NCT00310414

Brief Summary

This study will examine how the brain makes involuntary spasms and contractions in patients with focal hand dystonia (FHD). Patients with dystonia have muscle spasms that cause uncontrolled twisting and repetitive movement or abnormal postures. In FHD, only the hand is involved. The study will use functional magnetic resonance imaging (fMRI, see below) to study which areas of the brain are primarily affected in FHD and better understand how brain changes produce dystonia symptoms. Normal right-handed volunteers and patients with FHD who are 18-65 years of age may be eligible for this study. Candidates are screened with a medical history and physical and neurological examinations. Women who can become pregnant have a urine pregnancy test. All participants undergo fMRI. This test uses a strong magnetic field and radio waves to obtain images of body organs and tissues. The subject 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 is asked to lie still for 10-15 minutes at a time. During the procedure, subjects are asked to perform some tasks, including writing, tapping with their hand, and drawing in a zigzag motion. Each task is performed using the right hand, left hand and right foot.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
51

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2006

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

March 30, 2006

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

March 31, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 3, 2006

Completed
5.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 13, 2012

Completed
Last Updated

July 2, 2017

Status Verified

March 13, 2012

First QC Date

March 31, 2006

Last Update Submit

June 30, 2017

Conditions

Keywords

Imaging StudiesBotulinum ToxinWriter's CrampFocal Hand DystoniaFHDWriter CrampHealthy VolunteerHV

Eligibility Criteria

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

You may qualify if:

  • Focal Dystonia Subjects must be:
  • Right hand dominant
  • Between 18 and 65 years old
  • Diagnosed with mild, simple focal hand dystonia. For this study mild, simple focal hand dystonia suggests that the patient does not present symptoms when performing tasks other than writing. Additionally, the patient should be able to write for 20 seconds consecutively
  • Willing to abstain from alcohol 48 hours prior to the study
  • Volunteers must be:
  • Healthy right-handed dominant individuals
  • Between 18 and 65 years old
  • Willing to abstain from alcohol 48 hours prior to the study

You may not qualify if:

  • 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
  • Subjects with any finding on the MRI safety questionnaire which prevents them from safely undergoing an MRI scan
  • Subjects who are pregnant.
  • Subjects with claustrophobia or other restrictions which prevent them from undergoing a scan in a confined space for up to 60 minutes
  • Subjects with any visual, motor, or hearing difficulties
  • Subjects with severe focal hand dystonia i.e., subjects who experience dystonic spasms in tasks other than/in addition to writing
  • Subjects with mirror dystonia
  • Subjects without the capacity to give consent
  • Subjects with any history of a severe medical condition, such as cardiovascular disease, which will prevent them from lying flat for up to 60 minutes.
  • Subjects with any history of brain tumor, stroke, head trauma or vascular malformation as obtained by history or from imaging studies.
  • Subjects who have had recent (within 3 months) Botulinum Toxin (Botox) injections.
  • Subjects who are on anti-parkinsonian drugs

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
  • Butterworth S, Francis S, Kelly E, McGlone F, Bowtell R, Sawle GV. Abnormal cortical sensory activation in dystonia: an fMRI study. Mov Disord. 2003 Jun;18(6):673-82. doi: 10.1002/mds.10416.

    PMID: 12784271BACKGROUND
  • Blood AJ, Flaherty AW, Choi JK, Hochberg FH, Greve DN, Bonmassar G, Rosen BR, Jenkins BG. Basal ganglia activity remains elevated after movement in focal hand dystonia. Ann Neurol. 2004 May;55(5):744-8. doi: 10.1002/ana.20108.

    PMID: 15122718BACKGROUND

MeSH Terms

Conditions

Dystonic DisordersDystonia, Focal, Task-Specific

Condition Hierarchy (Ancestors)

Movement DisordersCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Kenneth H Fischbeck, M.D.

    National Institute of Neurological Disorders and Stroke (NINDS)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

March 31, 2006

First Posted

April 3, 2006

Study Start

March 30, 2006

Study Completion

March 13, 2012

Last Updated

July 2, 2017

Record last verified: 2012-03-13

Locations