search
Back to results

Treating Non-epileptic Seizures Using Magnetic Brain Stimulation

Primary Purpose

Nonepileptic Seizures

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
MagStim Rapid2 Transcranial Magnetic Simulation
Sponsored by
University of Manitoba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nonepileptic Seizures focused on measuring Psychogenic Non-Epileptic Seizure, Transcranial Magnetic Stimulation, Brain Stimulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Patients

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    Number of Weekly Psychogenic Non-epileptic Seizure-events
    Number of weekly seizure-events recorded using seizure logs.

    Secondary Outcome Measures

    Full Information

    First Posted
    June 3, 2016
    Last Updated
    September 8, 2020
    Sponsor
    University of Manitoba
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02796924
    Brief Title
    Treating Non-epileptic Seizures Using Magnetic Brain Stimulation
    Official Title
    The Efficacy of Transcranial Magnetic Stimulation in the Treatment of Non-epileptic Seizures
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2016 (Actual)
    Primary Completion Date
    April 2019 (Actual)
    Study Completion Date
    September 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Manitoba

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Nonepileptic Seizures
    Keywords
    Psychogenic Non-Epileptic Seizure, Transcranial Magnetic Stimulation, Brain Stimulation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    10 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Patients
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    MagStim Rapid2 Transcranial Magnetic Simulation
    Intervention Description
    A non-invasive method of brain stimulation
    Primary Outcome Measure Information:
    Title
    Number of Weekly Psychogenic Non-epileptic Seizure-events
    Description
    Number of weekly seizure-events recorded using seizure logs.
    Time Frame
    One week and three months post-rTMS treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mandana Modirrousta, MD PhD FRCPC
    Organizational Affiliation
    University of Manitoba
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Treating Non-epileptic Seizures Using Magnetic Brain Stimulation

    We'll reach out to this number within 24 hrs