Behavioural and Electrophysiological Effects of rTMS in Functional Neurological Disorders

March 29, 2023 updated by: University of Manitoba

Assessing the Behavioural and Electrophysiological Effects of Repetitive Transcranial Magnetic Stimulation on "Intention" vs "Overt Action" in Patients With Functional Neurological Disorders

The purpose of this study is to better understand Functional Neurological Disorders (FND) by measuring movement timing and brain activity in patients with FND during deliberate movements and when expressing an 'intention' to move. This investigation will use non-invasive brain stimulation to investigate the role of the temporal-occipital-parietal junction in FND.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study seeks to improve our neurophysiological understanding of Functional Neurological Disorders (FND) by measuring movement timing and brain activity while individuals with FND perform a simple pointing task.

Behavioural (timing of arm and finger movement) and electrophysiological (electroencephalography; EEG) measures will be collected both at rest and while participants perform a voluntary movement task designed to discriminate between brain events related to intention vs. overt action.

Furthermore, this study will investigate the ability of a non-invasive brain stimulation technique called repetitive transcranial magnetic stimulation (rTMS) to alter brain activity in the temporal-occipital-parietal junction (TPJ), a region known to be hypo-active in individuals with FND. Tasks and cortical recordings will be repeated following rTMS to determine the effect of brain stimulation on behaviour and brain activity.

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R2H2A6
        • St. Boniface Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Confirmed diagnosis of Functional Neurological Disorder with motor symptoms.

Exclusion Criteria:

  • Presence of another comorbid psychiatric disorder;
  • Any contraindication for rTMS (e.g., implanted metal devices; cardiac pacemaker or pacemaker wires; neurostimulators; implanted pumps, metal in the body [rods, plates, screws, shrapnel, dentures, IUD] or metallic particles in the body, surgical clips in the head, previous neurosurgery, cochlear implants, prosthetic heart valves);
  • Currently pregnant.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Repetitive Transcranial Magnetic Stimulation (rTMS)
1 session (3,000 pulses) of high-frequency (10Hz) repetitive stimulation applied over the right temporal parietal junction (TPJ) gyrus in individuals with Functional Neurological Disorder using a MagStim Rapid2 Transcranial Magnetic Simulation machine.
Device: MagStim Rapid2 Transcranial Magnetic Simulation
A non-invasive method of brain stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in relative timing of intention-to-act vs action production
Time Frame: 1 hour: Immediately prior to and following one session of rTMS
Assessment of change in the lag time between intended and actual action production during pointing and stimulus response tasks.
1 hour: Immediately prior to and following one session of rTMS
Change in resting state activity in temporal-parietal junction brain region
Time Frame: 1 hour: Immediately prior to and following one session of rTMS
Assessment of changes in EEG brain activity readings when participants are at rest at various frequencies, primarily targeting delta/theta bands.
1 hour: Immediately prior to and following one session of rTMS

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in brain activity related to 'intention to act'
Time Frame: 1 hour: Immediately prior to and following one session of rTMS
Assessment of changes in ERP waveform amplitude related to the 'intention to act' time-stamp during the movement task.
1 hour: Immediately prior to and following one session of rTMS
Change in brain activity related to motor production
Time Frame: 1 hour: Immediately prior to and following one session of rTMS
Assessment of changes in ERP waveform amplitude related to the 'motor production' time-stamp during the movement task.
1 hour: Immediately prior to and following one session of rTMS

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Manitoba

Collaborators

University of Winnipeg

Investigators

  • Principal Investigator: Bruce Bolster, PhD, University of Winnipeg
  • Principal Investigator: Mandana Modirrousta, MD PhD, University of Manitoba

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 14, 2022

Primary Completion (Actual)

July 29, 2022

Study Completion (Actual)

July 29, 2022

Study Registration Dates

First Submitted

June 11, 2021

First Submitted That Met QC Criteria

June 25, 2021

First Posted (Actual)

June 28, 2021

Study Record Updates

Last Update Posted (Actual)

March 31, 2023

Last Update Submitted That Met QC Criteria

March 29, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HS24851 (B2021:033)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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