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Behavioural and Electrophysiological Effects of rTMS in Functional Neurological Disorders

Primary Purpose

Functional Neurological Disorder

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
MagStim Rapid2 Transcranial Magnetic Simulation
Sponsored by
University of Manitoba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Functional Neurological Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • St. Boniface Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Repetitive Transcranial Magnetic Stimulation (rTMS)

Arm Description

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.

Outcomes

Primary Outcome Measures

Change in relative timing of intention-to-act vs action production
Assessment of change in the lag time between intended and actual action production during pointing and stimulus response tasks.
Change in resting state activity in temporal-parietal junction brain region
Assessment of changes in EEG brain activity readings when participants are at rest at various frequencies, primarily targeting delta/theta bands.

Secondary Outcome Measures

Change in brain activity related to 'intention to act'
Assessment of changes in ERP waveform amplitude related to the 'intention to act' time-stamp during the movement task.
Change in brain activity related to motor production
Assessment of changes in ERP waveform amplitude related to the 'motor production' time-stamp during the movement task.

Full Information

First Posted
June 11, 2021
Last Updated
March 29, 2023
Sponsor
University of Manitoba
Collaborators
University of Winnipeg
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1. Study Identification

Unique Protocol Identification Number
NCT04942600
Brief Title
Behavioural and Electrophysiological Effects of rTMS in Functional Neurological Disorders
Official Title
Assessing the Behavioural and Electrophysiological Effects of Repetitive Transcranial Magnetic Stimulation on "Intention" vs "Overt Action" in Patients With Functional Neurological Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
January 14, 2022 (Actual)
Primary Completion Date
July 29, 2022 (Actual)
Study Completion Date
July 29, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Manitoba
Collaborators
University of Winnipeg

4. Oversight

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
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Neurological Disorder

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Repetitive Transcranial Magnetic Stimulation (rTMS)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
MagStim Rapid2 Transcranial Magnetic Simulation
Intervention Description
A non-invasive method of brain stimulation
Primary Outcome Measure Information:
Title
Change in relative timing of intention-to-act vs action production
Description
Assessment of change in the lag time between intended and actual action production during pointing and stimulus response tasks.
Time Frame
1 hour: Immediately prior to and following one session of rTMS
Title
Change in resting state activity in temporal-parietal junction brain region
Description
Assessment of changes in EEG brain activity readings when participants are at rest at various frequencies, primarily targeting delta/theta bands.
Time Frame
1 hour: Immediately prior to and following one session of rTMS
Secondary Outcome Measure Information:
Title
Change in brain activity related to 'intention to act'
Description
Assessment of changes in ERP waveform amplitude related to the 'intention to act' time-stamp during the movement task.
Time Frame
1 hour: Immediately prior to and following one session of rTMS
Title
Change in brain activity related to motor production
Description
Assessment of changes in ERP waveform amplitude related to the 'motor production' time-stamp during the movement task.
Time Frame
1 hour: Immediately prior to and following one session of rTMS

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruce Bolster, PhD
Organizational Affiliation
University of Winnipeg
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mandana Modirrousta, MD PhD
Organizational Affiliation
University of Manitoba
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Boniface Hospital
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R2H2A6
Country
Canada

12. IPD Sharing Statement

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Behavioural and Electrophysiological Effects of rTMS in Functional Neurological Disorders

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