NCT02796924

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2016

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

June 3, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 13, 2016

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

September 30, 2020

Completed
Last Updated

September 30, 2020

Status Verified

March 1, 2020

Enrollment Period

2.8 years

First QC Date

June 3, 2016

Results QC Date

September 8, 2020

Last Update Submit

September 8, 2020

Conditions

Nonepileptic Seizures

Keywords

Psychogenic Non-Epileptic SeizureTranscranial Magnetic StimulationBrain Stimulation

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Patients

EXPERIMENTAL

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

Interventions

MagStim Rapid2 Transcranial Magnetic SimulationDEVICE

A non-invasive method of brain stimulation

Patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Confirmed Psychogenic Non-Epileptic Seizures

You may not qualify if:

  • Evidence of previous or comorbid epileptic seizures
  • Major comorbid neurological diseases
  • Currently taking medications that are known to reduce seizure-threshold
  • Currently pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

SeizuresPsychogenic Nonepileptic Seizures

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Dr. Mandana Modirrousta
Organization
University of Manitoba
mmodirrousta@sbgh.mb.ca
2042372303

Study Officials

  • Mandana Modirrousta, MD PhD FRCPC

    University of Manitoba

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 3, 2016

First Posted

June 13, 2016

Study Start

June 1, 2016

Primary Completion

April 1, 2019

Study Completion

September 1, 2019

Last Updated

September 30, 2020

Results First Posted

September 30, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share