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Quantitative Imaging of Brain Glymphatic Function in Humans

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ClinicalTrials.gov Identifier: NCT04768101
Recruitment Status : Recruiting
First Posted : February 24, 2021
Last Update Posted : April 8, 2021
Sponsor:
Information provided by (Responsible Party):
Manus Donahue, Vanderbilt University Medical Center

Brief Summary:
Recent immunological and physiological studies have provided evidence in support of a central nervous system (CNS) lymphatic drainage system in vertebrate animals, and preliminary evidence has suggested that a similar system exists in humans. If operative, this system may have central relevance to many vascular and fluid clearance disorders such as stroke, multiple sclerosis, Parkinson's disease, and Alzheimer's disease related dementia (ADRD): diseases which represent some of the most pressing healthcare challenges of the 21st century. Evaluating this possibility will require improved, robust imaging methods sensitive to lymphatic drainage dysfunction; as such, the goal of this work is to apply novel magnetic resonance imaging approaches, optimized already for evaluating lymphatic circulation in patients with peripheral lymphatic dysfunction, to quantify relationships between physiological hallmarks of ADRD and CNS lymphatic function in humans.

Condition or disease Intervention/treatment Phase
Parkinson Disease Drug: C-11 PiB Early Phase 1

Detailed 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 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention 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
Official Title: Quantitative Imaging of Brain Glymphatic Function in Humans
Actual Study Start Date : April 15, 2020
Estimated Primary Completion Date : February 28, 2024
Estimated Study Completion Date : February 28, 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Parkinson's Disease participants with MCI
Patient volunteers will also undergo a C-11 PiB PET scan. 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.
Drug: C-11 PiB
C-11 PiB is a PET radiotracer used to evaluate levels of Αβ burden.




Primary Outcome Measures :
  1. Diffusion Tensor Imaging Along Perivascular Spaces (DTI-ALPS) [ Time Frame: baseline, under anesthesia ]
    Using a 3T MRI (body coil transmission and SENSE phased-array 32-channel reception), images will be taken. For analysis, a unitless ratio of diffusion along perivascular space relative to orthogonal to perivascular space at the level of the lateral brain ventricles will be calculated



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Ages Eligible for Study:   55 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • diagnosis of Parkinson's Disease or controls
  • willing to participate in PET and MRI imaging

Exclusion Criteria:

  • recent stimulant use
  • unstable diabetes
  • prior stroke
  • claustrophobia
  • prior cancer treatment with chemotherapy
  • history of traumatic brain injury
  • any unstable medical condition

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 ClinicalTrials.gov identifier (NCT number): NCT04768101


Contacts
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Contact: Kaitlyn R Hay, M.S. 615-875-7403 kaitlyn.r.hay@vumc.org
Contact: James Silverman, Ph.D. 615-875-5778 james.silverman@vumc.org

Locations
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United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37212
Contact: Kaitlyn Hay, MS    615-875-7403    kaitlyn.r.hay@vumc.org   
Contact: James Silverman, PhD    615-875-5778    james.silverman@vumc.org   
Principal Investigator: Manus J Donahue, Ph.D.         
Sub-Investigator: Daniel O Claassen, M.D.         
Sponsors and Collaborators
Vanderbilt University Medical Center
Investigators
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Principal Investigator: Manus J Donahue, Ph.D. Vanderbilt University Medical Center
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Responsible Party: Manus Donahue, Professor of Neurology, Psychiatry and Behavioral Sciences, and Radiology and Radiological Sciences, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT04768101    
Other Study ID Numbers: Imaging of Brain Glymphatics
First Posted: February 24, 2021    Key Record Dates
Last Update Posted: April 8, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: De-identified individual participant data may be shared upon request by other researchers.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases