Treating Non-epileptic Seizures Using Magnetic Brain Stimulation

Not Applicable

Completed

• Conditions: Nonepileptic Seizures
• Interventions: Device: MagStim Rapid2 Transcranial Magnetic Simulation

• Registration Number: NCT02796924
• Lead Sponsor: University of Manitoba

Brief Summary

The purpose of this study is to investigate the feasibility of using repetitive transcranial magnetic stimulation (rTMS) - a form of non-invasive brain stimulation - to decrease the frequency of psychogenic non-epileptic seizure (PNES) episodes in patients with PNES.

Detailed Description

This study is an open label pilot study that aims to recruit 15 individuals with diagnosed PNES to investigate the feasibility of using repetitive transcranial magnetic stimulation (rTMS) to decreasing the frequency of psychogenic non-epileptic seizure (PNES) episodes. rTMS is a non-invasive method of brain stimulation that uses rapid magnetic pulses applied over the scalp to active neurons in a specified target location of the brain.

Electronic as well as paper-and-pencil questionnaires will be used to asses patient's psychiatric symptoms and functional impairment both before and after treatment to monitor symptom-changes.Treatment will consist of daily sessions of high frequency (20 Hz) rTMS applied over the right temporoparietal junction (TPJ) of the cerebral cortex. Patients will receive two sessions per day for 15 consecutive weekdays. Each session will take approximately 20 minutes to complete.

Results of the questionnaires will be analyzed to determine the effect of the treatment on PNES episodes and functional impairment. As a pilot study, this research will be used to evaluate the effect size and the feasibility of a more definitive project in the future. Both patient response and tolerability to rTMS will be analyzed.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2016-06
• Study First Submitted: 2016-06-03
• Study First Submitted QC: 2016-06-07
• Study First Posted: 2016-06-13
• Primary Completion: 2019-04
• Study Completion: 2019-09
• Status Verified: 2020-03
• Results First Submitted: 2020-09-08
• Results First Submitted QC: 2020-09-08
• Last Update Submitted: 2020-09-08
• Results First Posted: 2020-09-30
• Last Update Posted: 2020-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Confirmed Psychogenic Non-Epileptic Seizures

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Exclusion Criteria

• Evidence of previous or comorbid epileptic seizures
• Major comorbid neurological diseases
• Currently taking medications that are known to reduce seizure-threshold
• Currently pregnant

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients	MagStim Rapid2 Transcranial Magnetic Simulation	30 sessions of high-frequency (20Hz) repetitive stimulation applied over the right temporal-parietal junction in patients with psychogenic non-epileptic seizures using a MagStim Rapid2 Transcranial Magnetic Simulation machine.

Primary Outcome Measures

Name	Time	Method
Number of Weekly Psychogenic Non-epileptic Seizure-events	One week and three months post-rTMS treatment	Number of weekly seizure-events recorded using seizure logs.