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
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
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
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
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