CompletedNot Applicable

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

Mexico28 participantsStarted 2022-02-14

Plain-language 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).

Who can participate

Age range18 Years – 65 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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.

What they're measuring

PNES count (1/4)

Timeframe: Baseline PNES count (Starting 1 month before TMS treatment)

PNES count (2/4)

Timeframe: Change from Baseline PNES count (immediately after the session 12th -last session-)

PNES count (3/4)

Timeframe: Change from Baseline PNES count at month 1 post treatment

PNES count (4/4)

Timeframe: Change from Baseline PNES count at month 2 post treatment

Trial details

NCT IDNCT05241366

SponsorEl Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-05-20

View on ClinicalTrials.gov More Psychogenic Non-Epileptic Seizure trials