RBD Longitudinal as Prognostic for PD (RBD6YR)
- 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. 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.
Rapid Eye Movement Sleep Behavior Disorder
|Study Design:||Observational Model: Case-Crossover
Time Perspective: Prospective
|Official Title:||A Natural History Analysis of Rapid Eye Movement Sleep Behavior Disorder as Prognostic for Parkinson's Disease|
- Identify the key cognitive and non-motor characteristics for early PD diagnosis [ Time Frame: 5 years ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]
- functional MRI of the brain and eye tracking testing, identification of distinct features in PD [ Time Frame: beginning of study ] [ Designated as safety issue: No ]
- identify key fluid-based PD-associated molecular markers that identify disease state or progression [ Time Frame: 5 years ] [ Designated as safety issue: No ]parameters within blood and cerebrospinal fluid may be present & measurable well before motor symptoms of PD are seen.
Biospecimen Retention: Samples With DNA
CSF, blood (serum)
|Study Start Date:||January 2009|
|Estimated Study Completion Date:||June 2016|
|Estimated Primary Completion Date:||June 2016 (Final data collection date for primary outcome measure)|
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
3 - idiopathic PD
early iPD diagnosed patients. Early is defined as within 5 years of diagnosis, and with no surgical interventions for treatment (such as DBS).
4 - Parkinsonian Syndromes
Atypical Parkinsonian Syndromes: MSA, PSP, unspecified parkinsonian diagnoses
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.
Please refer to this study by its ClinicalTrials.gov identifier: 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 firstname.lastname@example.org|
|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|