Recruiting

CO2

Sponsor:

Andrew Mayer

Code:

NCT07357090

Conditions

Traumatic Brain Injury

Aging Disorder

Magnetic Resonance Imaging (MRI)

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Hypercapnia task performed during fMRI

Study Details

Brief summary:

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.

Conditions

Traumatic Brain Injury

Aging Disorder

Magnetic Resonance Imaging (MRI)

Study ID

NCT07357090

Start date

Apr, 2026

Status verified date

Dec, 2025

Completion date

Feb, 2032

Anticipated

Primary completion date

Jan, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Inclusion criteria for TBI cohort: 1) Able to give valid informed consent, 2) 18-82 years old, 3) history of TBI of any severity level (mild, moderate or severe) that was sustained in adulthood (age 18 and older), which will be confirmed using a semi-structured identification method (includes asking about loss of consciousness, posttraumatic amnesia, and feeling dazed/confused).

Inclusion criteria for Healthy Subjects cohort: 1) Able to give valid informed consent and 2) 18-82 years old years old.

Exclusion criteria for TBI cohort: 1) contraindications to MRI scanning including pregnancy or claustrophobia, 2) unable to give valid informed consent, incarcerated, 3) diagnosed with Alzheimer's, ADRD or mild cognitive impairment, 4) pre-existing history of autism spectrum disorders, intellectual disability, serious neurological (e.g., epilepsy, tumors, other conditions requiring neurosurgery) or psychiatric disorders (requiring hospitalization) prior to TBI onset, 5) current or previous diagnosis of a psychosis spectrum disorder or bipolar disorder, 6) respiratory diseases or pulmonary conditions that may increase the risk of study procedures (e.g., severe asthma, chronic obstructive pulmonary disease or other significant respiratory disorders), 7) a history of cardiac arrythmias 8) history of a current substance use disorder, 9) non-English fluency (based on screener), 10) Weigh under 110 pounds for blood draw.

Exclusion criteria for Healthy Subjects cohort: 1) contraindications to MRI scanning including pregnancy or claustrophobia, 2) unable to give valid informed consent, incarcerated, 3) diagnosed with Alzheimer's, ADRD or mild cognitive impairment, 4) history of developmental, neurological, or psychiatric disorders requiring hospitalization, 5) regular use of any substance in the past six months (i.e., no current use confirmed with urine screening), 6) previous head injury with greater than 30 minutes loss of consciousness, 7) respiratory diseases or pulmonary conditions that may increase the risk of study procedures (e.g., severe asthma, chronic obstructive pulmonary disease or other significant respiratory disorders), 8) a history of cardiac arrythmias, 9) non-English fluency (based on screener), 10) Weigh under 110 pounds for blood draw.

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

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.

Interventions

Hypercapnia task performed during fMRI

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.

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. ]
  • Protein Efflux (Surrogate Measure of Brain Waste Clearance) [ Time Frame: Blood will be drawn at baseline, immediately prior to hypercapnia, 45 minutes post-hypercapnia, 90 minutes post-hypercapnia and 150 minutes post-hypercapnia. Data will be reported at the conclusion of the study for all participants. ]

Central Contacts and Locations

Central contacts

Andrew Mayer R The Mind Research Network, PhD

505-272-0769amayer@mrn.org

Locations

The Mind Research Network

Recruiting

Albuquerque, New Mexico, United States, 87106

Contacts

Principal Investigator:

Andrew Mayer, Phd

More Information

Sponsor

Andrew Mayer

Last update posted

Feb 23, 2026

Last verified

Dec, 2025

Keywords

  • Traumatic Brain Injury
  • Magnetic Resonance Imaging

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Andrew Mayer on 2026-02-23.