RBD Longitudinal as Prognostic for PD (RBD6YR)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by The University of Texas Health Science Center, Houston
Sponsor:
Information provided by (Responsible Party):
Mya Schiess, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT00817726
First received: January 5, 2009
Last updated: September 2, 2014
Last verified: September 2014
  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, 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.

Condition
Rapid Eye Movement Sleep Behavior Disorder
Parkinson's Disease
Parkinsonian Syndromes

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by The University of Texas Health Science Center, Houston:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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)


Estimated Enrollment: 120
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)
Groups/Cohorts
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.
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   35 Years to 70 Years
Genders Eligible for Study:   Both
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

Criteria

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) idiopathic PD, or (4) atypical parkinsonian syndrome.
  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. IF there is a history or evidence of coagulopathy, on medications such as Plavix, Aggrenox, heparin, coumadin, or large doses of aspirin, must be able to remain off these medications for at least 3 days, and have stable blood coagulation values prior to any research or clinically performed lumbar puncture.

f. Significant dementia (MMSE<25 of 30 or MOCA<25/30) that would interfere with study procedures or informed consent.

g. Active infections including skin, respiratory or GI infections, and HIV+ (if undergoing an LP).

h. Any reason which, in the opinion of the PI, would increase the risk or decrease the value of any study procedure.

i. fMRI will not be performed for anyone for whom the screening questionnaire indicates is ineligible for MRI imaging.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00817726

Contacts
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

Locations
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    vicki.j.ephron@uth.tmc.edu   
Contact: Mya C Schiess, MD    713-500-7121    Mya.C.Schiess@uth.tmc.edu   
Sub-Investigator: Erin F Stimming, MD         
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
Principal Investigator: Mya C Schiess, MD The University fo texas Health Science Center at Houston
  More Information

No publications provided

Responsible Party: Mya Schiess, Professor - Neurology, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT00817726     History of Changes
Other Study ID Numbers: SchiessRBD6YR2008
Study First Received: January 5, 2009
Last Updated: September 2, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by The University of Texas Health Science Center, Houston:
Rapid Eye Movement Sleep Behavior Disorder
Parkinson's Disease
Parkinsonian Syndromes
Atypical Parkinson's
RBD
PD
fMRI
PSP
MSA

Additional relevant MeSH terms:
Parkinsonian Disorders
Disease
Mental Disorders
Parkinson Disease
REM Sleep Behavior Disorder
Syndrome
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Movement Disorders
Nervous System Diseases
Neurodegenerative Diseases
Parasomnias
Pathologic Processes
REM Sleep Parasomnias
Sleep Disorders

ClinicalTrials.gov processed this record on October 22, 2014