Behavioural and Electrophysiological Effects of rTMS in Functional Neurological Disorders

NCT04942600 | Completed

• 1 other identifier: HS24851 (B2021:033)
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Functional Neurological Disorder

Outcome Measures

Primary Outcomes (2)

• 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.

  1 hour: Immediately prior to and following one session of rTMS

• 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.

  1 hour: Immediately prior to and following one session of rTMS

Secondary Outcomes (2)

• Change in brain activity related to 'intention to act'

  1 hour: Immediately prior to and following one session of rTMS

• Change in brain activity related to motor production

  1 hour: Immediately prior to and following one session of rTMS

Study Arms (1)

Repetitive Transcranial Magnetic Stimulation (rTMS)

EXPERIMENTAL

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

Interventions

MagStim Rapid2 Transcranial Magnetic Simulation DEVICE

A non-invasive method of brain stimulation

Repetitive Transcranial Magnetic Stimulation (rTMS)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed diagnosis of Functional Neurological Disorder with motor symptoms.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Manitoba: lead
• University of Winnipeg: collaborator

Study Sites (1)

St. Boniface Hospital

Winnipeg, Manitoba, R2H2A6, Canada

Location

MeSH Terms

Conditions

Conversion Disorder

Condition Hierarchy (Ancestors)

Somatoform Disorders; Mental Disorders

Study Officials

• Bruce Bolster, PhD

  University of Winnipeg

  PRINCIPAL INVESTIGATOR

• Mandana Modirrousta, MD PhD

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2021
• First Posted: June 28, 2021
• Study Start: January 14, 2022
• Primary Completion: July 29, 2022
• Study Completion: July 29, 2022
• Last Updated: March 31, 2023

Record last verified: 2023-03

Locations

CA (1)