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View Clinical Trial (Medical Research Study)
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RBD Longitudinal as Prognostic for PD - NCT00817726-77030 (Clinical Trial 262544)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy262544.aspx
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** Please review additional "Nearby Studies" on right ----->
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| City: |
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Houston |
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State:
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TX |
| Zip Code: |
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77030 |
| Conditions: |
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Rapid Eye Movement Sleep Behavior Disorder - Parkinson's Disease |
| Purpose: |
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- 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 idiopathic (sporadic) Parkinson's disease (PD).
- Procedures - All subjects (RBD 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. 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 6 years. It is hypothesized that a 6 year follow up may capture a
significant number of pre-Parkinson's subjects who will be diagnosed.
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| Study summary: |
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| Criteria: |
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Inclusion Criteria:
1. 35-80 year old men & women
2. (1) Diagnosis of idiopathic RBD (see AASM criteria) , or 2) Normal control or
control with a non-neurodegenerative disorder, age and gender-matched to (1).
3. Gives written informed consent
4. Pregnant women are not excluded, but will be identified by HCG.
Exclusion Criteria:
a A diagnosis of any Parkinsonian or 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. |
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| Study is available at: |
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University of texas Health Science Center at Houston
Houston, TX 77030
United States
Primary Contact:
Vicki J Ephron, RN
Email: vicki.j.ephron@uth.tmc.edu
Phone: 713-500-7073
Secondary Contact:
Vicki J Ephron, RN
Email: Vicki.J.Ephron@uth.tmc.edu
Phone: 713-500-7073 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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February 16, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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