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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00310414 |
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Date of registration:
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31/03/2006 |
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Primary sponsor: |
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Public title:
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fMRI Studies of Task Specificity in Focal Hand Dystonia
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Scientific title:
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fMRI Studies of Task Specificity in Focal Hand Dystonia |
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Date of first enrolment:
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March 2006 |
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Target sample size:
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51 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00310414 |
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Study type:
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Observational |
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Study design:
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N/A
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Countries of recruitment
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United States
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Contacts
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Name:
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Kenneth H Fischbeck, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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National Institute of Neurological Disorders and Stroke (NINDS) |
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Key inclusion & exclusion criteria
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- INCLUSION CRITERIA:
Focal Dystonia Subjects must be:
- Right hand dominant
- Between 18 and 65 years old
- Diagnosed with mild, simple focal hand dystonia. For this study mild, simple focal
hand dystonia suggests that the patient does not present symptoms when performing
tasks other than writing. Additionally, the patient should be able to write for 20
seconds consecutively
- Willing to abstain from alcohol 48 hours prior to the study
Volunteers must be:
- Healthy right-handed dominant individuals
- Between 18 and 65 years old
- Willing to abstain from alcohol 48 hours prior to the study
EXCLUSION CRITERIA:
- Subjects with implanted devices such as pacemakers, medication pumps or
defibrillators, metal in the cranium except mouth, intracardiac lines, history of
shrapnel injury or any other condition/device that may be contraindicated or prevent
the acquisition of MRI
- Subjects with any finding on the MRI safety questionnaire which prevents them from
safely undergoing an MRI scan
- Subjects who are pregnant.
- Subjects with claustrophobia or other restrictions which prevent them from undergoing
a scan in a confined space for up to 60 minutes
- Subjects with any visual, motor, or hearing difficulties
- Subjects with severe focal hand dystonia i.e., subjects who experience dystonic
spasms in tasks other than/in addition to writing
- Subjects with mirror dystonia
- Subjects without the capacity to give consent
- Subjects with any history of a severe medical condition, such as cardiovascular
disease, which will prevent them from lying flat for up to 60 minutes.
- Subjects with any history of brain tumor, stroke, head trauma or vascular
malformation as obtained by history or from imaging studies.
- Subjects who have had recent (within 3 months) Botulinum Toxin (Botox) injections.
- Subjects who are on anti-parkinsonian drugs
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Focal Dystonia
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Secondary ID(s)
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06-N-0128
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060128
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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