mean a worse outcome.
Measured: Change from Baseline score at month 2 post treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Feb 202231 Jul 2023

First posted15 Feb 2022
Study start14 Feb 2022
Primary completion20 May 2023
Study completion31 Jul 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (15)Papers the sponsor has linked to this study.
Other trials for Psychogenic Non-Epileptic SeizureStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: 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.
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 28 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05241366
Sponsor's protocol ID: 16/21
Status last verified: Sep 2023
First submitted: 20 Jan 2022
Last updated: 28 Sep 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 31125954
LaFrance, W., & Blumer, D. (2018). Pharmacological Treatments for Psychogenic Nonepileptic Seizures. University of Warwick. Retrieved from: https://www.cambridge.org/core.
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.
PubMed 20739647
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.
PubMed 10966532
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.
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.
PubMed 29628295
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.
PubMed 10880289
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.
PubMed 21195031
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.
PubMed 29588959
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.
PubMed 23303960
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.
PubMed 21480152
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.
PubMed 22056967
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.
PubMed 24703187
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.
PubMed 25306083
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.
PubMed 32690794

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingEarly Phase 1
Accelerated TMS for Seizure-Type Functional Neurologic Disorders
Functional Neurological Symptom Disorder, Functional Seizures
Recruiting
Modulating Movement Intention Via Cortical Stimulation
Seizures, Seizure Disorder
Recruiting
Retraining and Control Therapy (ReACT): Sense of Control and Symptom Expectations as Targets of a Treatment for PNES
Convulsion, Non-Epileptic
RecruitingPhase 1/2
Effects of a Sigle Dose of Ayahuasca in Patients With Psychogenic Non-epileptic Seizures: an Open Label Clinical Trial
Non Epileptic Seizures
Active, not recruitingObservational study
Study on the Rapid Diagnostic Value of Sudden Clap Provocation Test in Psychogenic Nonepileptic Seizures
Epilepsy, Psychogenic Non-epileptic Seizures

All Psychogenic Non-Epileptic Seizure trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Controlled Clinical Trial of Transcranial Magnetic Stimulation Versus Conventional Therapy for the Treatment of Functional Neurological Non-Epileptic Seizure Disorder: A Pilot Study
ClinicalTrials.gov ID: NCT05241366
Acronym / sponsor ID: 16/21
Conditions: Psychogenic Non-Epileptic Seizure
Keywords: Transcranial Magnetic Stimulation, Selective Serotonin Reuptake Inhibitor, Functional Neurological Disorder
Study type: Interventional
Recruitment status: Completed
Enrolment: 28 participants (actual)
Lead sponsor: El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco SuarezUniversity, hospital or other
Study start: 14 Feb 2022 (actual)
Primary completion: 20 May 2023 (actual)
Study completion: 31 Jul 2023 (actual)
First posted: 15 Feb 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2
Model description: 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.

Arm	Type	Receives
Transcranial Magnetic Stimulation + usual treatment with SSRIs	Experimental	Device: Transcranial Magnetic StimulationTranscranial 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.
Sham TMS coil + usual treatment with SSRIs	Sham comparator	Device: Sham Transcranial Magnetic Stimulation coilThe 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.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (7 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Transcranial Magnetic StimulationAlso: rTMSThe 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.	Device	Transcranial Magnetic Stimulation + usual treatment with SSRIs
Sham Transcranial Magnetic Stimulation coilAlso: Sham TMS coilSimulated 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.	Device	Sham TMS coil + usual treatment with SSRIs

Primary outcome

PNES count (1/4)
Time frame: Baseline PNES count (Starting 1 month before TMS treatment)
Participants in both groups will registered in a specific chart, daily psychogenic non-epileptic seizure activity.
PNES count (2/4)
Time frame: Change from Baseline PNES count (immediately after the session 12th -last session-)
Participants in both groups will registered in a specific chart, daily psychogenic non-epileptic seizure activity.
PNES count (3/4)
Time frame: Change from Baseline PNES count at month 1 post treatment
Participants in both groups will registered in a specific chart, daily psychogenic non-epileptic seizure activity.
PNES count (4/4)
Time frame: Change from Baseline PNES count at month 2 post treatment
Participants in both groups will registered in a specific chart, daily psychogenic non-epileptic seizure activity.

