Cerebral Palsy Clinical Trial
Official title:
Characteristics and Mechanism of Childhood-Onset Hemidystonia
Verified date | December 20, 2018 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 21 |
Est. completion date | December 20, 2018 |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 7 Years to 40 Years |
Eligibility |
- 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. |
Country | Name | City | State |
---|---|---|---|
United States | National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Institutes of Health Clinical Center (CC) |
United States,
Abbruzzese G, Berardelli A. Sensorimotor integration in movement disorders. Mov Disord. 2003 Mar;18(3):231-40. Review. — View Citation
Aertsen AM, Gerstein GL, Habib MK, Palm G. Dynamics of neuronal firing correlation: modulation of "effective connectivity". J Neurophysiol. 1989 May;61(5):900-17. — View Citation
Albanese A, Barnes MP, Bhatia KP, Fernandez-Alvarez E, Filippini G, Gasser T, Krauss JK, Newton A, Rektor I, Savoiardo M, Valls-Solè J. A systematic review on the diagnosis and treatment of primary (idiopathic) dystonia and dystonia plus syndromes: report of an EFNS/MDS-ES Task Force. Eur J Neurol. 2006 May;13(5):433-44. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Sum of wrist, elbow, and shoulder excursion | |||
Primary | Difference between the peak-to-peak amplitude of MEP due to the TS and the CS for SICI. | |||
Primary | Performance accuracy on sterognosis. | |||
Primary | Maximum excursion and Time to largest hand aperture | |||
Secondary | This protocol has 5 Objectives, each with its own primary and secondary objectives. They are too numerous to list. |
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