Neurophysiologic Study of Patient With Essential Tremor and Dystonic Tremor (NCT03041714) | Clinical Trial Compass
CompletedNot Applicable
Neurophysiologic Study of Patient With Essential Tremor and Dystonic Tremor
United States2 participantsStarted 2017-04-07
Plain-language summary
Background:
Essential tremor is when a person has tremor, but no other neurological symptoms. Dystonic tremor is when a person also has dystonia. Dystonia is a condition in which muscle contraction causes changes in posture. Researchers do not fully know what areas of the brain cause these tremors, or how the types differ. They also do not know what tests can identify the differences.
Objective:
To look at differences between essential tremor and dystonic tremor.
Eligibility:
People ages 18 and older with or without tremor
Design:
Participants will be screened with medical history, physical exam, and urine tests. Those with tremor will complete questionnaires about how tremor affects them.
The screening and study visits can be done on the same day or on separate days.
Participants will have 1 or 2 study visits. These include magnetic resonance imaging (MRI) and tremor testing.
For MRI, participants will lie on a table that slides in and out of a cylinder that takes pictures. Sensors on the skin measure breathing, heart rate, and muscle activity. This takes about 2 hours.
Tremor testing will include transcranial magnetic stimulation (TMS), electrical stimulation of the fingers, doing a movement task, and recording of tremor movements. For TMS, two wire coils will be held on the scalp and a brief magnetic field will be produced. A brief electrical current will pass through the coils. For the other tests, small sticky pad electrodes will be put on the skin. Participants will move their hand when they hear a sound. They will get weak electrical shocks to their fingers. These tests will take 3-4 hours.
Participants can take part in either or both parts of the study.
Who can participate
Age range
18 Years – 85 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
Tremor Subjects:
* Must be 18 years or older
* Fulfill the diagnostic criteria of essential tremor, pure dystonic tremor and tremor associated dystonia, as defined by the Consensus Statement of the Movement Disorder Society on Tremor, 1998. We will recruit patients displaying hand tremors in each group as the follows:
* Hand tremor patients in ET group.
* Dystonic hand tremor patients in pDT group.
* Cervical dystonia (CD) patients or spasmodic dysphonia and hand tremor without clinical evidence of hand dystonia in TAWD group.
* Ability to give informed consent.
* Ability to comply with all study procedures, based on the judgment by the investigator(s).
* Agree to not drink caffeine or alcohol for 48 hours before participating in the protocol.
Healthy Volunteers:
* Must be 18 years or older
* Absence of dystonia or other neurological disorder with any effect on the motor or sensory systems.
* Ability to give informed consent.
* Ability to comply with all study procedures, based on the judgment by the investigator(s).
* Agree to not drink caffeine or alcohol for 48 hours before participating in the protocol.
EXCLUSION CRITERIA:
Patients:
* Botulinum toxin treatment \< 3 months prior to visit.
* Employees and/or staff of NINDS
* Has used illegal drugs within the past 6 months based on history. The intent is to exclude those with drug use that may affect study results. Participants who appear to be intoxicated at the time of testing will be res…
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
The various neurophysiological results including the data from TMS experiment, tremor analysis, threshold of temporal discrimination, ballistic movement and MRI experiment. These results will be compared between HVs and patients group.
Timeframe: 2 years
Trial details
NCT IDNCT03041714
SponsorNational Institute of Neurological Disorders and Stroke (NINDS)