RBD Longitudinal as Prognostic for PD
| Status: | Recruiting |
|---|---|
| Conditions: | Insomnia Sleep Studies, Parkinsons Disease, Neurology, Psychiatric |
| Therapuetic Areas: | Neurology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 35 - 70 |
| Updated: | 5/6/2018 |
| Start Date: | January 2009 |
| End Date: | June 2019 |
| Contact: | Vicki J Ephron, RN |
| Email: | Vicki.J.Ephron@uth.tmc.edu |
| Phone: | 713-500-7073 |
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.
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.
Enrollment of PD and PS cohorts is complete. Currently enrolling only confirmed RBD and
Controls.
Controls.
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.
We found this trial at
1
site
7000 Fannin St
Houston, Texas 77030
Houston, Texas 77030
(713) 500-4472
Phone: 713-500-7073
University of Texas Health Science Center at Houston The University of Texas Health Science Center...
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