RBD Longitudinal as Prognostic for PD

NCT00817726 | Unknown

• 1 other identifier: HSC-MS-08-0147
• Study Type: observational
• Target: 164
• Locations: 1 country
• Sites: 1

Brief Summary

• 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.

Conditions

Rapid Eye Movement Sleep Behavior Disorder

Keywords

Rapid Eye Movement Sleep Behavior Disorder; Parkinson's Disease; Parkinsonian Syndromes; Atypical Parkinson's; RBD; PD; fMRI; PSP; MSA

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Further characterize the sleep behavior patterns, olfactory function, and neurologic assessments of subjects longitudinally, over 5 years, within each group of patients.

  5 years

• functional MRI of the brain and eye tracking testing, identification of distinct features in PD

  beginning of study and at 2 years

• identify key fluid-based PD-associated molecular markers that identify disease state or progression

  5 years

Study Arms (2)

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.

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• year old men \& women
• (1) Diagnosis of idiopathic RBD (see AASM criteria), 2) Normal control or control with a non-neurodegenerative disorder, age and gender-matched to (1)
• Gives written informed consent
• Pregnant women are not excluded, but will be identified by HCG.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

University of texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

blood (serum)

MeSH Terms

Conditions

REM Sleep Behavior Disorder; Parkinson Disease; Parkinsonian Disorders

Condition Hierarchy (Ancestors)

REM Sleep Parasomnias; Parasomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Mya C Schiess, MD

  The University fo texas Health Science Center at Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor - Neurology

Study Record Dates

• First Submitted: January 5, 2009
• First Posted: January 6, 2009
• Study Start: January 1, 2009
• Primary Completion: December 1, 2024
• Study Completion: May 1, 2025
• Last Updated: November 29, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)