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Enrolling by invitationNCT04258774Updated Jan 16, 2026

The Effect of Respiratory Challenge on the BOLD Signal

An interventional study of Carbon Dioxide in Hypoxia, Brain, Hyperoxia and Hypercapnia, sponsored by Washington University School of Medicine. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-16.

Sponsored by Washington University School of Medicine · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
48
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this research study is to better understand how blood flow and metabolism are different between normal controls and patients with disease.

The investigators will examine brain blood flow and metabolism using magnetic resonance imaging (MRI). The brain's blood vessels expand and constrict to regulate blood flow based on the brain's needs. The amount of expanding and contracting the blood vessels can do varies by age. The brain's blood flow changes in small ways during everyday activities, such as normal brain growth, exercise, or deep concentration. Significant illness or physiologic stress may increase the brain's metabolic demand or cause other bigger changes in blood flow. If blood vessels are not able to expand to give more blood flow when metabolic demand is high, the brain may not get all of the oxygen it needs. In less extreme circumstances, not having as much oxygen as it wants may cause the brain to grow and develop more slowly than it should.

One way to test the ability of the blood vessels to expand is by measuring blood flow while breathing in carbon dioxide (CO2). CO2 causes blood vessels in the brain to dilate without increasing brain metabolism. The study team will use a special mask to control the amount of oxygen and carbon dioxide patients breath in so that we can study how their brain reacts to these changes. This device designed to simulate carbon dioxide levels achieved by a breath-hold and target the concentration of carbon dioxide in the blood in breathing patients. The device captures exhaled gas and provides an admixture of fresh gas and neutral/expired gas to target different carbon dioxide levels while maintaining a fixed oxygen level. The study team will obtain MRI images of the brain while the subjects are breathing air controlled by the device.

02

Conditions studied

  • Hypoxia, Brain
  • Hyperoxia
  • Hypercapnia
  • Hypocapnia

Keywords

  • brain metabolism
  • oxygen extraction fraction
  • cerebral vascular reactivity
  • carbon dioxide
03

In context

Hypoxia, Brain

81 studies on the registry are indexed under Hypoxia, Brain; 19 are open to participants now.

This study's planned enrollment of 48 is below the median of 60 across 55 interventional studies indexed under Hypoxia, Brain.

Browse Hypoxia, Brain studies →

Lead sponsor

Washington University School of Medicine is the lead sponsor of 1,803 studies on the registry; 271 are open to participants now.

Of its 329 completed or terminated interventional studies of FDA-regulated products, 216 (66%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Healthy adult subjects (>18 years old) OR adult patients (>18 years old) diagnosed with vascular pathology of the brain willing to participate and sign a consent form.
  2. Able to participate in MRI scan without sedation
  3. Not on stimulant medications
  4. No psychiatric history, as defined by seeing a psychiatrist for medical evaluation and treatment, or taking anti-depressant medications
  5. No seizure history
  6. May have occasional headaches if not taking a daily preventative medication for headaches
  7. Not on vasodilatory medication, such as sildenafil or verapamil

Exclusion criteria

Exclusion Criteria:

  1. Subjects refusing to undergo testing
  2. Subjects with obstructive or resistive lung disease whose PaCO2 at rest is greater than 50mmHg or whose venous serum bicarbonate is greater than 26 mEq/L
  3. Subjects with pre-existing respiratory or metabolic acidosis
  4. Subjects who require portable oxygen at rest or with exercise
  5. Subjects with chronic heart failure or severe pulmonary disease who are unable to climb one flight of stairs due to shortness of breath
  6. Subjects with severe heart failure or restrictive lung disease with resting respiratory rate over 15 breaths/min 2. Patients that cannot participate in a course of rehabilitation therapy.
  7. Subjects that cannot undergo an MRI scan due to one of the following indications:

    • Pregnancy
    • Obtundation, or Coma
    • Confusion, Delirium, or Dementia
    • Unable to understand or carry out commands regarding keeping still and breathing pattern
    • Increased intracranial pressure due to space occupying lesion or obstruction of outflow of CSF
    • Claustrophobia
    • History of kidney problems
    • Pace makers
    • Skin tattoos
    • Neurostimulators (TENS-unit)
    • Implanted drug infusion device (i.e., insulin pump)
    • Exposure of metal fragments to your eye
    • Artificial heart valves
    • Aneurysm clips
    • Cochlear implants
    • Metallic implants and prosthesis
    • Vascular stent or stent graft
    • History as a metal worker
    • Shrapnel or bullet wounds
    • Dorsal column stimulators
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
48 participants (estimated)

Study arms

  • Active comparator
    Healthy Adults

    Other: Carbon Dioxide

  • Active comparator
    Adults diagnosed with vascular pathology of the brain

    Other: Carbon Dioxide

Interventions

  • OtherCarbon Dioxide

    The study team will administer inhaled carbon dioxide to the participants during an MRI at a level

06

What researchers measure

Primary outcomes

  1. Cerebral Oxygen Metabolism

    Time frame: From the beginning of the MRI scan to the completion of the MRI scan -- 75 minutes.

Secondary outcomes

  1. Cerebrovascular Reactivity

    Time frame: From administration of carbon dioxide to end of inhalation of carbon dioxide -- 15 minutes.

07

Study locations

1 site
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04258774
Responsible party
Sponsor
First posted
Feb 6, 2020
Start date
Jan 29, 2020
Primary completion
Dec 31, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Jan 16, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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