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Protocol Details

Clinical and Physiological Studies of Tremor Syndromes

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

17-N-0035

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: N/A

Referral Letter Required

No

Population Exclusion(s)

Children

Special Instructions

Currently Not Provided

Keywords

Dystonic Tremor;
Essential Tremor;
Tremor;
Voice Tremor;
Parkinson's Disease

Recruitment Keyword(s)

None

Condition(s)

Parkinson Disease;
Dystonia;
Essential Tremor

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Institute of Neurological Disorders and Stroke

Background:

Researchers have some data on how the brain controls movement and why some people have tremor. But the causes of tremor are not fully known. Researchers want to study people with tremor to learn about changes in the brain and possible causes of tremor.

Objective:

To better understand how the brain controls movement, learn more about tremor, and train movement disorder specialists.

Eligibility:

People ages 18 and older with a diagnosed tremor syndrome

Healthy volunteers ages 18 and older

Design:

Participants will be screened with:

-Medical history

-Physical exam

-Urine tests

-Clinical rating scales

-Health questions

-They may have electromyography (EMG) or accelerometry. Sensors or electrodes taped to the skin measure movement.

Participation lasts up to 1 year.

Some participants will have a visit to examine their tremor more. They may have rating scales, EMG, and drawing and writing tests.

Participants will be in 1 or more substudies. These will require up to 7 visits. Visits could include the following:

-EMG with accelerometry

-Small electrodes taped on the body give small electric shocks that stimulate nerves.

-MRI: Participants lie on a table that slides into a cylinder that takes pictures of the body while they do simple tasks.

-Small electrodes on the scalp record brain waves.

-A cone with detectors on the head measures brain activity while participants do tasks.

-A wire coil held on the scalp gives an electrical current that affects brain activity.

-Tests for thinking, memory, smell, hearing, or vision

-Electrodes on the head give a weak electrical current that affects brain activity.

-Photographs or videos of movement

Participant data may be shared with other researchers.

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Eligibility

INCLUSION CRITERIA FOR TREMOR PATIENTS:

-Patients diagnosed with a tremor syndrome, including, but not limited to

--Essential tremor (per definition of the Tremor Research Group)

--Parkinson disease (per UK Brain Bank criteria)

--Focal tremor such as isolated head tremor, voice tremor

--Task-specific tremor such as primary writing tremor

--Orthostatic tremor

--Patients with other tremor syndromes such as dystonic tremor, intention tremor, etc.

-Age 18 or older

-Able to give informed consent

-Agree to not drink caffeine or alcohol for 12 hours before phenotyping and selected thematic study visits because both agents can modify brain activity and may confound outcome measures.

INCLUSION CRITERIA FOR HEALTHY VOLUNTEERS:

-Age 18 or older.

-Able to give informed consent.

-Agree to not consume caffeine or alcohol for 12 hours before selected thematic study visits because both agents may modify the activity of the brain during the study.

EXCLUSION CRITERIA FOR TREMOR PATIENTS:

-Problematic alcohol use, as defined by a score of 8 or higher on the WHO Alcohol Use Disorders Identification Test (AUDIT).

-History of a brain tumor, a stroke, traumatic brain injury, epilepsy or a history of seizures.

-History of psychotic disorder, Bipolar Disorder or a current depressive episode.

-History or clinical evidence of another neurologic disorder than a tremor syndrome as defined above, which may interfere with the ability to comply with protocol requirements or interpret the obtained results.

EXCLUSION CRITERIA FOR HEALTHY VOLUNTEERS:

-Have abnormal findings of clinical significance on the neurological examination that may affect the scientific integrity of the study

-Problematic alcohol use, as defined by a score of 8 or higher on the WHO Alcohol Use Disorders Identification Test (AUDIT)

-History of a brain tumor, a stroke, traumatic brain injury, epilepsy or a history of seizures.

-History of psychotic disorder, Bipolar Disorder or a current depressive episode.

ADDITIONAL EXCLUSION CRITERIA FOR MOVEMENT DISORDER PATIENTS AND HEALTHY VOLUNTEERS SPECIFICALLY FOR 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.

-Have uncontrolled movements of the head.

-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.

-Non-removable body piercing or tattoo posing MRI risk

-Pregnancy.

ADDITIONAL EXCLUSION CRITERIA FOR TREMOR PATIENTS AND HEALTHY VOLUNTEERS FOR TMS AND MRI:

-Ferromagnetic metal in the cranial cavity or eye, e.g. aneurysm clip or ocular foreign body.

-Implanted electronic device including deep brain stimulation systems.


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Debra J. Ehrlich, 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:

NCT03027310

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