Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00021853
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2001-08-08
Brief Title:
Motor Training to Treat Hand Dystonia
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Motor Training as Treatment of Focal Hand Dystonia
Status:
COMPLETED
Status Verified Date:
2002-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will evaluate the effect of motor training on focal hand dystonia in people with writers 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 brains 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
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 brains 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:
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 musicians cramp We therefore hypothesize that motor training with training of individualized finger movements could improve focal hand dystonia in patients with writers cramp We propose to study one group of twelve patients with either pure or dystonic writers 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 01-N-0217 | None | None | None |