Non-invasive Intermittent Theta Burst Stimulation of the Dorsolateral Prefrontal Cortex in Functional Movement Disorders

NCT05155059 | Active Not Recruiting Phase 2

• 2 other identifiers: 10000642000642-N
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Functional movement disorders (FMD) involve involuntary movements that are not due to a recognized neurological or medical cause. FMD can cause major disability. Researchers want to learn more to create better treatments for FMD. Objective: To test whether non-invasive brain stimulation using transcranial magnetic stimulation (TMS) improves FMD symptoms. Eligibility: People between the ages of 18 and 80 who have been diagnosed with FMD by a neurologist. Design: Participants will be randomly assigned to one of two groups. One group is an active brain stimulation group and the other is a sham brain stimulation group. Participants will have a baseline visit. This will include: Neurological exam Questionnaires Urine test Brain MRI: Participants will lie in a machine that takes pictures of the body. They will be asked to respond to images on a screen while in the scanner. Within 2 weeks of the baseline visit, participants will begin 5 daily sessions of TMS. The active group will have stimulation delivered to the brain via a coil. In the sham group, a dummy coil will be used that will not deliver stimulation. A total of three 3-minute cycles will be done in one visit. There will be 20-minute breaks between the cycles. Participants will have visits 1 month, 2 months, and 6 months after their last day of TMS. Their FMD symptoms will be evaluated. They will complete health questionnaires. These visits can be in person or virtual.

Conditions

Functional Movement Disorder

Keywords

Functional Movement Disorders; Transcranial Magnetic Stimulation (TMS); iTBS; Repetitive Transcranial Magnetic Stimulation; Neuroimaging; Conversion Disorder

Outcome Measures

Primary Outcomes (1)

• S-FMDRS

  Short version of Functional Movement Disorder Rating Scale

  1 month after iTBS

Secondary Outcomes (3)

• S-FMDRS

  2 and 6 months after iTBS

• SF-36

  1, 2 and 6 months after iTBS

• CGI

  1, 2 and 6 months after iTBS

Study Arms (2)

Control

SHAM COMPARATOR

Sham TMS stimulation using a sham coil

Other: Sham Comparator

Treatment

EXPERIMENTAL

Active TMS stimulation using an active TMS coil

Device: MagStim

Interventions

MagStim DEVICE

Bursts of three at 50Hz with an inter burst interval of 200 ms will be given for 190 seconds and this session will be repeated 3 times with 20 minutes between each session in one day. The set of 3 sessions will be repeated 5 times in 5 consecutive days.

Treatment

Sham Comparator OTHER

Sham TMS stimulation using a sham coil

Control

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• In order to be eligible to participate in this study, an individual must meet all of the following criteria:
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Male or female, aged 18-80
• Diagnosis of functional movement disorder made by a neurologist
• Agreement to adhere to Lifestyle Considerations throughout study duration
• Ability of subject to understand and the willingness to sign a written informed consent document.

You may not qualify if:

• An individual who meets any of the following criteria will be excluded from participation in this study:
• Current psychosis or active suicidal ideation
• History of epilepsy with the exception of febrile seizure
• Patients with psychogenic non-epileptic seizure without comcomitant functional movement disorder
• Any significant neurological disorders other than FMD including but not limited to multiple sclerosis, stroke, Parkinson s disease, space occupying brain lesion
• Alcohol or substance use disorder
• Patients who are on Buproprion (Wellbutrin)
• Patients with moderate to severe cardiac disease
• Any psychiatric, medical or social condition due to which, in the judgment of the PI and after any consults if indicated, participation in the study is not in the best interest of the patient.
• Pregnancy

Sponsors & Collaborators

• National Institute of Neurological Disorders and Stroke (NINDS): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Publications (1)

• Spagnolo PA, Parker J, Horovitz S, Hallett M. Corticolimbic Modulation via Intermittent Theta Burst Stimulation as a Novel Treatment for Functional Movement Disorder: A Proof-of-Concept Study. Brain Sci. 2021 Jun 15;11(6):791. doi: 10.3390/brainsci11060791.

  PMID: 34203993 BACKGROUND

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Conversion Disorder

Condition Hierarchy (Ancestors)

Somatoform Disorders; Mental Disorders

Study Officials

• Debra J Ehrlich, M.D.

  National Institute of Neurological Disorders and Stroke (NINDS)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2021
• First Posted: December 13, 2021
• Study Start: May 6, 2022
• Primary Completion: April 25, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 3, 2025

Record last verified: 2025-05-30

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: For 2 years after the publication
• Access Criteria: IPD can be shared with researchers who provide methodologically sound proposal for meta-analysis or any other scientific analysis. Requests should be directed to the study PI who will review requests. Only de-identified data will be shared for scientific purposes.

Locations

US (1)