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 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

Eligibility

Eligible Ages
Between 35 Years and 70 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  1. 35-70 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. 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. Significant dementia (MMSE<25 of 30 or MOCA<25/30) that would interfere with study procedures or informed consent. f. Any reason which, in the opinion of the PI, would increase the risk or decrease the value of any study procedure. g. fMRI will not be performed for anyone for whom the screening questionnaire indicates is ineligible for MRI imaging.

Study Design

Phase
Study Type
Observational
Observational Model
Case-Control
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
1- RBD 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 control: must not have any neurological degenerative diagnosis. must NOT have RBD. must be able to age and/or gender-match to RBD and PD subjects already enrolled.

More Details

Status
Active, not recruiting
Sponsor
The University of Texas Health Science Center, Houston

Study Contact

Detailed Description

Enrollment of PD and PS cohorts is complete. Currently enrolling only confirmed RBD and Controls.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.