Motor Training to Treat Hand Dystonia

NCT ID: NCT00021853

Last Updated: 2008-03-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-08-31

Study Completion Date

2002-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Dystonia is a movement disorder characterized by sustained muscle contractions generating twisting and repetitive movements or abnormal postures. Abnormalities of the motor cortex have been shown in patients with focal hand dystonia. In addition it is well known that dystonic patients have co-contraction of their antagonist muscles, and that individualized finger movements are imprecise and difficult. Motor training such as "constraint-induced movement therapy" has been described to be successful in patients with musician's cramp. We therefore hypothesize that motor training with training of individualized finger movements could improve focal hand dystonia in patients with writer's cramp. We propose to study one group of twelve patients with either pure or dystonic writer's cramp. Patients will receive individualized finger training with immobilization of fingers that are not in training. Evaluation for improvement will be done with a handwriting analysis program developed by Mai and Marquardt, and clinical evaluation with the Fahn-Dystonia Scale.

Transcranial magnetic stimulation (TMS) studies have shown that patients with dystonia have less intracortical inhibition compared with normal subjects, leading to excessive cortical activity and possibly to co-contraction of agonist-antagonist groups of muscles of the forearm resulting in dystonic posturing. Furthermore, studies in other basal ganglia disorders as well as dystonia have suggested that the movement related cortical potentials might show plastic changes that reflect the degree of "successful" performance of a motor task. We therefore would like to evaluate the excitability of the motor cortex before and after the training with TMS and movement related cortical potentials.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Focal Dystonia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Primary Study Purpose

TREATMENT

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

constraint-induced movement therapy

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role lead

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

National Institute of Neurological Disorders and Stroke (NINDS)

Bethesda, Maryland, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 8775368 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9188035 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 9750897 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

01-N-0217

Identifier Type: -

Identifier Source: secondary_id

010217

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Dystonia Coalition Projects
NCT04156022 TERMINATED
Neurotoxin and Physical Therapy
NCT02177617 COMPLETED PHASE4
Assessing Cervical Dystonia
NCT03587350 COMPLETED NA