Glymphatic MRI Study | NCT06452459

Studies
Glymphatic MRI Study

NCT06452459

Sponsor

Oregon Health and Science University

Status

Not yet recruiting

Last Update Posted

Jun 11, 2024Actual

Enrollment

10Estimated

Phase

Not provided

Conditions

Sleep Deprivation

Interventions

No interventinon

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2024

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2024Estimated

Primary Completion Date

Jul 1, 2027Estimated

Completion Date

Jul 1, 2028Estimated

First Submitted Date

Jun 5, 2024

First Submission Date that Met QC Criteria

Jun 5, 2024

First Posted Date

Jun 11, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 5, 2024

Last Update Posted Date

Jun 11, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Juan Piantino, Associate Professor, Oregon Health and Science UniversityPrincipal Investigator

Lead Sponsor

Oregon Health and Science UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

10Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No interventinon	Other	No intervention is anticipated. This is an observational study.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Contrast enhancement	Measurement of contrast intensity in brain parenchyma	2 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Ability to undergo MRI without anesthesia
Calculated GFR greater or equal to 60 mL/min/1.73 m2

Exclusion Criteria:

Inability to obtain consent
Subject is incarcerated, pregnant, or lactating or suspects they may be pregnant
Known allergic or hypersensitivity reactions to gadolinium
Three or more drug allergies from separate drug classes
Recent or expected beed for imaging with iodinated contrast
Contraindications to MRI: claustrophobia, weight greater than maximum MRI scanner capacity, presence of metallic foreign body, or implanted devices not documented as MRI safe
History of neurosurgical procedure or cervical surgery
Current use of anticoagulation medications
Contraindication to lumbar puncture (creatinine or INR elevated above laboratory standard cutoffs)

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

89 Years

Standard Ages

AdultOlder Adult

Study Population

Healthy adults

Sampling Method

Non-Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012892	Sleep Deprivation

Ancestor Terms

ID	Term
D020920	Dyssomnias
D012893	Sleep Wake Disorders
D009422	Nervous System Diseases
D009461	Neurologic Manifestations

Browse Leaves

Not provided

Browse Branches

Not provided