Status:

COMPLETED

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

Lead Sponsor:

El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez

Conditions:

Psychogenic Non-Epileptic Seizure

Eligibility:

All Genders

18-65 years

Phase:

NA

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...

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 ea...

Eligibility Criteria

Inclusion

  • 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.

Exclusion

  • 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.

Key Trial Info

Start Date :

February 14 2022

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

July 31 2023

Estimated Enrollment :

28 Patients enrolled

Trial Details

Trial ID

NCT05241366

Start Date

February 14 2022

End Date

July 31 2023

Last Update

September 28 2023

Active Locations (1)

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Instituto Nacional de Neurologia Y Neurocirugia Mvs

Mexico City, Mexico City, Mexico, 14269