Trial record 1 of 32 for:    rapid eye movement sleep parkinson's
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RBD Longitudinal as Prognostic for PD (RBD6YR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT00817726
Recruitment Status : Recruiting
First Posted : January 6, 2009
Last Update Posted : April 21, 2017
Information provided by (Responsible Party):
Mya Schiess, The University of Texas Health Science Center, Houston

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, 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 for serum 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.

Condition or disease
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
Estimated Enrollment : 240 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: A Natural History Analysis of Rapid Eye Movement Sleep Behavior Disorder as Prognostic for Parkinson's Disease
Study Start Date : January 2009
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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


  • 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.

Primary Outcome Measures :
  1. Identify the key cognitive and non-motor characteristics for early PD diagnosis [ Time Frame: 5 years ]
    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 :
  1. 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 ]
    perform baseline sleep study, olfactory testing and clinical neurologic exam followed by periodically performed set of clinical parameters.

  2. functional MRI of the brain and eye tracking testing, identification of distinct features in PD [ Time Frame: beginning of study and at 2 years ]
    Perform fMRI at baseline and at 2 years followed by periodically performed set of clinical parameters.

  3. identify key fluid-based PD-associated molecular markers that identify disease state or progression [ Time Frame: 5 years ]
    parameters within blood may be present & measurable well before motor symptoms of PD are seen.

Biospecimen Retention:   Samples With DNA
blood (serum)

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00817726

Contact: Vicki J Ephron, RN 713-500-7073
Contact: Mya C Schiess, MD 713-500-7121

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   
Contact: Mya C Schiess, MD    713-500-7121   
Sub-Investigator: Erin F Stimming, MD         
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Principal Investigator: Mya C Schiess, MD The University fo texas Health Science Center at Houston

Responsible Party: Mya Schiess, Professor - Neurology, The University of Texas Health Science Center, Houston Identifier: NCT00817726     History of Changes
Other Study ID Numbers: SchiessRBD6YR2008
First Posted: January 6, 2009    Key Record Dates
Last Update Posted: April 21, 2017
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Mya Schiess, The University of Texas Health Science Center, Houston:
Rapid Eye Movement Sleep Behavior Disorder
Parkinson's Disease
Parkinsonian Syndromes
Atypical Parkinson's

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