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

National Institutes of Health (NIH)

Status and phase: Active, not recruiting; Phase 2

Conditions: Functional Movement Disorder

Treatments: Device: MagStim; Other: Sham Comparator

Study type: Interventional

Funder types: NIH

Identifiers

NCT05155059

10000642

000642-N

Details and patient eligibility

About

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.

Full 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

Enrollment: 21 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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21 participants in 2 patient groups

Control

Sham Comparator group

Description:

Sham TMS stimulation using a sham coil

Treatment:

Other: Sham Comparator

Treatment

Experimental group

Description:

Active TMS stimulation using an active TMS coil

Treatment:

Device: MagStim