Carbon Dioxide for Traumatic Brain Injury

(COPETBI Trial)

Overseen By Andrew Mayer R The Mind Research Network, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Andrew Mayer

Disqualifiers: Alzheimer's, Epilepsy, Bipolar, Asthma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 2 weeks

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Andrew R Mayer, Phd

Principal Investigator

Mind Research Network

Are You a Good Fit for This Trial?

This trial is for adults aged 18-82, with or without a history of traumatic brain injury (TBI). Participants must be able to consent. For the TBI group, any severity level of adult-onset TBI is acceptable. Healthy individuals can also join.

Inclusion Criteria

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).

I am between 18 and 82 years old and can consent to participate.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive different levels of CO2 to assess brain waste clearance

2 weeks

Multiple visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2.5 hours post-intervention

Blood draws and cognitive assessments

What Are the Treatments Tested in This Trial?

Interventions

• Carbon Dioxide Administration

Trial Overview

The study examines if varying CO2 levels during an fMRI can enhance the brain's waste removal process. Each participant will experience different CO2 levels in a random order across visits, not knowing which dose they receive each time.

How Is the Trial Designed?

Group I: Individuals with TBI Experimental Treatment 1 Intervention

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.

Group II: Healthy Subjects Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Andrew Mayer

Lead Sponsor