Treating Non-epileptic Seizures Using Magnetic Brain Stimulation

September 8, 2020 updated by: University of Manitoba

The Efficacy of Transcranial Magnetic Stimulation in the Treatment of Non-epileptic Seizures

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Confirmed Psychogenic Non-Epileptic Seizures

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Patients
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.
Device: MagStim Rapid2 Transcranial Magnetic Simulation
A non-invasive method of brain stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Weekly Psychogenic Non-epileptic Seizure-events
Time Frame: One week and three months post-rTMS treatment
Number of weekly seizure-events recorded using seizure logs.
One week and three months post-rTMS treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Manitoba

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 1, 2016

Primary Completion (ACTUAL)

April 1, 2019

Study Completion (ACTUAL)

September 1, 2019

Study Registration Dates

First Submitted

June 3, 2016

First Submitted That Met QC Criteria

June 7, 2016

First Posted (ESTIMATE)

June 13, 2016

Study Record Updates

Last Update Posted (ACTUAL)

September 30, 2020

Last Update Submitted That Met QC Criteria

September 8, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B2016:039

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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