TMS for Functional Movement Disorder
What You Need to Know Before You Apply
What is the purpose of this trial?
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 examQuestionnairesUrine testBrain 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.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking Buproprion (Wellbutrin).
Is theta burst stimulation (TBS) safe for humans?
Theta burst stimulation (TBS), including intermittent theta burst stimulation (iTBS), is generally considered safe for humans, with most adverse events being mild and occurring in about 5% of people. However, there is a theoretical risk of seizures, so it should be used with caution, and more research is needed to fully understand the safety of different stimulation settings.12345
How is Intermittent Theta Burst Stimulation (iTBS) different from other treatments for Functional Movement Disorder?
Intermittent Theta Burst Stimulation (iTBS) is unique because it is a form of repetitive transcranial magnetic stimulation (rTMS) that can be delivered in just over 3 minutes, making it much quicker than traditional rTMS sessions. It influences brain activity to help improve motor function, which may be beneficial for conditions like Functional Movement Disorder.12356
What data supports the effectiveness of the treatment Intermittent Theta Burst Stimulation (iTBS) for Functional Movement Disorder?
Intermittent Theta Burst Stimulation (iTBS) has shown effectiveness in improving motor function in conditions like Parkinson's disease and multiple sclerosis, and it is also used for treating depression. This suggests it may help with movement disorders by influencing brain activity related to motor control.12578
Who Is on the Research Team?
Debra J Ehrlich, M.D.
Principal Investigator
National Institute of Neurological Disorders and Stroke (NINDS)
Are You a Good Fit for This Trial?
This trial is for adults aged 18-80 diagnosed with Functional Movement Disorder (FMD) by a neurologist. Participants must be willing to follow the study procedures, not have significant neurological disorders other than FMD, no current psychosis or active suicidal thoughts, and not be pregnant.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline
Participants undergo neurological exam, questionnaires, urine test, and brain MRI
Treatment
Participants receive 5 daily sessions of TMS, either active or sham
Follow-up
Participants' FMD symptoms are evaluated and health questionnaires are completed
What Are the Treatments Tested in This Trial?
Interventions
- Intermittent Theta Burst Stimulation
Intermittent Theta Burst Stimulation is already approved in United States, European Union for the following indications:
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Who Is Running the Clinical Trial?
National Institute of Neurological Disorders and Stroke (NINDS)
Lead Sponsor