Using carbon dioxide to promote brain waste clearance

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults aged 18–82 with and without chronic traumatic brain injury will undergo two counter-balanced sessions in which breathing gases are adjusted to raise end-tidal CO2 by about 5 or 10 mmHg while they have an fMRI. Each participant receives both CO2 levels in randomized order roughly one week apart, with participants blinded to the dose. High-sensitivity proteomic assays will measure baseline and post-CO2 protein levels in blood as a surrogate for brain waste efflux, and cerebrovascular measures from MRI will probe mechanisms. The study tests dose-dependence of CO2-induced protein efflux and how individual cerebrovascular function or brain atrophy modify the response.

Why it matters

Who can join: the full rules

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.

Where it's running

• The Mind Research Network
  Albuquerque, New Mexico, United States Recruiting

Study contacts

• Principal investigator: Andrew R Mayer, Phd — Mind Research Network
• Study coordinator: Sadie LaBauve, PhD
• Email: slabauve@mrn.org
• Phone: 505-272-8739

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.