Neuroimaging of Dystonia
Information source: University of Florida
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Primary Cervical Dystonia; DYT 1 Dystonia
Intervention: Primary Cervical Dystonia (Trihexyphenidyl) (Drug); Controls Primary Cervical Dystonia (Trihexyphenidyl) (Other); DYT 1 Dystonia (Healthy Control) (Other); DYT 1 Dystonia (Other)
Phase: N/A
Status: Recruiting
Sponsored by: University of Florida Official(s) and/or principal investigator(s): David Vaillancourt, PhD, Principal Investigator, Affiliation: University of Florida Michael Okun, MD, Principal Investigator, Affiliation: University of Florida
Overall contact: Erin Monari, PhD, Phone: 352-294-5030, Email: erin.hastings@neurology.ufl.edu
Summary
The main purpose of this study is to investigate primary cervical dystonia as compared to
healthy control subjects and DYT 1 dystonia as compared to healthy control subjects by
examining cognitive measures, physical measures, and structural and functional magnetic
resonance imaging (MRI).
The secondary aim of this study is to investigate a specific drug therapy for primary
cervical dystonia to develop a functional MRI (fMRI) research paradigm. The drug,
trihexyphenidyl, is FDA approved to treat Parkinson's Disease and is commonly prescribed by
physicians as a treatment for symptoms of primary cervical dystonia.
Clinical Details
Official title: Neuroimaging of Dystonia: The Bachmann-Strauss Dystonia and Parkinson Disease Center of Excellence at the University of Florida
Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science
Primary outcome: Change in cerebral blood flow based on blood-oxygen-level dependent (BOLD) contrast during a precision gripping taskChange 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
Detailed description:
To participate in this study, you will be asked to come to the University of Florida for one
testing day. For your convenience, arrangements will be made by the study coordinator.
If you have a movement disorder, you will be tested in an "off" medication condition. We do
not expect concerns or unwanted consequences arising from discontinuing medications for this
duration.
We will review the informed consent and you will have the opportunity to ask questions
before signing the informed consent. During the experiment, you may be asked to complete
the following: (1) questionnaires about quality of life and depression; (2) tests to measure
your strength and motor function; (3) tests to measure your cognition; (4) functional and
structural MRI scan of your brain while performing a precision gripping task; (5)
intravenous blood draw; (6) urine pregnancy test (if applicable); (7) trial of
anticholinergic therapy drug trihexyphenidyl (if applicable - cervical dystonia only).
Participants with DYT 1 dystonia and healthy controls are not eligible to receive the trial
drug. All women of childbearing potential will be given a urine pregnancy test. The
questionnaire about depression will not be given to subjects under the age of 18.
If you have any metal in your eye or eyes, the researchers may require additional screening
to ensure that it is safe for you to enter the MRI environment. If additional screening is
determined to be necessary, you will be referred to Radiology at Shands UF for an
orbitofrontal x-ray.
Blood will be collected for all subjects, including healthy control subjects. The blood may
be analyzed, at the University of Florida, to assess potential biomarkers for cervical
dystonia and DYT 1 dystonia. Biomarker testing is another way to say genetic testing.
Eligibility
Minimum age: 7 Years.
Maximum age: 70 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Erin Monari, PhD, Phone: 352-294-5030, Email: erin.hastings@neurology.ufl.edu
University of Florida, Gainesville, Florida 32607, United States; Recruiting David Vaillancourt, PhD, Principal Investigator Michael Okun, MD, Principal Investigator
Additional Information
Bachmann-Strauss Dystonia & Parkinson Foundation, Inc. Tyler's Hope for a Dystonia Cure UF Center for Movement Disorders & Neurorestoration
Starting date: May 2014
Last updated: June 1, 2015
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