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

Completed

Conditions studied: Movement Disorders

In brief

Background: Functional movement disorder (FMD) causes involuntary movements, such as spasms, shaking, or jerks. These symptoms are not due to a recognized neurological or medical cause. Researchers want to better understand how the brain works to cause these symptoms. Objective: To test if intermittent theta burst stimulation (iTBS) affects brain areas involved in FMD symptoms. Also, to look at the effect of iTBS on mood and motor symptoms. Eligibility: Right-handed people ages 18-65 who have FMD and participated in protocol 07-N-0190 Design: Participants will have 4 visits. In Visit 1, participants will be screened with: Medical history Physical exam Urine test Questionnaires Visit 1 might also include a brain MRI and functional MRI. The MRI scanner is a cylinder surrounded by a strong magnetic field. They will lie on a table that can slide in and out of the cylinder. For the functional MRI, they will be asked to perform tasks during the MRI scan. Visit 2 will be 1-2 weeks after Visit 1. Visits 2, 3, and 4 will be no more than 48 hours apart. These include: Electromyography: Small electrodes are taped to the skin. Muscle activity is recorded while participants receive magnetic stimulation of the brain. Transcranial magnetic stimulation and iTBS: A wire coil is held on the scalp. A brief electrical current passes through the coil and creates a magnetic pulse to stimulate the brain. During iTBS, participants will sit quietly and watch a nature documentary. They will wear earplugs and a cap. MRI Functional MRI Questionnaires

Key facts

Study ID

NCT03263013

Run by

National Institute of Neurological Disorders and Stroke (NINDS)

People needed

7

Starts

2018-03-29

Expected to finish

2020-02-05

Last updated by the study team

2021-07-22

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• History of significant central nervous system disorders (primary or comorbid) such as neurodegenerative disorders, stroke, movement disorders, multiple sclerosis or epilepsy (clinical exam, MRI findings)
• History of psychotic disorder or bipolar disorder (clinical exam and/or SCID). Current acute mania and psychosis will also be excluded. As some degree of depressive symptoms is common in FMD patients, moderate unipolar depression will not be exclusionary (HAM-D score less than or equal to 18 will not be excluded)
• Current obsessive compulsive disorder (OCD) or post-traumatic stress disorder (PTSD)
• Active illicit substance use within the last 6 months (clinical exam and/or SCID).
• Current suicidal ideation (Columbia-Suicide Severity Rating Scale)
• Disease severity requiring inpatient treatment (clinical exam)
• Patients with movement symptoms at rest that may substantially inhibit resolution, comfort, or safety of MRI (clinical exam)
• Previous brain neurosurgery (self-reported history)
• History of head trauma that resulted in loss of consciousness for more than several seconds (self-reported history, TMS safety screening questionnaire, MRI findings)
• Regular use in the past 2 weeks of any of the following classes of medications: antiepileptics (except benzodiazepines, gabapentin and pregabalin), anti-parkinsonian medications, muscle relaxants, opiate medications and tricyclic antidepressants (selfreported history)
• Any history of seizures other than febrile childhood seizures (self-reported history)
• Family history of epilepsy (self-reported history, TMS safety screening)
• Patients with recurring fainting spells (self-reported history, TMS safety screening)
• Significant medical illness, including liver failure, kidney failure, congestive heart failure (clinical exam and/or medical records)
• Patients with documented hearing loss greater than or equal to 15dB at any frequency (medical records)
• Any psychiatric, medical or social condition whether or not listed above, 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.
• Breastfeeding (self-report)
• NINDS employee/staff
• Subjects who have contraindications to MRI (we will follow the NMR Center guidelines for MR safety). Some of the exclusions are:
• Have non-MRI compatible metal in the body, such as a cardiac pacemaker, brain stimulator, shrapnel, surgical metal, clips in the brain or on blood vessels, cochlear implants, artificial heart valves or ferromagnetic fragments in the eye or oral cavity as these make having an MRI unsafe.
• Unable to lie flat on the back for the expected length of the experiment (50 minutes).
• Have an abnormality on the brain imaging or neurologic examination not related to the diagnosis.
• Uncomfortable being in a small space for the expected length of the experiment (50 minutes).
• Non-removable body piercing or tattoo posing MRI risk
• Pregnancy (urine pregnancy test)

Where it is running

• National Institutes of Health Clinical Center — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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