Status:
COMPLETED
Non-invasive Intermittent Theta Burst Stimulation of the Dorsolateral Prefrontal Cortex in People With Functional Movement Disorders
Lead Sponsor:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Movement Disorders
Eligibility:
All Genders
18-65 years
Brief Summary
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 w...
Detailed Description
Objectives: The purpose of this protocol is to investigate feasibility and safety of intermittent theta burst stimulation (iTBS) targeting the left dorsolateral prefrontal cortex (DLPFC) in patients ...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Diagnosis of clinically definite functional movement disorder (as made by a neurologist)
- Ability to give informed consent
- Male and female participants between 18- 65 years of age
- Participation in protocol 07-N-0190
- Right handed (self-report)
- Ability to comply with all study procedures
- Abstinence from alcohol for at least 48 hrs prior to the study and caffeine on the day ofthe study (based on oral interview)
- EXCLUSION CRITERIA:
- 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)
Exclusion
Key Trial Info
Start Date :
March 29 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 5 2020
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT03263013
Start Date
March 29 2018
End Date
February 5 2020
Last Update
July 22 2021
Active Locations (1)
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1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892