NCT05155059

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

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: National Institute of Neurological Disorders and Stroke (NINDS) · NIH
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Functional Movement Disorder

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-05-06
• Primary completion: 2025-04-25
• Completion: 2026-12-01
• First posted: 2021-12-13
• Last updated: 2025-06-03

Locations

1 site across 1 country: United States