Studying Childhood-Onset Hemidystonia

Completed

Conditions studied: Dystonia, Cerebral Palsy

In brief

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 when only one side of the body is affected. When dystonia starts during childhood, the brain and nerves may not develop normally. People with hemidystonia can become disabled because of the unwanted postures and twisting that dystonia causes. More research is needed to determine how dystonia affects brain development. Objectives: \- To study brain function in people with hemidystonia. Eligibility: * Individuals between 18 and 40 years of age who developed hemidystonia before age 13. Only one wrist may be affected by hemidystonia, and participants must have at least some movement in that wrist. * Healthy volunteers at least 18 years of age. Design: * This study requires five visits to the NIH Clinical Center: a screening visit and four study visits. Each visit will last up to 3 hours. Visits will be scheduled about once a week. The study procedures may be done in any order. * Participants will be screened with a physical exam and medical history. * Participants will have the following tests: * Brain magnetic resonance imaging scan. During the scan, participants will be asked to move their hand at the wrist when they hear a tone. * Motor tests of arm movement, balance, and walking. These tests may also examine nerve development and muscle tone. * Two transcranial magnetic stimulation sessions to study the electrical activity of the muscles and brain. These sessions may also involve sensory tests. Participants will have hearing tests before the first session and after the second session. * No treatment for hemidystonia will be provided as part of this study.

Key facts

Study ID

NCT01432899

Run by

National Institutes of Health Clinical Center (CC)

People needed

21

Starts

2011-09-10

Expected to finish

2018-12-20

Last updated by the study team

2018-12-24

Who can join

Age: 7 and older, up to 40. Sex: any. Healthy volunteers: accepted.

You may not qualify if…

• 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.

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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