Behavioural and Electrophysiological Effects of rTMS in Functional Neurological Disorders

Functional Neurological Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04942600
• Other study ID #: HS24851 (B2021:033)
• Status: Completed
• Phase: N/A
• Start date: January 14, 2022
• Est. completion date: July 29, 2022

Study information

• Verified date: March 2023
• Source: University of Manitoba
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: July 29, 2022
• Est. primary completion date: July 29, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Conversion Disorder
• Functional Neurological Disorder
• Nervous System Diseases

Intervention

Device:
• MagStim Rapid2 Transcranial Magnetic Simulation
A non-invasive method of brain stimulation

Locations

Country	Name	City	State
Canada	St. Boniface Hospital	Winnipeg	Manitoba

Sponsors (2)

Lead Sponsor	Collaborator
University of Manitoba	University of Winnipeg

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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.	1 hour: Immediately prior to and following one session of rTMS
Secondary	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.	1 hour: Immediately prior to and following one session of rTMS