NCT00309010

Brief Summary

This study will examine how the brain coordinates movement in patients with 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. This study will use transcranial magnetic stimulation (TMS, see below) to study how the brain plans movement. Healthy volunteers and patients with focal hand dystonia 18 years of age and older may be eligible for this study. Healthy subjects may participate in one, two or three of the experiments described below. Patients with dystonia may participate in experiments one and three. Before each experiment, each subject is asked about his/her medical and neurologic history, complete questionnaires and will undergo a brief physical examination. Experiment 1

  • Surface EMG: Small electrodes are taped to the skin over the arm to measure the electrical activity of muscles.
  • TMS: A wire coil is held on the subject's scalp. A brief electrical current is passed through the coil, creating a magnetic pulse that stimulates the brain. During the stimulation, the subject may be asked to tense certain muscles slightly or perform other simple actions. The stimulation may cause a twitch in muscles of the face, arm, or leg, and the subject may hear a click and feel a pulling sensation on the skin under the coil. Experiment 2 (Two visits.)
  • Visit 1: Magnetic resonance imaging (MRI): This test uses a magnetic field and radio waves to obtain images of body tissues and organs. The patient lies on a table that is moved into the scanner (a metal cylinder), wearing earplugs to muffle loud knocking and thumping sounds that occur during the scanning process. The procedure lasts about 90 minutes, during which time the patient will be asked to lie still for up to 30 minutes at a time.
  • Visit 2: Surface EMG and TMS Experiment 3
  • Surface EMG and TMS - During the TMS, subjects are asked to respond to shapes on a computer screen by pushing a button or pressing a foot petal.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
115

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2006

Typical duration 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

March 28, 2006

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

March 29, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 30, 2006

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 24, 2009

Completed
Last Updated

July 2, 2017

Status Verified

February 24, 2009

First QC Date

March 29, 2006

Last Update Submit

June 30, 2017

Conditions

Keywords

Focal Hand DystoniaMotor PlanningTranscranial Magnetic Stimulation (TMS)MRI (Magnetic Resonance Imaging)FHDWriter's CrampHealthy VolunteerHV

Eligibility Criteria

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

You may qualify if:

  • Patients:
  • Age over 18 years
  • Presence of FHD, specifically writer's cramp
  • Healthy volunteers:
  • Age over 18 years
  • Absence of dystonia or other neurologic condition

You may not qualify if:

  • Patients and Healthy volunteers:
  • Concurrent medical, surgical, neurologic or psychiatric condition
  • Taking medications which include antidepressants, anxiolytics, anticonvulsants, antipsychotics, antiparkinson, hypnotics, stimulants, and/or antihistamines
  • Received botulinum toxin injection within 3 months of starting the protocol
  • Presence of pacemaker, implanted medical pump, metal plate or metal object in skull or eye
  • History of seizure disorder
  • For healthy volunteers undergoing MRI, subjects with implanted devices such as pacemakers, medication pumps or defibrillators, metal in the cranium except mouth, intracardiac lines, history of shrapnel injury or any other condition/device that may be contraindicated or prevent the acquisition of MRI and/or current pregnancy
  • A serious medical illness which prevents them from lying flat for up to 60 minutes
  • Claustrophobia (a fear of tight spaces), which prevents them from lying still in a tight or small space for up to 60 minutes

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)

  • Hallett M. Dystonia: abnormal movements result from loss of inhibition. Adv Neurol. 2004;94:1-9. No abstract available.

    PMID: 14509648BACKGROUND
  • Bressman SB. Dystonia genotypes, phenotypes, and classification. Adv Neurol. 2004;94:101-7. No abstract available.

    PMID: 14509661BACKGROUND
  • Chen R, Hallett M. Focal dystonia and repetitive motion disorders. Clin Orthop Relat Res. 1998 Jun;(351):102-6.

    PMID: 9646753BACKGROUND

MeSH Terms

Conditions

Dystonic DisordersDystonia, Focal, Task-Specific

Condition Hierarchy (Ancestors)

Movement DisordersCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

March 29, 2006

First Posted

March 30, 2006

Study Start

March 28, 2006

Study Completion

February 24, 2009

Last Updated

July 2, 2017

Record last verified: 2009-02-24

Locations