NCT00025701

Brief Summary

This study will examine how the brain operates during execution and control of voluntary movement and what goes wrong with these processes in disease. It will use electroencephalography (EEG) and electromyography (EMG) to compare brain function in normal subjects and in patients with focal hand dystonia. In dystonia, involuntary muscle movements, or spasms, cause uncontrolled twisting and repetitive movement or abnormal postures. Focal dystonia involves just one region of the body, such as the hand, neck or face. EEG measures the electrical activity of the brain. The activity is recorded using wire electrodes attached to the scalp or mounted on a Lycra cap placed on the head. EMG measures electrical activity from muscles. It uses wire electrodes placed on the skin over the muscles. Adult healthy normal volunteers and patients with focal hand dystonia may be eligible for this study. Patients will be selected from NINDS's dystonia patient database. Participants will sit in a semi-reclining chair in a darkened room and be asked to move either their right index finger, right foot, or the angle of their mouth on the right side at a rate of one movement every 10 seconds. Brain and muscle activity will be measured during this task with EEG and EMG recordings.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2001

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 9, 2001

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

October 11, 2001

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 12, 2001

Completed
9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 4, 2010

Completed
Last Updated

July 2, 2017

Status Verified

October 4, 2010

First QC Date

October 11, 2001

Last Update Submit

June 30, 2017

Conditions

Keywords

CortexInhibitionMotor ControlEvent-Related SynchronizationEvent-Related DesynchronizationFocal Hand DystoniaFocal DystoniaDystoniaHandHealthy VolunteerHV

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The study population will consist of (a) healthy volunteers; and (b) patients with focal hand dystonia.
  • Healthy subjects: Healthy volunteers who consented to participate in the study.
  • Patients diagnosed with focal hand dystonia: unilateral focal hand dystonia from our dystonia patient database who consented to participate in the study.

You may not qualify if:

  • Healthy subjects: abnormal neurological exam or history of past neurological disease.
  • Dystonia patients: the presence of a second neurological disease or condition; abnormal neurological findings on exam that are not related to their focal hand dystonia.
  • For MRI studies, patients with metallic implants will be excluded to remove potential risks from this procedure.
  • For MRI purposes, women who are pregnant are excluded from this part of the protocol. Therefore, all women of childbearing potential will have a pregnancy test performed prior to prospective MRI studies, which must be negative, before proceeding.
  • For TMS studies, healthy volunteers or focal hand dystonia patients who have a pacemaker, an implanted medical pump, a metal plate or metal object in the skull or eye (for example, after brain surgery), or who have a history of seizure disorder will be excluded from the trial.

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)

  • Bara-Jimenez W, Catalan MJ, Hallett M, Gerloff C. Abnormal somatosensory homunculus in dystonia of the hand. Ann Neurol. 1998 Nov;44(5):828-31. doi: 10.1002/ana.410440520.

    PMID: 9818942BACKGROUND
  • Allard T, Clark SA, Jenkins WM, Merzenich MM. Reorganization of somatosensory area 3b representations in adult owl monkeys after digital syndactyly. J Neurophysiol. 1991 Sep;66(3):1048-58. doi: 10.1152/jn.1991.66.3.1048.

    PMID: 1753275BACKGROUND
  • 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

MeSH Terms

Conditions

Dystonic DisordersInhibition, PsychologicalDystonia, Focal, Task-SpecificDystonia

Condition Hierarchy (Ancestors)

Movement DisordersCentral Nervous System DiseasesNervous System DiseasesBehaviorDyskinesiasNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

October 11, 2001

First Posted

October 12, 2001

Study Start

October 9, 2001

Study Completion

October 4, 2010

Last Updated

July 2, 2017

Record last verified: 2010-10-04

Locations