NCT00137384

Brief Summary

This study will use various methods to measure the activity of the motor cortex (the part of the brain that controls movements) in order to learn more about focal hand dystonia. Patients with dystonia have muscle spasms that cause uncontrolled twisting and repetitive movement or abnormal postures. In focal dystonia, just one part of the body, such as the hand, neck or face, is involved. Patients with focal hand dystonia and healthy normal volunteers between 18 and 65 years of age may be eligible for this study. Each candidate is screened with a medical history, physical examination and questionnaire. Participants undergo the following procedures: Finger Movement Tasks Subjects perform two finger movement tasks. In the first part of the study, they move their index finger repetitively from side to side at 10-second intervals for a total of 200 movements in four blocks of 50 at a time. In the second part of the study, subjects touch their thumb to the other four fingers in sequence from 1, 2, 3 and 4, while a metronome beats 2 times per second to help time the movements. This sequence is repeated for a total of 200 movements in four blocks of 50 at a time. Electroencephalography This test records brain waves. Electrodes (metal discs) are placed on the scalp with an electrode cap, a paste or a glue-like substance. The spaces between the electrodes and the scalp are filled with a gel that conducts electrical activity. Brain waves are recorded while the subject performs a finger movement task, as described above. Magnetoencephalography MEG records magnetic field changes produced by brain activity. During the test, the subjects are seated in the MEG recording room and a cone containing magnetic field detectors is lowered onto their head. The recording may be made while the subject performs a finger task. Electromyography Electromyography (EMG) measures the electrical activity of muscles. This study uses surface EMG, in which small metal disks filled with a conductive gel are taped to the skin on the finger. Magnetic resonance imaging MRI uses a magnetic field and radio waves to produce images of body tissues and organs. The patient lies on a table that can slide in and out of the scanner (a narrow metal cylinder), wearing earplugs to muffle loud knocking and thumping sounds that occur during the scanning. Most scans last between 45 and 90 minutes. Subjects may be asked to lie still for up to 30 minutes at a time, and can communicate with the MRI staff at all times during the procedure. Questionnaire This questionnaire is designed to detect any sources of discomfort the subject may have experienced during the study.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2005

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 25, 2005

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

August 26, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 29, 2005

Completed
12.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 27, 2018

Completed
Last Updated

May 1, 2018

Status Verified

April 27, 2018

First QC Date

August 26, 2005

Last Update Submit

April 28, 2018

Conditions

Keywords

MagnetoencephalogramFunctional ConnectivityElectroencephalogram (EEG)Focal Hand DystoniaSpectral AnalysisHealthy VolunteerHV

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Normal subjects: Healthy volunteers ages 18 and older who consent to participate in the study
  • Patients ages 18 and older diagnosed with focal hand dystonia unilateral focal hand dystonia who consent to participate in the study

You may not qualify if:

  • Normal subjects: abnormal neurologic exam or history of previous neurological disease that might affect the functioning of the hands
  • Dystonia patients: presence of a second neurologic disease or condition that might affect the functioning of the hands; abnormal neurologic findings on exam not related to the focal hand dystonia that might affect the functioning of the hands; the use of Botulinum toxin within 3 months prior to study participation
  • For MRI studies, patients with metallic implants will be excluded to avoid potential risks from this procedure
  • For MRI studies, women who are pregnant are excluded from this part of the protocol. All women of childbearing potential will have a pregnancy test performed prior to MRI studies, which must be negative, before proceeding.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • Abbruzzese G, Berardelli A. Sensorimotor integration in movement disorders. Mov Disord. 2003 Mar;18(3):231-240. doi: 10.1002/mds.10327.

    PMID: 12621626BACKGROUND
  • Abbruzzese G, Marchese R, Buccolieri A, Gasparetto B, Trompetto C. Abnormalities of sensorimotor integration in focal dystonia: a transcranial magnetic stimulation study. Brain. 2001 Mar;124(Pt 3):537-45. doi: 10.1093/brain/124.3.537.

    PMID: 11222454BACKGROUND
  • Andres FG, Gerloff C. Coherence of sequential movements and motor learning. J Clin Neurophysiol. 1999 Nov;16(6):520-7. doi: 10.1097/00004691-199911000-00004.

    PMID: 10600020BACKGROUND

MeSH Terms

Conditions

Movement DisordersDystonic DisordersDystonia, Focal, Task-Specific

Condition Hierarchy (Ancestors)

Central Nervous System DiseasesNervous System Diseases

Study Officials

  • Mark Hallett, M.D.

    National Institute of Neurological Disorders and Stroke (NINDS)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 26, 2005

First Posted

August 29, 2005

Study Start

August 25, 2005

Study Completion

April 27, 2018

Last Updated

May 1, 2018

Record last verified: 2018-04-27

Locations