NCT00021853

Brief Summary

This study will evaluate the effect of motor training on focal hand dystonia in people with writer's cramp and will examine whether this training affects excitability of the motor cortex of the brain. In dystonia, muscle spasms cause uncontrolled twisting and repetitive movement or abnormal postures. Focal dystonia involves just one part of the body, such as the hand, neck or face. Patients with focal hand dystonia have difficulty with individualized finger movements, which may be due to increased excitability of the motor cortex. Patients with hand dystonia 21 years of age or older may be eligible for this 2-month study. Those taking botulinum toxin injections must stop medication 3 months before entering the study. Participants will undergo a complete neurologic examination. They will undergo motor training with "constraint-induced movement therapy." This therapy involves constraining some fingers while allowing others to move. Participants will have the following tests and procedures at baseline (before motor training), after 4 weeks of motor training, and again after 8 weeks:

  • Handwriting analysis - A computerized program evaluates the degree of "automatic movements" the patient uses in writing, as well as writing pressure and speed.
  • Symptoms evaluation - Patients fill out a written questionnaire about symptoms and rate their improvement, if any, after training.
  • Transcranial magnetic stimulation - The patient is seated in a comfortable chair, and an insulated wire coil is placed on the scalp. Brief electrical currents pass through the coil, creating magnetic pulses that travel to the brain. These pulses generate very small electrical currents in the brain cortex, briefly disrupting the function of the brain cells in the stimulated area. The stimulation may cause muscle twitching or tingling in the scalp, face, arm or hand. During the stimulation, the patient is asked to slightly tense certain muscles in the hand or arm or perform simple actions. Electrodes are taped to the skin over the muscles activated by the stimulation, and the electrical activity in the muscles will be recorded with a computer.
  • Electroencephalogram (EEG) - Wire electrodes are taped to the scalp or placed on a Lycra cap the patient wears to record the brain's electrical activity. Participants will have 50-minute motor training sessions 3 times during the first week of the study, twice the second week and once each in weeks 3 and 4. In addition, they will be required to practice the training at home for 25 minutes each day during week 1 and 50 minutes each day for the remaining 3 weeks. Fingers not being trained will be splinted.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Aug 2001

Shorter than P25 for phase_2

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2001

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

August 8, 2001

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 9, 2001

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2002

Completed
Last Updated

March 4, 2008

Status Verified

August 1, 2002

First QC Date

August 8, 2001

Last Update Submit

March 3, 2008

Conditions

Keywords

IndividualizedFingerTrainingSplintingTMSDystoniaFocal DystoniaMovement DisorderFocal Hand DystoniaWriter's Cramp

Interventions

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Subjects must be 21 years of age or older. Each patient entered into the study must be free of serious somatic disease as determined by a standard physical and neurological examination. Patients receiving botulinum-toxin treatment or other medications for the past three months prior to entering the study are not eligible. Patients who have a pacemaker, an implanted medication pump, a metal plate in the skull, metal objects inside the eye or skull (for example, after brain surgery or a shrapnel wound) or any recent (less than three months) brain lesions cannot be included.

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
  • Byl NN, Melnick M. The neural consequences of repetition: clinical implications of a learning hypothesis. J Hand Ther. 1997 Apr-Jun;10(2):160-74. doi: 10.1016/s0894-1130(97)80070-1.

    PMID: 9188035BACKGROUND
  • Fahn S, Bressman SB, Marsden CD. Classification of dystonia. Adv Neurol. 1998;78:1-10. No abstract available.

    PMID: 9750897BACKGROUND

MeSH Terms

Conditions

Dystonic DisordersDystoniaMovement DisordersDystonia, Focal, Task-Specific

Interventions

Constraint Induced Movement Therapy

Condition Hierarchy (Ancestors)

Central Nervous System DiseasesNervous System DiseasesDyskinesiasNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise TherapyPhysical Therapy ModalitiesTherapeuticsRehabilitation

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

August 8, 2001

First Posted

August 9, 2001

Study Start

August 1, 2001

Study Completion

August 1, 2002

Last Updated

March 4, 2008

Record last verified: 2002-08

Locations