Neurophysiologic Study of Patient With Essential Tremor and Dystonic Tremor

NCT03041714 | Completed

• 2 other identifiers: 17005317-N-0053
• Study Type: observational
• Target: 2
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Essential Tremor; Cervical Dystonia; Focal Dystonia

Keywords

Essential Tremor; Cervical Dystonia; Hand Dystonia; Neurophysiology; Dystonic Tremor

Outcome Measures

Primary Outcomes (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.

  2 years

Study Arms (3)

Normal volunteers

people who are healthy and without tremor

Essential tremor

Patients with essential tremor

Dystonic tremor

patient with tremor who also have dystonia

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients will be referred to NIH or may refer themselves from all over the United States.

You may qualify if:

• 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.

You may not qualify if:

• 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 rescheduled.
• Has more than 7 alcoholic drinks a week in the case of a woman and 14 alcoholic drinks a week in the case of a man.
• Abnormal findings on neurologic exam (other than tremor and dystonia in patient group)
• Has had a brain tumor, a stroke, head trauma, epilepsy or a history of seizures.
• Has major depression or any major mental disorders (axis I disorders)
• Has a neurologic disorder other than tremor or dystonia
• Has had a head injury where there was a loss of consciousness for more than a few seconds.
• Currently taking primidone, anticholinergics or benzodiazepines.
• Healthy Volunteers:
• 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 rescheduled.
• Has more than 7 alcoholic drinks a week in the case of a woman and 14 alcoholic drinks a week in the case of a man.

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 Publications (3)

• Deuschl G, Bain P, Brin M. Consensus statement of the Movement Disorder Society on Tremor. Ad Hoc Scientific Committee. Mov Disord. 1998;13 Suppl 3:2-23. doi: 10.1002/mds.870131303.

  PMID: 9827589 BACKGROUND

• Ni Z, Pinto AD, Lang AE, Chen R. Involvement of the cerebellothalamocortical pathway in Parkinson disease. Ann Neurol. 2010 Dec;68(6):816-24. doi: 10.1002/ana.22221.

  PMID: 21194152 BACKGROUND

• Pascual-Leone A, Valls-Sole J, Toro C, Wassermann EM, Hallett M. Resetting of essential tremor and postural tremor in Parkinson's disease with transcranial magnetic stimulation. Muscle Nerve. 1994 Jul;17(7):800-7. doi: 10.1002/mus.880170716.

  PMID: 8008009 BACKGROUND

MeSH Terms

Conditions

Essential Tremor; Torticollis; Dystonic Disorders

Condition Hierarchy (Ancestors)

Movement Disorders; Central Nervous System Diseases; Nervous System Diseases; Dystonia; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mark Hallett, M.D.

  National Institute of Neurological Disorders and Stroke (NINDS)

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 2, 2017
• First Posted: February 3, 2017
• Study Start: April 7, 2017
• Primary Completion: March 22, 2018
• Study Completion: March 22, 2018
• Last Updated: August 1, 2018

Record last verified: 2018-03

Locations

US (1)