NCT00031369

Brief Summary

This study will use high-resolution magnetic resonance imaging (MRI) to look for subtle differences in brain anatomy between patients with focal hand dystonia (also called writer s cramp) and healthy normal volunteers. Patients with hand dystonia have prolonged muscle contractions that cause sustained twisting movements and abnormal postures. These abnormal movements often occur with activities such as writing, typing, playing certain musical instruments such as guitar or piano, or playing golf or darts. Patients with focal hand dystonia and healthy volunteers will be enrolled in this study. Patients will be recruited from NINDS s database of patients with focal hand dystonia. Volunteers will be selected to match the patients in age, sex and handedness. This study involves two visits to the NIH Clinical Center. The first visit is a screening visit, in which patients and volunteers will have a medical history, physical examination, neurological examination, and assessment of handedness. Women of childbearing age will be screened with a pregnancy test. Pregnant women are exclude from this study. Those who join the study will return for a second visit for magnetic resonance imaging. MRI uses a magnetic field and radio waves to produce images of the brain. For the procedure, the participant lies still on a stretcher that is moved into the scanner (a narrow cylinder containing the magnet). Earplugs are worn to muffle loud noises caused by electrical switching of radio frequency circuits used in the scanning process. The scan will last about 45 to 60 minutes, at most. Some volunteers may be asked to return for a third visit to obtain a second MRI on a different scanner.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
189

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2002

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

February 27, 2002

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

March 2, 2002

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 4, 2002

Completed
13 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2015

Completed
Last Updated

October 6, 2017

Status Verified

March 10, 2015

First QC Date

March 2, 2002

Last Update Submit

October 5, 2017

Conditions

Keywords

MRIWriter's CrampMovement DisorderGray MatterBrain MorphologyDystoniaFocal Hand DystoniaHealthy VolunteerHVNormal Control

Eligibility Criteria

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

You may qualify if:

  • HEALTHY VOLUNTEERS: Healthy volunteers who consented to participate in the study and matched for age, sex, handedness with the group of patients with primary focal hand dystonia.
  • PATIENTS: Patient with primary focal dystonia from our dystonia patient database who consented to participate in the study. This criterion will be established by the preliminary screening in the Human Motor Control Outpatient Clinic.

You may not qualify if:

  • The following subjects will be excluded:
  • Healthy volunteers with cognitive complaints, abnormal neurological exam or history of past neurological disease.
  • Dystonia patients with the presence of a second neurological disease or condition; abnormal neurological findings on exam that are not related to primary focal dystonia.
  • Subjects with past or present neuropsychiatric illness, head trauma with loss of consciousness, epilepsy, cerebro-vascular disease, migraine, past and present history of alcohol abuse, medical conditions that may alter cerebral structure.
  • Subjects with abnormal MRI findings at visual inspection (prominent normal variants such as mega cisterna or cavum septum pellucidum, signs of severe cortical or subcortical atrophy, brain tumors, vascular diseases, trauma or AVMs).
  • Subjects with any metallic objects within them just prior to MR imaging (cardiac or neural pacemaker, aneurysm clips \[metal clips on the wall of a large artery\], metallic prostheses \[including heart valves and cochlear implants\] or shrapnel fragments. Welders and metal workers are also at risk for injury and may not take part in the study because of possible small metal fragments in the eye of which they may be unaware.
  • Subjects not capable of giving an informed consent.
  • Women who are pregnant
  • Children

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)

  • Berardelli A, Rothwell JC, Hallett M, Thompson PD, Manfredi M, Marsden CD. The pathophysiology of primary dystonia. Brain. 1998 Jul;121 ( Pt 7):1195-212. doi: 10.1093/brain/121.7.1195.

    PMID: 9679773BACKGROUND
  • Bhatia KP, Marsden CD. The behavioural and motor consequences of focal lesions of the basal ganglia in man. Brain. 1994 Aug;117 ( Pt 4):859-76. doi: 10.1093/brain/117.4.859.

    PMID: 7922471BACKGROUND
  • Lee MS, Marsden CD. Movement disorders following lesions of the thalamus or subthalamic region. Mov Disord. 1994 Sep;9(5):493-507. doi: 10.1002/mds.870090502.

    PMID: 7990845BACKGROUND

MeSH Terms

Conditions

DystoniaDystonic DisordersMovement DisordersDystonia, Focal, Task-Specific

Condition Hierarchy (Ancestors)

DyskinesiasNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsCentral Nervous System Diseases

Study Officials

  • Mark Hallett, M.D.

    National Institute of Neurological Disorders and Stroke (NINDS)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2002

First Posted

March 4, 2002

Study Start

February 27, 2002

Study Completion

March 10, 2015

Last Updated

October 6, 2017

Record last verified: 2015-03-10

Locations