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Main
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Note: This record shows only 22 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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8 January 2018 |
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Main ID: |
NCT02046447 |
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Date of registration:
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23/01/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Neuroimaging of Dystonia
NID |
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Scientific title:
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Neuroimaging of Dystonia: The Bachmann-Strauss Dystonia and Parkinson Disease Center of Excellence at the University of Florida |
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Date of first enrolment:
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May 2014 |
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Target sample size:
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20 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02046447 |
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Study type:
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Observational |
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Study design:
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Phase:
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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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David Vaillancourt, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Florida |
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Name:
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Michael Okun, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Florida |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Diagnosis of primary cervical dystonia and between the ages of 18-70, OR
- Diagnosis of DYT 1 dystonia and between the ages of 7-50, OR
- Healthy control and between the ages of 7-70
Exclusion Criteria:
- Neurological impairment from: seizure disorders, stroke, hypertension, heart disease,
diabetes, traumatic brain injury (TBI), drug abuse, nerve disorders, dementia,
Parkinson's Disease, dementia
- Not a candidate for magnetic resonance imaging (MRI)
- Deep brain stimulation (DBS) surgery
- Any implanted electrical device
- Pregnant or planning pregnancy
- Breastfeeding
- Claustrophobia
Age minimum:
7 Years
Age maximum:
70 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Primary Cervical Dystonia
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DYT 1 Dystonia
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Intervention(s)
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Other: DYT 1 Dystonia (Healthy Control)
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Drug: Primary Cervical Dystonia (Trihexyphenidyl)
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Other: DYT 1 Dystonia
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Other: Controls Primary Cervical Dystonia (Trihexyphenidyl)
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Primary Outcome(s)
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Change in cerebral blood flow based on blood-oxygen-level dependent (BOLD) contrast during a precision gripping task
[Time Frame: 1 hour]
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Change in cerebral blood flow based on blood-oxygen-level dependent (BOLD) contrast during a precision gripping task after administration of trihexyphenidyl compared to change in BOLD contrast during a precision gripping task
[Time Frame: 2 hours]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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