NCT05241366

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Psychogenic Non-Epileptic Seizure

Interventions

Type	Name	Description
DEVICE	Transcranial Magnetic Stimulation	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.
DEVICE	Sham Transcranial Magnetic Stimulation 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.

Timeline

• Start date: 2022-02-14
• Primary completion: 2023-05-20
• Completion: 2023-07-31
• First posted: 2022-02-15
• Last updated: 2023-09-28

Locations

1 site across 1 country: Mexico