Carbon Dioxide Administration and Brain Waste Clearance

Part of paid clinical trials in Albuquerque, New Mexico.

Sponsor
Andrew Mayer
Study ID
NCT07357090
Status
Recruiting

Conditions

  • Aging Disorder
  • Magnetic Resonance Imaging (MRI)
  • Traumatic Brain Injury

Eligibility Criteria

Sex
ALL
Age
18 Years - 82 Years
Healthy Volunteers
Accepted

Interventions

  • Hypercapnia task performed during fMRI — OTHER
    This study looks at different levels of carbon dioxide (CO2) exposure (changes of approximately 5 or 10 mmHg) on the brain and proteins in blood, in response to a hypercapnia task while participants undergo MRI. This sequence will dynamically mix gases to target an increase of 5 or 10 mmHg in ETCO2 (increase of \~5-7% CO2 and equal decrease in nitrogen) while keeping O2 constant.

Study Details

The current study tests whether different exposures to carbon dioxide (CO2) can safely result in the increased movement of proteins from the brain into the blood. The investigators believe that this would be a proxy for the brain clearing waste products more effectively. The current study will use a counter-balanced design, in which individuals with and without a history of traumatic brain injury (TBI) will receive different levels of CO2 (targeted changes of approximately 5 or 10 mmHG in end-tidal CO2) approximately one week apart. The counter-balanced design means that each participant receives a single dose of CO2 at each visit, and different doses of CO2 at each visit. The order in which participants receive the dose is randomized, and the participant will not be informed of the dose.

Key Dates

Start date
Apr 30, 2026
Status verified
Dec 2025
Primary completion
Jan 31, 2031
Completion
Feb 29, 2032

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Individuals with TBI
    A counter-balanced, cross-over design (AB/BA), in which individuals with TBI (aged 18-82 years) may be dosed to achieve 5 or 10 mmHG changes in ETCO2 across multiple visits.
  • Experimental: Healthy Subjects
    A counter-balanced, cross-over design (AB/BA), in which individuals without a history of TBI (healthy subjects, aged 18-82 years) may be dosed to achieve 5 or 10 mmHG changes in ETCO2 across multiple visits.

Primary Outcome Measure

Cerebrovascular Reactivity (CVR), vascular-elicited bulk cerebral spinal fluid (VE-bCSF) [ Time Frame: 2.5 hours post-intervention. Data will be reported at the conclusion of the study for all participants. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The Mind Research NetworkAlbuquerqueNew Mexico87106
Jody Roberts, MS
505-272-5028
Andrew Mayer, Phd (PRINCIPAL_INVESTIGATOR)

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