36 secondary outcomes

Psychometric self-assessment scales (BDI-II) 1/4
Time frame: Baseline score (1 month before TMS treatment)
Psychometric self-assessment scales (BDI-II) 2/4
Time frame: Change from Baseline score (immediately after the 12th session -last session-)
Psychometric self-assessment scales (BDI-II) 3/4
Time frame: Change from Baseline score at month 1 post treatment
Psychometric self-assessment scales (BDI-II) 4/4
Time frame: Change from Baseline score at month 2 post treatment
Psychometric self-assessment scales (DES) 1/4
Time frame: Baseline score (1 month before TMS treatment)
Psychometric self-assessment scales (DES) 2/4
Time frame: Change from Baseline score (immediately after the 12th session -last session-)
Psychometric self-assessment scales (DES) 3/4
Time frame: Change from Baseline score at month 1 post treatment
Psychometric self-assessment scales (DES) 4/4
Time frame: Change from Baseline score at month 2 post treatment
Psychometric self-assessment scales (PTSD) 1/4
Time frame: Baseline score (1 month before TMS treatment)
Psychometric self-assessment scales (PTSD) 2/4
Time frame: Change from Baseline score (immediately after the 12th session -last session-)
Psychometric self-assessment scales (PTSD) 3/4
Time frame: Change from Baseline score at month 1 post treatment
Psychometric self-assessment scales (PTSD) 4/4
Time frame: Change from Baseline score at month 2 post treatment
Psychometric self-assessment scales (MoCA) 1/4
Time frame: Baseline score (1 month before TMS treatment)
Psychometric self-assessment scales (MoCA) 2/4
Time frame: Change from Baseline score (immediately after the 12th session -last session-)
Psychometric self-assessment scales (MoCA) 3/4
Time frame: Change from Baseline score at month 1 post treatment
Psychometric self-assessment scales (MoCA) 4/4
Time frame: Change from Baseline score at month 2 post treatment
Psychometric self-assessment scales (WHOQOL-BREF) 1/4
Time frame: Baseline score (1 month before TMS treatment)
Psychometric self-assessment scales (WHOQOL-BREF) 2/4
Time frame: Change from Baseline score (immediately after the 12th session -last session-)
Psychometric self-assessment scales (WHOQOL-BREF) 3/4
Time frame: Change from Baseline score at month 1 post treatment
Psychometric self-assessment scales (WHOQOL-BREF) 4/4
Time frame: Change from Baseline score at month 2 post treatment
Psychometric self-assessment scales (King's) 1/4
Time frame: Baseline score (1 month before TMS treatment)
Psychometric self-assessment scales (King's) 2/4
Time frame: Change from Baseline score (immediately after the 12th session -last session-)
Psychometric self-assessment scales (King's) 3/4
Time frame: Change from Baseline score at month 1 post treatment
Psychometric self-assessment scales (King's) 4/4
Time frame: Change from Baseline score at month 2 post treatment
Psychometric self-assessment scales (OCI-R) 1/4
Time frame: Baseline score (1 month before TMS treatment)
Psychometric self-assessment scales (OCI-R) 2/4
Time frame: Change from Baseline score (immediately after the 12th session -last session-)
Psychometric self-assessment scales (OCI-R) 3/4
Time frame: Change from Baseline score at month 1 post treatment
Psychometric self-assessment scales (OCI-R) 4/4
Time frame: Change from Baseline score at month 2 post treatment
Psychometric self-assessment scales (BAI) 1/4
Time frame: Baseline score (1 month before TMS treatment)
Psychometric self-assessment scales (BAI) 2/4
Time frame: Change from Baseline score (immediately after the 12th session -last session-)
Psychometric self-assessment scales (BAI) 3/4
Time frame: Change from Baseline score at month 1 post treatment
Psychometric self-assessment scales (BAI) 4/4
Time frame: Change from Baseline score at month 2 post treatment
Psychometric self-assessment scales (HADS) 1/4
Time frame: Baseline score (1 month before TMS treatment)
Psychometric self-assessment scales (HADS) 2/4
Time frame: Change from Baseline score (immediately after the 12th session -last session-)
Psychometric self-assessment scales (HADS) 3/4
Time frame: Change from Baseline score at month 1 post treatment
Psychometric self-assessment scales (HADS) 4/4
Time frame: Change from Baseline score at month 2 post treatment

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
Background: PubMed 31125954Agarwal 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.
BackgroundLaFrance, W., & Blumer, D. (2018). Pharmacological Treatments for Psychogenic Nonepileptic Seizures. University of Warwick. Retrieved from: https://www.cambridge.org/core.
Background: PubMed 20739647LaFrance 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.
Background: PubMed 10966532Varia 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.
BackgroundPeterson, 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: PubMed 29628295Peterson 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.
Background: PubMed 10880289Benbadis 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.
Background: PubMed 21195031Duncan 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.
Background: PubMed 29588959Kanemoto 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.
Background: PubMed 23303960Pollak 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.
Background: PubMed 21480152Dafotakis 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.
Background: PubMed 22056967van 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.
Individual participant dataSharing planned: No

Related trials for Psychogenic Non-Epileptic Seizure

RecruitingEarly Phase 1
Accelerated TMS for Seizure-Type Functional Neurologic Disorders
Functional Neurological Symptom Disorder, Functional Seizures
Recruiting
Modulating Movement Intention Via Cortical Stimulation
Seizures, Seizure Disorder
Recruiting
Retraining and Control Therapy (ReACT): Sense of Control and Symptom Expectations as Targets of a Treatment for PNES
Convulsion, Non-Epileptic
RecruitingPhase 1/2
Effects of a Sigle Dose of Ayahuasca in Patients With Psychogenic Non-epileptic Seizures: an Open Label Clinical Trial
Non Epileptic Seizures
Active, not recruitingObservational study
Study on the Rapid Diagnostic Value of Sudden Clap Provocation Test in Psychogenic Nonepileptic Seizures
Epilepsy, Psychogenic Non-epileptic Seizures

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Édgar Daniel Crail Meléndez, MD principal investigator

Instituto Nacional de Neurología y Neurocirugía Manuel Velasco Suárez

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PNES count (1/4) (time frame: Baseline PNES count (Starting 1 month before TMS treatment)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05241366, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023.