Behavioural and Electrophysiological Effects of rTMS in Functional Neurological Disorders

NCT ID: NCT04942600

Last Updated: 2023-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-14

Study Completion Date

2022-07-29

Brief Summary

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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

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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.

Conditions

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Functional Neurological Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

MagStim Rapid2 Transcranial Magnetic Simulation

Intervention Type DEVICE

A non-invasive method of brain stimulation

Interventions

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MagStim Rapid2 Transcranial Magnetic Simulation

A non-invasive method of brain stimulation

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Winnipeg

UNKNOWN

Sponsor Role collaborator

University of Manitoba

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bruce Bolster, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Winnipeg

Mandana Modirrousta, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University of Manitoba

Locations

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St. Boniface Hospital

Winnipeg, Manitoba, Canada

Site Status

Countries

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Canada

Other Identifiers

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HS24851 (B2021:033)

Identifier Type: -

Identifier Source: org_study_id

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