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RBD Longitudinal as Prognostic for PD - NCT00817726-77030(Clinical Trial 262544)



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City:  Houston
State:  
TX
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.
Study is available at: 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
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: ClinicalTrials.gov
Date Processed: March 22, 2011
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