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Protocol Details

Phase II Trial of Non-Invasive Intermittent Theta Burst Stimulation of the Dorsolateral Prefrontal Cortex in Functional Movement Disorders

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

000642-N

Sponsoring Institute

National Institute of Neurological Disorders and Stroke (NINDS)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18 Years
Max Age: 80 Years

Referral Letter Required

No

Population Exclusion(s)

Pregnant Women

Keywords

Functional Movement Disorders;
Transcranial Magnetic Stimulation (TMS);
iTBS;
Repetitive Transcranial Magnetic Stimulation;
Neuroimaging;
Conversion Disorder

Recruitment Keyword(s)

None

Condition(s)

Functional Movement Disorder

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

Device: MagStim
Other: Sham Comparator

Supporting Site

National Institute of Neurological Disorders and Stroke

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.

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Eligibility

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


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Citations:

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Contacts:

Principal Investigator

Referral Contact

For more information:

Hyun Joo Cho, M.D.
National Institute of Neurological Disorders and Stroke (NINDS)
BG 6001 EXECUTIVE BLVD NSC RM 2216
6001 EXECUTIVE BLVD
ROCKVILLE MD 20852
(301) 402-9336
hyunjoo.cho@nih.gov

Hyun Joo Cho, M.D.
National Institute of Neurological Disorders and Stroke (NINDS)
BG 6001 EXECUTIVE BLVD NSC RM 2216
6001 EXECUTIVE BLVD
ROCKVILLE MD 20852
(301) 402-9336
hyunjoo.cho@nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1
ccopr@nih.gov

Clinical Trials Number:

NCT05155059

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