TMS vs Conventional Therapy for the Treatment of Functional Neurological Non Epileptic Seizure Disorder
Condition: Psychogenic Non-Epileptic Seizure
MeSH terms: Seizures; Epilepsy; Psychogenic Nonepileptic Seizures
Study type: Interventional

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.
    

Intervention name(s): Transcranial Magnetic Stimulation; Sham Transcranial Magnetic Stimulation coil
Intervention type(s): Device; Device
Intervention description(s): 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.; 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.
Other intervention name(s): rTMS; Sham TMS coil
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention 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 (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Transcranial Magnetic Stimulation; Selective Serotonin Reuptake Inhibitor; Functional Neurological Disorder