Primary Cervical Dystonia Clinical Trial
Official title:
Neuroimaging of Dystonia: The Bachmann-Strauss Dystonia and Parkinson Disease Center of Excellence at the University of Florida
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.
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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03369613 -
Transcranial Electrical Stimulation for Cervical Dystonia
|
N/A | |
| Completed |
NCT02542839 -
rTMS and Botulinum Toxin in Primary Cervical Dystonia
|
N/A |