NCT00006336

Brief Summary

This study will examine the effectiveness of Braille reading as a sensory training program for improving symptoms of focal (localized) dystonia, a movement disorder caused by sustained muscle contractions. Musicians, writers, typists, athletes and others whose work involves frequent repetitive movements may develop focal dystonia of the hand. Dystonia patients have an impaired sense of touch, and it is thought that symptoms may improve with sensory tactile (touch) training. Patients with task-specific dystonia and healthy normal volunteers may be eligible for this 8-week study. Patients will undergo evaluation of their dystonia and a complete neurologic examination. Healthy volunteers will have a complete physical examination. On the first day of the study, after 4 weeks and after 8 weeks, all participants will have a gap detection test for sensory perception testing. The test uses eight plastic devices called JVP-Domes with ridges of different widths on the surface. The subject's arm and hand are held in palm-up position and the right index finger is tested for about 1 second 20 times with each dome. The subject is asked to report whether the direction of the dome is vertical or horizontal. The test takes about 30 minutes. Patients with dystonia will also have a their symptoms evaluated at these visits. The evaluation involves completing a written questionnaire and writing a paragraph. All participants will be trained in Braille reading at NIH. Sessions will be given every day the first week, twice a week the second and third weeks, and once a week the following weeks.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2000

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

September 1, 2000

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 4, 2000

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 5, 2000

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2001

Completed
Last Updated

March 4, 2008

Status Verified

November 1, 2001

First QC Date

October 4, 2000

Last Update Submit

March 3, 2008

Conditions

Keywords

Gap Detection TestFahn-ScaleVisual Analog and Verbal ScaleWriting Standard ParagraphBraille Reading Grade I

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Patients with idiopathic task specific dystonia and healthy normal volunteers. Patients must not be receiving botulinum-toxin treatment or other medications for the past three months prior to entering the study. Patients must be able to keep their hand in a pronated 'reading' position for one hour.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

National Institute of Neurological Disorders and Stroke (NINDS)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • Byl N, Wilson F, Merzenich M, Melnick M, Scott P, Oakes A, McKenzie A. Sensory dysfunction associated with repetitive strain injuries of tendinitis and focal hand dystonia: a comparative study. J Orthop Sports Phys Ther. 1996 Apr;23(4):234-44. doi: 10.2519/jospt.1996.23.4.234.

    PMID: 8775368BACKGROUND
  • Bara-Jimenez W, Shelton P, Sanger TD, Hallett M. Sensory discrimination capabilities in patients with focal hand dystonia. Ann Neurol. 2000 Mar;47(3):377-80.

    PMID: 10716260BACKGROUND
  • 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

MeSH Terms

Conditions

Dystonic Disorders

Condition Hierarchy (Ancestors)

Movement DisordersCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

October 4, 2000

First Posted

October 5, 2000

Study Start

September 1, 2000

Study Completion

November 1, 2001

Last Updated

March 4, 2008

Record last verified: 2001-11

Locations