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| Tracking Information | |
|---|---|
| First Received Date ICMJE | August 8, 2001 |
| Last Updated Date | March 3, 2008 |
| Start Date ICMJE | August 2001 |
| Primary Completion Date | |
| Current Primary Outcome Measures ICMJE | |
| Original Primary Outcome Measures ICMJE | |
| Change History | Complete list of historical versions of study NCT00021853 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | |
| Original Secondary Outcome Measures ICMJE | |
| Descriptive Information | |
| Brief Title ICMJE | Motor Training to Treat Hand Dystonia |
| Official Title ICMJE | Motor Training as Treatment of Focal Hand Dystonia |
| 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:
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 | 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. |
| Study Phase | Phase II |
| Study Type ICMJE | Interventional |
| Study Design ICMJE | Treatment, Safety/Efficacy Study |
| Condition ICMJE | Focal Dystonia |
| Intervention ICMJE | Behavioral: constraint-induced movement therapy |
| Study Arms / Comparison Groups | |
| Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Enrollment ICMJE | 15 |
| Completion Date | August 2002 |
| Primary Completion Date | |
| Eligibility Criteria ICMJE | 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. |
| Gender | Both |
| Ages | |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | United States |
| Administrative Information | |
| NCT ID ICMJE | NCT00021853 |
| Responsible Party | |
| Study ID Numbers ICMJE | 010217, 01-N-0217 |
| Study Sponsor ICMJE | National Institute of Neurological Disorders and Stroke (NINDS) |
| Collaborators ICMJE | |
| Investigators ICMJE | |
| Information Provided By | National Institutes of Health Clinical Center (CC) |
| Verification Date | August 2002 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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