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

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).

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.

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.