Status:
COMPLETED
Studying Childhood-Onset Hemidystonia
Lead Sponsor:
National Institutes of Health Clinical Center (CC)
Conditions:
Dystonia
Cerebral Palsy
Eligibility:
All Genders
7-40 years
Brief Summary
Background: \- Childhood-onset dystonia is caused by a brain injury. It causes muscle contractions and twisting movements that the person with dystonia cannot control. The term hemidystonia is used w...
Detailed Description
Objective In childhood-onset hemidystonia, motor and sensory abnormalities pose a great challenge to voluntary movement. In an effort to inform future methods of treatment of this disorder, this stud...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Age 7 40 years, inclusive
- Good general health, with enough energy to carry out the assessments
- Ability to understand and comply with instructions. Adults must be able to provide their own consent.
- Passive motion of at least 15 degrees extension and 15 degrees flexion from neutral of both wrist joints
- Agreement to not drink caffeine or alcohol for 24 hours before each study session because both agents can modify brain activity and may confound outcome measures.
- Additional inclusion criteria for individuals with dystonia:
- \- Childhood-onset (before 13 years of age) hemidystonia in one wrist. Diagnosis of dystonia will be made based on the Hypertonia Assessment Tool (HAT)
- EXCLUSION CRITERIA:
- Healthy Volunteers:
- Presence of any neurological disorders
- Individuals with Dystonia:
- Botulinum toxin injection in the flexor carpi radialis and extensor carpi radialis in the last 6 months
- Concurrent use of medicines for muscle tone (e.g., baclofen, trihexyphenedyl, dantrolene sodium, tizanidine, or carbidopa/levodopa). If patients are taking these medications daily, the treating physician will be contacted by the MAI to determine if it is acceptable for the subject to temporarily discontinue the medication(s). If the risk of weaning, or stopping the medication is deemed harmless, the MAI and/or treating physician will determine a schedule to wean, or stop the medication. The goal is for the subject to be off medication(s) for 24 hours prior to participating in testing for this study. For these subjects, there will be at least 4 days between scheduled research visits to avoid a prolonged time off medication(s).
- Additional exclusion criteria for TMS:
- Seizure in the last 2 years
- Concurrent use of anti-seizure medication
- Hearing loss
- Cardiac pacemakers, implanted medication pumps, intracardiac lines, or acute, unstable cardiac disease, with intracranial implants (e.g. aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth that cannot be safely removed.
- Additional exclusion criteria for MRI:
- Inability to lie flat on the back for up to 1 hour
- Uncontrolled movements of the head when lying supine as determined by the MAI
- Discomfort being in small spaces for up to 1 hour
- Cardiac pacemakers, implanted medication pumps, intracardiac lines, or acute, unstable cardiac disease, with intracranial implants (e.g. aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth that cannot be safely removed.
- Pregnancy: For any female of childbearing potential, a pregnancy test will be done. Childbearing potential will be determined during the history and physical.
Exclusion
Key Trial Info
Start Date :
September 10 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 20 2018
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT01432899
Start Date
September 10 2011
End Date
December 20 2018
Last Update
December 24 2018
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892