Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Parkinson Disease
Type
Interventional
Phase
Early Phase 1
Design
Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: There is no masking in this protocol.Masking: None (Open Label)Masking Description: There is no masking in this protocol.Primary Purpose: Basic Science

Participation Requirements

Age
Between 55 years and 80 years
Gender
Both males and females

Description

The proposal involves magnetic resonance imaging (MRI) of healthy volunteers and patient volunteers suffering from Parkinson's disease. As part of the research study, volunteers will undergo 1-2 non-invasive MRI scans at a field strength of 3 Tesla. Each scan session will last 60-90 minutes, and wil...

The proposal involves magnetic resonance imaging (MRI) of healthy volunteers and patient volunteers suffering from Parkinson's disease. As part of the research study, volunteers will undergo 1-2 non-invasive MRI scans at a field strength of 3 Tesla. Each scan session will last 60-90 minutes, and will include the time when the volunteers will rehearse the experiment outside of the scanner, time for the volunteers and patients to be comfortably placed in the scanner, scanning, and finally time for the patients to slowly exit the scan room. All MRI methods are non-invasive and no exogenous contrast agents will be required. Patient volunteers will also undergo an C-11 PiB PET scan for Aim (2). This procedure utilizes a common radiotracer that is used routinely in clinical PET scans and will be purchased here from PETNET and certified for human use. All PET scans will be performed by a certified PET technologist at the Vanderbilt University Institute of Imaging Science. Finally, in Aim (3) of this study, measurements of glymphatic function will be performed before and during general anesthesia. Importantly, the general anesthesia will be administered as part of standard-of-care for clinically-indicated MRIs required for deep brain stimulation planning and electrode placement. Therefore, the intervention itself is not a research procedure. Additionally, the scan that will be performed, which is a modified diffusion tensor imaging (DTI) MRI approach, is already performed as part of this clinical protocol. Therefore, it is anticipated that the participant will not be sedated any longer than what would be required for clinical indication for this procedure. As such, while this study qualifies as a clinical trial by NIH criteria, it is expected to pose no more risk than what the participant will receive from their clinical standard-of-care procedure.

Tracking Information

NCT #
NCT04768101
Collaborators
Not Provided
Investigators
Principal Investigator: Manus J Donahue, Ph.D. Vanderbilt University Medical Center