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
|Condition or disease||Intervention/treatment||Phase|
|Nonepileptic Seizures||Device: MagStim Rapid2 Transcranial Magnetic Simulation||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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.
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
|Principal Investigator:||Mandana Modirrousta, MD PhD FRCPC||University of Manitoba|