Clinical and Physiological Studies of Tremor Syndromes

NCT03027310 | Completed

• 2 other identifiers: 17003517-N-0035
• Study Type: observational
• Target: 85
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Parkinson Disease; Dystonia; Essential Tremor

Keywords

Dystonic Tremor; Essential Tremor; Parkinsonism; Voice Tremor; Parkinson's Disease; Natural History

Outcome Measures

Primary Outcomes (1)

• methods for tremor phenotyping

  clinical rating scales and questionnaires, electrophysiological tremor studies, videotaped exam, as well as digitizing based tasks. EMG, EEG, MEG, TMS, MRI. Behavioral measures such as reaction times to initiate movements, EMG patterns, movement kinematics, eye movement.

  throughout protocol

Study Arms (2)

Healthy Volunteers

adult healthy volunteers

tremor patients

adult patients with tremor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Experimental subjects will include healthy volunteer subjects and patients with tremor syndromes including, but not limited to ET, PD-tremor, and dystonic tremor. The diagnosis will be made by a movement disorders neurologist at the NINDS movement disorders clinics. Healthy volunteers will be recruited for the following purposes: (1) to optimize data acquisition and analysis techniques; and (2) to serve as negative controls for clinical, imaging, and biological variables measured in the patient cohorts. Without data obtained from healthy volunteers, there is no way to determine whether subtle findings in tremor (e.g., physiological tremor) are truly abnormal. The inclusion of healthy volunteers therefore allows to correctly threshold and quantify observed abnormalities. Healthy volunteers may also include non-affected family members of patients with tremor

You may qualify if:

• 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 sub-study visits because both agents can modify brain activity and may confound outcome measures.
• Age 18 or older.
• Able to give informed consent.
• Agree to not consume caffeine or alcohol for 12 hours before selected sub-study visits because both agents may modify the activity of the brain during the study.

You may not qualify if:

• 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.
• 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.
• We will follow the NMR Center guidelines for MR safety.
• 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

Sponsors & Collaborators

• National Institute of Neurological Disorders and Stroke (NINDS): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Parkinson Disease; Dystonia; Essential Tremor; Parkinsonian Disorders

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Debra J Ehrlich, M.D.

  National Institute of Neurological Disorders and Stroke (NINDS)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2017
• First Posted: January 23, 2017
• Study Start: May 5, 2017
• Primary Completion: March 23, 2022
• Study Completion: March 23, 2022
• Last Updated: November 12, 2025

Record last verified: 2025-11-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Starting 6 months after publication.
• Access Criteria: Requests will be considered on a case-by-case basis and we will try to uphold the NIH data-sharing directive. At the same time we may need IRB approval and/or data sharing agreements to be in place before we send data to others.

Locations

US (1)