Non-invasive brain stimulation for treating functional movement disorders
Phase II Trial of Non-Invasive Intermittent Theta Burst Stimulation of the Dorsolateral Prefrontal Cortex in Functional Movement Disorders
This study is testing if a new type of brain stimulation can help people with functional movement disorders feel better and improve their symptoms.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT05155059 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of intermittent theta burst stimulation (iTBS) targeting the left dorsolateral prefrontal cortex in patients diagnosed with functional movement disorders (FMD). Participants aged 18 to 80 will be randomly assigned to receive either active or sham brain stimulation over five consecutive days. The study will assess changes in motor symptoms using the Functional Movement Disorder Rating Scale, as well as mood symptoms and neuroimaging outcomes. Baseline assessments will include neurological exams, questionnaires, urine tests, and brain MRIs.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 diagnosed with functional movement disorder by a neurologist.
Not a fit: Patients with current psychosis, active suicidal ideation, or significant neurological disorders other than FMD may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve symptoms and quality of life for patients suffering from functional movement disorders.
How similar studies have performed: Other studies using transcranial magnetic stimulation have shown promise in treating various neurological conditions, suggesting potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
* INCLUSION CRITERIA: In order to be eligible to participate in this study, an individual must meet all of the following criteria: * Stated willingness to comply with all study procedures and availability for the duration of the study * Male or female, aged 18-80 * Diagnosis of functional movement disorder made by a neurologist * Agreement to adhere to Lifestyle Considerations throughout study duration * Ability of subject to understand and the willingness to sign a written informed consent document. EXCLUSION CRITERIA: An individual who meets any of the following criteria will be excluded from participation in this study: * Current psychosis or active suicidal ideation * History of epilepsy with the exception of febrile seizure * Patients with psychogenic non-epileptic seizure without comcomitant functional movement disorder * Any significant neurological disorders other than FMD including but not limited to multiple sclerosis, stroke, Parkinson s disease, space occupying brain lesion * Alcohol or substance use disorder * Patients who are on Buproprion (Wellbutrin) * Patients with moderate to severe cardiac disease * Any psychiatric, medical or social condition 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. * Pregnancy
Where this trial is running
Bethesda, Maryland
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Debra J Ehrlich, M.D. — National Institute of Neurological Disorders and Stroke (NINDS)
- Study coordinator: Hyun Joo Cho, M.D.
- Email: hyunjoo.cho@nih.gov
- Phone: Not Listed
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.