Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
15 participants
INTERVENTIONAL
2001-08-31
2002-08-31
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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TREATMENT
Interventions
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constraint-induced movement therapy
Eligibility Criteria
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Inclusion Criteria
ALL
No
Sponsors
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National Institute of Neurological Disorders and Stroke (NINDS)
NIH
Locations
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National Institute of Neurological Disorders and Stroke (NINDS)
Bethesda, Maryland, United States
Countries
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References
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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.
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.
Fahn S, Bressman SB, Marsden CD. Classification of dystonia. Adv Neurol. 1998;78:1-10. No abstract available.
Other Identifiers
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01-N-0217
Identifier Type: -
Identifier Source: secondary_id
010217
Identifier Type: -
Identifier Source: org_study_id
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