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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02796924
Other study ID # B2016:039
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 2016
Est. completion date September 2019

Study information

Verified date March 2020
Source University of Manitoba
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date September 2019
Est. primary completion date April 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
MagStim Rapid2 Transcranial Magnetic Simulation
A non-invasive method of brain stimulation

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Manitoba

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Weekly Psychogenic Non-epileptic Seizure-events Number of weekly seizure-events recorded using seizure logs. One week and three months post-rTMS treatment
See also
  Status Clinical Trial Phase
Completed NCT03138876 - EEG Cap for Identification of Non-Convulsive Status Epilepticus N/A