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The Effect of Respiratory Challenge on the BOLD Signal

Primary Purpose

Hypoxia, Brain, Hyperoxia, Hypercapnia

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Carbon Dioxide
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hypoxia, Brain focused on measuring brain metabolism, oxygen extraction fraction, cerebral vascular reactivity, carbon dioxide

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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:

  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

Sites / Locations

  • Washington University of St. Louis

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Healthy Adults

Adults diagnosed with vascular pathology of the brain

Arm Description

Outcomes

Primary Outcome Measures

Cerebral Oxygen Metabolism

Secondary Outcome Measures

Cerebrovascular Reactivity

Full Information

First Posted
February 3, 2020
Last Updated
April 26, 2023
Sponsor
Washington University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT04258774
Brief Title
The Effect of Respiratory Challenge on the BOLD Signal
Official Title
The Effect of Respiratory Challenge on the BOLD Signal
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
January 29, 2020 (Actual)
Primary Completion Date
December 31, 2027 (Anticipated)
Study Completion Date
December 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoxia, Brain, Hyperoxia, Hypercapnia, Hypocapnia
Keywords
brain metabolism, oxygen extraction fraction, cerebral vascular reactivity, carbon dioxide

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
All arms will receive the same study conditions.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Healthy Adults
Arm Type
Active Comparator
Arm Title
Adults diagnosed with vascular pathology of the brain
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Carbon Dioxide
Intervention Description
The study team will administer inhaled carbon dioxide to the participants during an MRI at a level
Primary Outcome Measure Information:
Title
Cerebral Oxygen Metabolism
Time Frame
From the beginning of the MRI scan to the completion of the MRI scan -- 75 minutes.
Secondary Outcome Measure Information:
Title
Cerebrovascular Reactivity
Time Frame
From administration of carbon dioxide to end of inhalation of carbon dioxide -- 15 minutes.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Able to participate in MRI scan without sedation Not on stimulant medications No psychiatric history, as defined by seeing a psychiatrist for medical evaluation and treatment, or taking anti-depressant medications No seizure history May have occasional headaches if not taking a daily preventative medication for headaches Not on vasodilatory medication, such as sildenafil or verapamil Exclusion Criteria: Subjects refusing to undergo testing 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 Subjects with pre-existing respiratory or metabolic acidosis Subjects who require portable oxygen at rest or with exercise Subjects with chronic heart failure or severe pulmonary disease who are unable to climb one flight of stairs due to shortness of breath 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. 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
Facility Information:
Facility Name
Washington University of St. Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

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The Effect of Respiratory Challenge on the BOLD Signal

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