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Treating Non-epileptic Seizures Using Magnetic Brain Stimulation

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ClinicalTrials.gov Identifier: NCT02796924
Recruitment Status : Enrolling by invitation
First Posted : June 13, 2016
Last Update Posted : December 4, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. Mandana Modirrousta, 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.

Condition or disease Intervention/treatment Phase
Nonepileptic Seizures Device: MagStim Rapid2 Transcranial Magnetic Simulation Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Efficacy of Transcranial Magnetic Stimulation in the Treatment of Non-epileptic Seizures
Actual Study Start Date : June 2016
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Seizures

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




Primary Outcome Measures :
  1. Change in psychogenic non-epileptic seizure-related symptoms [ Time Frame: One week pre- and one week post-rTMS treatment ]
    Symptoms will be assessed using the electronic questionnaires one week prior to the first rTMS session and one week post-treatment.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02796924


Sponsors and Collaborators
University of Manitoba
Investigators
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Principal Investigator: Mandana Modirrousta, MD PhD FRCPC University of Manitoba

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Responsible Party: Dr. Mandana Modirrousta, Assistant Professor, University of Manitoba
ClinicalTrials.gov Identifier: NCT02796924     History of Changes
Other Study ID Numbers: B2016:039
First Posted: June 13, 2016    Key Record Dates
Last Update Posted: December 4, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Dr. Mandana Modirrousta, University of Manitoba:
Psychogenic Non-Epileptic Seizure
Transcranial Magnetic Stimulation
Brain Stimulation

Additional relevant MeSH terms:
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Seizures
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms