Ignite Creation Date:
2024-05-06 @ 3:48 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04768101
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-14
First Post:
2021-02-16
Brief Title:
Quantitative Imaging of Brain Glymphatic Function in Humans
Sponsor:
Vanderbilt University Medical Center
Organization:
Vanderbilt University Medical Center
Study Overview
Official Title:
Quantitative Imaging of Brain Glymphatic Function in Humans
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Parkinsons disease and Alzheimers 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
Detailed Description:
The proposal involves magnetic resonance imaging MRI of healthy volunteers and patient volunteers suffering from Parkinsons 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None