Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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 Design

Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00021853
Study type Interventional
Source National Institutes of Health Clinical Center (CC)
Contact
Status Completed
Phase Phase 2
Start date August 2001
Completion date August 2002

See also
  Status Clinical Trial Phase
Completed NCT04692285 - Electrophysiological and Neuroimaging Correlates of the Effect of Zolpidem in Patients With Focal Dystonia Phase 1
Completed NCT00505323 - Motor and Premotor Cortex Stimulation for Treatment of Secondary Focal Dystonia With Striato Palliadal Lesion : Evaluation of Safety and Effectiveness Phase 1
Terminated NCT03206112 - Loss of Depotentiation in Focal Dystonia
Completed NCT00025701 - EEG and EMG Studies of Hand Dystonia N/A
Completed NCT02334683 - Compare Two Guidance Techniques for Botulinum Toxin Injections for the Treatment of Limb Spasticity and Focal Dystonia N/A
Completed NCT03797638 - Characterization of Manual Dexterity by Finger Force Manipuladum (FFM) in Patients With Writer's Cramp and in Control Subjects N/A
Terminated NCT01750346 - Acetyl Hexapeptide-8 for Blepharospasm Phase 2
Completed NCT01738581 - rTMS and Retraining in Focal Hand Dystonia Phase 1/Phase 2
Terminated NCT02106936 - Depotentiation in People With Focal Hand Dystonia N/A
Completed NCT00310414 - fMRI Studies of Task Specificity in Focal Hand Dystonia N/A
Completed NCT00309010 - Neurophysiology of Task-Specificity of Focal Hand Dystonia N/A
Completed NCT03471923 - Non-Motor Features of Cervical Dystonia (CD)
Completed NCT00306865 - Brain Changes in Patients With Focal Hand Dystonia N/A
Completed NCT00411255 - Brain Stimulation to Treat Blepharospasm or Meige Syndrome Phase 2
Terminated NCT00487383 - Brain Changes in Blepharospasm
Recruiting NCT05095740 - Effects of Neuromodulation in Laryngeal Dystonia N/A
Completed NCT00713414 - Role of Neurotransmission and Functional CNS Networks in Spasmodic Dysphonia
Completed NCT00942851 - A Study of Acetyl Hexapeptide-8 (AH8) in Treatment of Blepharospasm Phase 1/Phase 2
Completed NCT00118586 - Neuropathology of Spasmodic Dysphonia
Completed NCT02326818 - Comparison of Electrophysiologic and Ultrasound Guidance for Onabotulinum Toxin A Injections in Focal Upper Extremity Dystonia and Spasticity Phase 3