RBD Longitudinal as Prognostic for PD (RBD6YR)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00817726|
Recruitment Status : Recruiting
First Posted : January 6, 2009
Last Update Posted : May 4, 2018
- 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 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 for serum testing , 6) functional MRI. All of these procedures are often performed clinically in the diagnosis of PD. Enrollment of subjects with PD is complete. 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. Subjects may be offered a repeat enrollment after 5 years.
|Condition or disease|
|Rapid Eye Movement Sleep Behavior Disorder|
|Study Type :||Observational|
|Estimated Enrollment :||240 participants|
|Official Title:||A Natural History Analysis of Rapid Eye Movement Sleep Behavior Disorder as Prognostic for Parkinson's Disease|
|Study Start Date :||January 2009|
|Estimated Primary Completion Date :||June 2019|
|Estimated Study Completion Date :||June 2019|
polysomnographically diagnosed RBD patients. RBD is a sleep disorder diagnosed by a sleep lab in which the individual has muscle movements during the phase of deep sleep during which the muscles should be relaxed. Suspicion of RBD by history will be confirmed during screening.
2 - control
- Identify the key cognitive and non-motor characteristics for early PD diagnosis [ Time Frame: 5 years ]periodically performed set of clinical and imaging parameters suspected to be linked to PD to see if, as a group, these parameters could identify those at risk for motor symptoms of PD before these symptoms develop.
- Further characterize the sleep behavior patterns, olfactory function, and neurologic assessments of subjects longitudinally, over 5 years, within each group of patients. [ Time Frame: 5 years ]perform baseline sleep study, olfactory testing and clinical neurologic exam followed by periodically performed set of clinical parameters.
- functional MRI of the brain and eye tracking testing, identification of distinct features in PD [ Time Frame: beginning of study and at 2 years ]Perform fMRI at baseline and at 2 years followed by periodically performed set of clinical parameters.
- identify key fluid-based PD-associated molecular markers that identify disease state or progression [ Time Frame: 5 years ]parameters within blood may be present & measurable well before motor symptoms of PD are seen.
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00817726
|Contact: Vicki J Ephron, RN||713-500-7073||Vicki.J.Ephron@uth.tmc.edu|
|Contact: Mya C Schiess, MD||713-500-7121||Mya.C.Schiess@uth.tmc.edu|
|United States, Texas|
|University of texas Health Science Center at Houston||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Vicki J Ephron, RN 713-500-7073 email@example.com|
|Contact: Mya C Schiess, MD 713-500-7121 Mya.C.Schiess@uth.tmc.edu|
|Sub-Investigator: Erin F Stimming, MD|
|Principal Investigator:||Mya C Schiess, MD||The University fo texas Health Science Center at Houston|