Behavioural and Electrophysiological Effects of rTMS in Functional Neurological Disorders

Sponsor
University of Manitoba (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04942600
Collaborator
University of Winnipeg (Other)
50
1
1
16.9
3

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: MagStim Rapid2 Transcranial Magnetic Simulation
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Assessing the Behavioural and Electrophysiological Effects of Repetitive Transcranial Magnetic Stimulation on "Intention" vs "Overt Action" in Patients With Functional Neurological Disorders
Anticipated Study Start Date :
Nov 1, 2021
Anticipated Primary Completion Date :
Aug 26, 2022
Anticipated Study Completion Date :
Mar 31, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Change in relative timing of intention-to-act vs action production [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.

  2. Change in resting state activity in temporal-parietal junction brain region [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.

Secondary Outcome Measures

  1. Change in brain activity related to 'intention to act' [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.

  2. Change in brain activity related to motor production [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 St. Boniface Hospital Winnipeg Manitoba Canada R2H2A6

Sponsors and Collaborators

  • University of Manitoba
  • University of Winnipeg

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Manitoba
ClinicalTrials.gov Identifier:
NCT04942600
Other Study ID Numbers:
  • HS24851 (B2021:033)
First Posted:
Jun 28, 2021
Last Update Posted:
Oct 4, 2021
Last Verified:
Jun 1, 2021
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 4, 2021