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

Functional Movement Disorder Clinical Trial

Official title:

Phase II Trial of Non-Invasive Intermittent Theta Burst Stimulation of the Dorsolateral Prefrontal Cortex in Functional Movement Disorders

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05155059
• Other study ID #: 10000642
• Secondary ID: 000642-N
• Status: Recruiting
• Phase: Phase 2
• Start date: May 6, 2022
• Est. completion date: July 1, 2031

Study information

• Verified date: January 8, 2024
• Source: National Institutes of Health Clinical Center (CC)
• Contact: Hyun Joo Cho, M.D.
• Phone: (301) 402-9336
• Email: hyunjoo.cho[@]nih.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Study Description: The purpose of this protocol is to investigate efficacy of intermittent theta burst stimulation (iTBS) targeting the left dorsolateral prefrontal cortex (DLPFC) in patients with functional movement disorders (FMD). Participants will be randomly assigned to receive either active iTBS or sham stimulation of the left DLPFC for 5 consecutive daily sessions. Objectives: Primary Objective: To investigate efficacy of iTBS of the left DLPFC on motor symptoms in patients with FMD Secondary Objectives: To investigate efficacy of iTBS of the left DLPFC on mood symptoms and its effect on fronto-amygdala circuit on functional neuroimaging Endpoints: Primary Endpoint: Relative change in Functional Movement Disorder Rating Scale (S-FMDRS) from the baseline to 1 month after iTBS vs sham: 100 *( S-FMDRS at one-month S-FMDRS at baseline)/ S-FMDRS at baseline Secondary Endpoints: - S-FMDRS immediately after, 2 months and 6 months after the treatment - HADS at 1 month, 2 months and 6 months after the treatment - DLPFC-amygdala functional connectivity - Amygdala BOLD response to emotional stimuli

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: July 1, 2031
• Est. primary completion date: July 1, 2031
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

• INCLUSION CRITERIA:

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. EXCLUSION CRITERIA: 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

Related Conditions & MeSH terms

• Conversion Disorder
• Functional Movement Disorder
• Movement Disorders

Intervention

Device:
• MagStim
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.

Other:
• Sham Comparator
Sham TMS stimulation using a sham coil

Locations

Country	Name	City	State
United States	National Institutes of Health Clinical Center	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	S-FMDRS	Short version of Functional Movement Disorder Rating Scale	1 month after iTBS
Secondary	S-FMDRS	Short version of Functional Movement Disorder Rating Scale	2 and 6 months after iTBS
Secondary	SF-36	Health related quality of life	1, 2 and 6 months after iTBS
Secondary	CGI	Clinical Global impression - scale of 1-7 to measure clinical improvement from the intervention	1, 2 and 6 months after iTBS

External Links

•   NIH Clinical Center Detailed Web Page