View Clinical Trial (Medical Research Study)
A Natural History Analysis of Rapid Eye Movement Sleep Behavior Disorder as Prognostic for Parkinson's Disease
| City: |
|
Houston |
| State: |
|
Texas |
| Zip Code: |
|
77030 |
| Conditions: |
|
Rapid Eye Movement Sleep Behavior Disorder - Parkinson's Disease - Parkinsonian Disorders |
| Purpose: |
|
- Purpose - to validate a combination of biological and clinical markers in the
rapid-eye-movement (REM) sleep behavior disorder (RBD) population as indicative of the
pre-symptomatic stage of Parkinson's disease (PD).
- Procedures - All subjects (RBD diagnosis, PD diagnosis and controls) will have 1) a
medical and neuro history and physical including videotape of movements, 2)
neuropsychological testing, 3) a sleep study, 4) olfactory testing, 5) blood draw & LP
for serum and CSF testing, 6) functional MRI, & 7) eye tracking test OR CANTAB
cognitive testing. All of these procedures are often performed clinically in the
diagnosis of PD. Any testing performed prior to enrollment as part of the clinical
evaluation may be used in place of repeating the procedure for the study. Subjects
will be followed for 5 years. It is hypothesized that a 5 year follow up may capture a
significant number of pre-Parkinson's subjects who will be diagnosed. Changes over
time in the PD population may also capture significant information.
|
| Study Summary: |
|
Atypical Parkinsonian syndromes have been added as a cohort. It is not yet known whether
people diagnosed with RBD may go on to have iPD (classic symptoms of PD) or an atypical
form.
|
| Criteria: |
|
Inclusion Criteria:
1. 35-75 year old men & women
2. (1) Diagnosis of idiopathic RBD (see AASM criteria), 2) Normal control or control
with a non-neurodegenerative disorder, age and gender-matched to (1), (3)
idiopathic PD, or (4) atypical parkinsonian syndrome.
3. Gives written informed consent
4. Pregnant women are not excluded, but will be identified by HCG.
Exclusion Criteria:
a A diagnosis of any non-Parkinsonian Neurodegenerative Disease.
b. Any unstable or uncontrolled medical or psychiatric condition.
c. Parasomnia or RBD not idiopathic, eg., secondary to metabolic derangement or medicine
effect.
d. Renal (creatinine over 1.6) or hepatic insufficiency (LFT significantly out of range),
or a history of significant uncontrolled cardiac disease.
e. IF there is a history or evidence of coagulopathy, on medications such as Plavix,
Aggrenox, heparin, coumadin, or large doses of aspirin, must be able to remain off these
medications for at least 3 days, and have stable blood coagulation values prior to any
research or clinically performed lumbar puncture.
f. Significant dementia (MMSE<25 of 30 or MOCA<25/30) that would interfere with study
procedures or informed consent.
g. Active infections including skin, respiratory or GI infections, and HIV+ (if
undergoing an LP).
h. Any reason which, in the opinion of the PI, would increase the risk or decrease the
value of any study procedure.
i. fMRI will not be performed for anyone for whom the screening questionnaire indicates
is ineligible for MRI imaging.
|
| NCT ID: |
|
NCT00817726 |
| Primary Contact: |
|
Principal Investigator
Mya C Schiess, MD
The University fo texas Health Science Center at Houston
Vicki J Ephron, RN
Phone: 713-500-7073
Email: Vicki.J.Ephron@uth.tmc.edu
|
| Backup Contact: |
|
Email: Mya.C.Schiess@uth.tmc.edu
Mya C Schiess, MD
Phone: 713-500-7121
|
| Location Contact: |
|
Houston, Texas 77030
United States
Vicki J Ephron, RN
Phone: 713-500-7073
Email: vicki.j.ephron@uth.tmc.edu
Site Status: Recruiting |
| Data Source: |
|
ClinicalTrials.gov |
| Date Processed: |
|
May 21, 2013 |
| Modifications to this listing: |
|
Only selected fields are shown, please use the link
below to view all information about this clinical trial. |
|
Click to view Full Listing
|