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

Not Applicable

Completed

• Conditions: Psychogenic Non-Epileptic Seizure
• Interventions: Device: Transcranial Magnetic Stimulation; Device: Sham Transcranial Magnetic Stimulation coil

• Registration Number: NCT05241366
• Lead Sponsor: El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez

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).

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.

Study Timeline

• Study First Submitted: 2022-01-20
• Study First Submitted QC: 2022-02-11
• Study Start: 2022-02-14
• Study First Posted: 2022-02-15
• Primary Completion: 2023-05-20
• Study Completion: 2023-07-31
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-27
• Last Update Posted: 2023-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

1. 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.
2. Patients who have a record at the institute with the diagnosis of PNES.
3. Patients with an encephalic MRI.
4. Patients who give their written consent to participate in the protocol.
5. Patients who have not had any changes in the pharmacological treatment in the last 6 weeks.

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Transcranial Magnetic Stimulation + usual treatment with SSRIs	Transcranial Magnetic Stimulation	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.
Sham TMS coil + usual treatment with SSRIs	Sham Transcranial Magnetic Stimulation coil	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.

Primary Outcome Measures

Name	Time	Method
PNES count (2/4)	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 (4/4)	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.
PNES count (1/4)	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 (3/4)	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.

Secondary Outcome Measures

Name	Time	Method
Psychometric self-assessment scales (BDI-II) 3/4	Change from Baseline score at month 1 post treatment	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.
Psychometric self-assessment scales (DES) 3/4	Change from Baseline score at month 1 post treatment	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.
Psychometric self-assessment scales (WHOQOL-BREF) 3/4	Change from Baseline score at month 1 post treatment	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.
Psychometric self-assessment scales (OCI-R) 4/4	Change from Baseline score at month 2 post treatment	7.3) Obsessions/compulsions: The Obsessive-Compulsive Inventory Short Version (OCI-R); Minimum score: 0; Maximum score: 72; \*Higher scores mean a worse outcome.
Psychometric self-assessment scales (BAI) 1/4	Baseline score (1 month before TMS treatment)	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.
Psychometric self-assessment scales (DES) 1/4	Baseline score (1 month before TMS treatment)	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.
Psychometric self-assessment scales (PTSD) 3/4	Change from Baseline score at month 1 post treatment	3.2) PTSD/Trauma/Resilience: PTSD Symptom Severity Scale.; Minimum score: 0; Maximum score: 80; \*Higher scores mean a worse outcome.
Psychometric self-assessment scales (WHOQOL-BREF) 2/4	Change from Baseline score (immediately after the 12th session -last session-)	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.
Psychometric self-assessment scales (King's) 3/4	Change from Baseline score at month 1 post treatment	6.2) King's Internalized Stigma Scale.; Minimum score: 0; Maximum score: 112; \*Higher scores mean a worse outcome.
Psychometric self-assessment scales (BDI-II) 1/4	Baseline score (1 month before TMS treatment)	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.
Psychometric self-assessment scales (BDI-II) 4/4	Change from Baseline score at month 2 post treatment	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.
Psychometric self-assessment scales (MoCA) 1/4	Baseline score (1 month before TMS treatment)	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.
Psychometric self-assessment scales (WHOQOL-BREF) 1/4	Baseline score (1 month before TMS treatment)	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.
Psychometric self-assessment scales (WHOQOL-BREF) 4/4	Change from Baseline score at month 2 post treatment	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.
Psychometric self-assessment scales (OCI-R) 1/4	Baseline score (1 month before TMS treatment)	7.0) Obsessions/compulsions: The Obsessive-Compulsive Inventory Short Version (OCI-R); Minimum score: 0; Maximum score: 72; \*Higher scores mean a worse outcome.
Psychometric self-assessment scales (OCI-R) 3/4	Change from Baseline score at month 1 post treatment	7.2) Obsessions/compulsions: The Obsessive-Compulsive Inventory Short Version (OCI-R); Minimum score: 0; Maximum score: 72; \*Higher scores mean a worse outcome.
Psychometric self-assessment scales (DES) 2/4	Change from Baseline score (immediately after the 12th session -last session-)	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.
Psychometric self-assessment scales (DES) 4/4	Change from Baseline score at month 2 post treatment	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.
Psychometric self-assessment scales (PTSD) 2/4	Change from Baseline score (immediately after the 12th session -last session-)	3.1) PTSD/Trauma/Resilience: PTSD Symptom Severity Scale.; Minimum score: 0; Maximum score: 80; \*Higher scores mean a worse outcome.
Psychometric self-assessment scales (BDI-II) 2/4	Change from Baseline score (immediately after the 12th session -last session-)	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.
Psychometric self-assessment scales (PTSD) 1/4	Baseline score (1 month before TMS treatment)	3.0) PTSD/Trauma/Resilience: PTSD Symptom Severity Scale.; Minimum score: 0; Maximum score: 80; \*Higher scores mean a worse outcome.
Psychometric self-assessment scales (PTSD) 4/4	Change from Baseline score at month 2 post treatment	3.3) PTSD/Trauma/Resilience: PTSD Symptom Severity Scale.; Minimum score: 0; Maximum score: 80; \*Higher scores mean a worse outcome.
Psychometric self-assessment scales (MoCA) 2/4	Change from Baseline score (immediately after the 12th session -last session-)	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.
Psychometric self-assessment scales (MoCA) 4/4	Change from Baseline score at month 2 post treatment	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.
Psychometric self-assessment scales (King's) 2/4	Change from Baseline score (immediately after the 12th session -last session-)	6.1) King's Internalized Stigma Scale.; Minimum score: 0; Maximum score: 112; \*Higher scores mean a worse outcome.
Psychometric self-assessment scales (OCI-R) 2/4	Change from Baseline score (immediately after the 12th session -last session-)	7.1) Obsessions/compulsions: The Obsessive-Compulsive Inventory Short Version (OCI-R); Minimum score: 0; Maximum score: 72; \*Higher scores mean a worse outcome.
Psychometric self-assessment scales (HADS) 2/4	Change from Baseline score (immediately after the 12th session -last session-)	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.
Psychometric self-assessment scales (MoCA) 3/4	Change from Baseline score at month 1 post treatment	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.
Psychometric self-assessment scales (King's) 1/4	Baseline score (1 month before TMS treatment)	6.0) King's Internalized Stigma Scale.; Minimum score: 0; Maximum score: 112; \*Higher scores mean a worse outcome.
Psychometric self-assessment scales (King's) 4/4	Change from Baseline score at month 2 post treatment	6.3) King's Internalized Stigma Scale.; Minimum score: 0; Maximum score: 112; \*Higher scores mean a worse outcome.
Psychometric self-assessment scales (BAI) 2/4	Change from Baseline score (immediately after the 12th session -last session-)	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.
Psychometric self-assessment scales (BAI) 3/4	Change from Baseline score at month 1 post treatment	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.
Psychometric self-assessment scales (BAI) 4/4	Change from Baseline score at month 2 post treatment	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.
Psychometric self-assessment scales (HADS) 1/4	Baseline score (1 month before TMS treatment)	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.
Psychometric self-assessment scales (HADS) 4/4	Change from Baseline score at month 2 post treatment	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.
Psychometric self-assessment scales (HADS) 3/4	Change from Baseline score at month 1 post treatment	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.

Trial Locations

Locations (1)

Instituto Nacional de Neurologia Y Neurocirugia Mvs; 🇲🇽 Mexico, Ciudad De Mexico, Mexico