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Protocol Details

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

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

17-N-0160

Sponsoring Institute

National Institute of Neurological Disorders and Stroke (NINDS)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18
Max Age: 65

Referral Letter Required

No

Population Exclusion(s)

Children

Special Instructions

Currently Not Provided

Keywords

Functional (BOLD) MRI

Recruitment Keyword(s)

None

Condition(s)

Movement Disorders

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Institute of Neurological Disorders and Stroke

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

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Eligibility

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)


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Citations:

Stone J, Carson A, Duncan R, Roberts R, Coleman R, Warlow C, Murray G, Pelosi A, Cavanagh J, Matthews K, Goldbeck R, Sharpe M. Which neurological diseases are most likely to be associated with "symptoms unexplained by organic disease". J Neurol. 2012 Jan;259(1):33-8. doi: 10.1007/s00415-011-6111-0. Epub 2011 Jun 16.

Carson A, Stone J, Hibberd C, Murray G, Duncan R, Coleman R, Warlow C, Roberts R, Pelosi A, Cavanagh J, Matthews K, Goldbeck R, Hansen C, Sharpe M. Disability, distress and unemployment in neurology outpatients with symptoms 'unexplained by organic disease'. J Neurol Neurosurg Psychiatry. 2011 Jul;82(7):810-3. doi: 10.1136/jnnp.2010.220640. Epub 2011 Jan 21.

Gelauff J, Stone J, Edwards M, Carson A. The prognosis of functional (psychogenic) motor symptoms: a systematic review. J Neurol Neurosurg Psychiatry. 2014 Feb;85(2):220-6. doi: 10.1136/jnnp-2013-305321. Epub 2013 Sep 12.

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Contacts:

Principal Investigator

Referral Contact

For more information:

Mark Hallett, M.D.
National Institute of Neurological Disorders and Stroke (NINDS)



Elaine P. Considine, R.N.
National Institute of Neurological Disorders and Stroke (NINDS)
National Institutes of Health
Building 10
Room 7D36
10 Center Drive
Bethesda, Maryland 20892
(301) 435-8518
considinee@ninds.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: 1-866-411-1010
PRPL@cc.nih.gov

Clinical Trials Number:

NCT03263013

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