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

El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez

Status: Completed

Conditions: Psychogenic Non-Epileptic Seizure

Treatments: Device: Sham Transcranial Magnetic Stimulation coil; Device: Transcranial Magnetic Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT05241366

16/21

Details and patient eligibility

About

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).

Full 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.

Enrollment: 28 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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28 participants in 2 patient groups

Transcranial Magnetic Stimulation + usual treatment with SSRIs

Experimental group

Description:

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.

Treatment:

Device: Transcranial Magnetic Stimulation

Sham TMS coil + usual treatment with SSRIs

Sham Comparator group

Description:

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.

Treatment:

Device: Sham Transcranial Magnetic Stimulation coil