RBD Longitudinal as Prognostic for PD (RBD6YR)

A Natural History Analysis of Rapid Eye Movement Sleep Behavior Disorder as Prognostic for Parkinson's Disease

• 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.

Study Overview

• Status: Active, not recruiting
• Conditions: Rapid Eye Movement Sleep Behavior Disorder

Detailed Description

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

• Study Type: Observational
• Enrollment (Actual): 164

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • University of Texas Health Science Center at Houston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients with polysomnographically-documented RBD, non-neurodegenerative diagnosis Age and gender matched non-RBD diagnosis, non-neurodegenerative diagnosis idiopathic PD diagnosis atypical PD diagnosis

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identify the key cognitive and non-motor characteristics for early PD diagnosis	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.	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Further characterize the sleep behavior patterns, olfactory function, and neurologic assessments of subjects longitudinally, over 5 years, within each group of patients.	perform baseline sleep study, olfactory testing and clinical neurologic exam followed by periodically performed set of clinical parameters.	5 years
functional MRI of the brain and eye tracking testing, identification of distinct features in PD	Perform fMRI at baseline and at 2 years followed by periodically performed set of clinical parameters.	beginning of study and at 2 years
identify key fluid-based PD-associated molecular markers that identify disease state or progression	parameters within blood may be present & measurable well before motor symptoms of PD are seen.	5 years

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Investigators: Principal Investigator: Mya C Schiess, MD, The University fo texas Health Science Center at Houston

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2009
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): May 1, 2025

Study Registration Dates

• First Submitted: January 5, 2009
• First Submitted That Met QC Criteria: January 5, 2009
• First Posted (Estimated): January 6, 2009

Study Record Updates

• Last Update Posted (Actual): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 28, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: MSA; Parkinson's Disease; fMRI; PSP; PD; Rapid Eye Movement Sleep Behavior Disorder; Parkinsonian Syndromes; Atypical Parkinson's; RBD
• Additional Relevant MeSH Terms: Nervous System Diseases; Sleep Wake Disorders; Parasomnias; REM Sleep Parasomnias; Mental Disorders; REM Sleep Behavior Disorder
• Other Study ID Numbers: HSC-MS-08-0147

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO