Clinical and Physiological Studies of Tremor Syndromes (NCT03027310) | Clinical Trial Compass
CompletedNot Applicable
Clinical and Physiological Studies of Tremor Syndromes
United States85 participantsStarted 2017-05-05
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* 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 sub-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 sub-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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
methods for tremor phenotyping
Timeframe: throughout protocol
Trial details
NCT IDNCT03027310
SponsorNational Institute of Neurological Disorders and Stroke (NINDS)