Clinical Trials Logo

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.


Clinical Trial 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 ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05155059
Study type Interventional
Source National Institutes of Health Clinical Center (CC)
Contact Hyun Joo Cho, M.D.
Phone (301) 402-9336
Email hyunjoo.cho@nih.gov
Status Recruiting
Phase Phase 2
Start date May 6, 2022
Completion date July 1, 2031

See also
  Status Clinical Trial Phase
Completed NCT05861882 - ASSESSMENT OF THE HANDBALL PLAYERS
Active, not recruiting NCT06361615 - Effect of a Dual-task Intervention Program on Physical and Cognitive Function N/A
Terminated NCT02764476 - Embodied Virtual Reality Therapy for Functional Neurological Symptom/ Conversion Disorder N/A
Recruiting NCT05967078 - ExerG: Video Game-based Physical Cognitive Training for Patients: a Usability Study N/A
Not yet recruiting NCT06393439 - Virtual Reality in Functional Movement Disorder N/A
Not yet recruiting NCT06274281 - Digital Telerehabilitation in Functional Motor Disorders N/A
Active, not recruiting NCT03660098 - Mirror Box Therapy as a Treatment Option for Functional Movement Disorders
Completed NCT05634486 - Efficacy of the Multidisciplinary Treatment to the Quality of Life of With Functional Movement Disorders N/A
Not yet recruiting NCT06439017 - Passive Thoughts in Functional Movement Disorders
Active, not recruiting NCT03661021 - Study of the Ability of a New Technique to Effectively Diagnose Movement Disorders
Recruiting NCT06257069 - Tremor Retrainer Software Application for Functional Tremor N/A
Completed NCT03717376 - Movement Disorders and Early Maladaptive Schemas
Recruiting NCT06022393 - CBT Training for Cognitive Reappraisal as an Intervention for Patients With Functional Tremor - an EEG Study N/A
Recruiting NCT05345340 - Telemedicine in Functional Motor Disorder N/A