Non-invasive Intermittent Theta Burst Stimulation of the Dorsolateral

Status Recruiting

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

Clinical Trial Details

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

View Details

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
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

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms