Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT01432899 : Studying Childhood-Onset Hemidystonia
PhaseN/A
AgesMin: 7 Years Max: 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.
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT01432899      |      Link to official Clinicaltrials.gov listing
Locations



Home | Brain Tumor Guide | FAQs | Find A Treatment
Noteworthy Treatments | News | Virtual Trial | Videos | Novocure Optune® | Newsletter
Donations | Brain Tumor Centers | Survivor Stories | Temodar®
Fundraising For Research | Unsubscribe | Contact Us

Copyright (c) 1993 - 2019 by:
The Musella Foundation For Brain Tumor Research & Information, Inc
1100 Peninsula Blvd
Hewlett, NY 11557
888-295-4740