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Completed

NCT Number: NCT04942600

Behavioural and Electrophysiological Effects of rTMS in 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Boniface Hospital

Winnipeg, Manitoba, R2H2A6, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MagStim Rapid2 Transcranial Magnetic Simulation

Device

A non-invasive method of brain stimulation

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

University of Manitoba

Other

Collaborators

  • University of Winnipeg

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jun 28, 2021
Registry last updated
Mar 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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