Neurophysiologic Study of Patient With Essential Tremor and Dystonic Tremor
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03041714|
Recruitment Status : Recruiting
First Posted : February 3, 2017
Last Update Posted : February 14, 2018
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.
To look at differences between essential tremor and dystonic tremor.
People ages 18 and older with or without tremor
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.
|Condition or disease|
|Essential Tremor Cervical Dystonia Focal Dystonia|
To explore a neurophysiological difference between patients with essential tremor (ET) and dystonic tremor (DT).
Sample Size and Population:
We plan to recruit 26 healthy volunteers (HVs), 26 patients with ET, 26 patients with dystonic tremor from the Movement Disorders and Botulinum Toxin (BoNT) clinics of HMCS. The dystonic tremor group will be divided into 2 subgroups: pure dystonic tremor (pDT), patients who have dystonia and tremor in the same limb, tremor associated with dystonia (TAWD), patients who have isolated tremor with dystonia elsewhere. We plan to enroll 13 patients with pDT and 13 with TAWD. We plan to recruit a total of 20 participants including patients with ET, DT and HVs if the use of data from protocol 10-N-0009 is permitted. All neurophysiologic results will be compared between patients and HVs.
Subjects will come to NIH for at least one study visit. All subjects will undergo a screening visit including taking a medical history and physical examination. Then the patients will be scored clinically for tremor in both ET and DT and dystonia only for DT. All subjects will have a series of transcranial magnetic stimulation (TMS) studies. TMS-induced electromyographic (EMG) activity of hand and forearm muscles will be recorded as motor evoked potentials (MEPs). Pyramidal threshold will be determined by inion stimulation. Then, paired-pulse stimulation at the cerebellum followed by the motor cortex will be performed at rest and at tonic activation of the hand muscle. Only patients will have recordings of tremor at rest, postural holding, and with action and specific tasks such as writing by using accelerometry and EMG. Additionally, a single TMS will be delivered to the motor cortex or cerebellum while the patients elicit their tremor in order to explore the effect of TMS on tremor. All subjects (both HVs and ET, DT) will be tested for their threshold to discriminate somatosensory stimulation and for their performance of quick ballistic movements. All subjects will also undergo a magnetic resonance imaging (MRI) study which includes structural MRI, resting state functional MRI (rsfMRI), diffusion tensor imaging (DTI), MR spectroscopy. The subjects can either undergo the MRI study on the same visit as the other parts of experiment or do it separately.
The various neurophysiological results include the data from the TMS experiment, tremor analysis, threshold of temporal discrimination, ballistic movement and MRI experiment. These results will be compared between HVs and patients group.
|Study Type :||Observational|
|Estimated Enrollment :||78 participants|
|Official Title:||Neurophysiologic Study of Patients With Essential Tremor and Dystonic Tremor|
|Actual Study Start Date :||April 7, 2017|
|Estimated Primary Completion Date :||October 31, 2019|
|Estimated Study Completion Date :||October 31, 2019|
people who are healthy and without tremor
Patients with essential tremor
patient with tremor who also have dystonia
- 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. [ Time Frame: 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03041714
|Contact: Elaine P Considine, R.N.||(301) firstname.lastname@example.org|
|United States, Maryland|
|National Institutes of Health Clinical Center||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL) 800-411-1222 ext TTY8664111010 email@example.com|
|Principal Investigator:||Mark Hallett, M.D.||National Institute of Neurological Disorders and Stroke (NINDS)|