- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04258774
The Effect of Respiratory Challenge on the BOLD Signal
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Missouri
-
Saint Louis, Missouri, United States, 63110
- Washington University of St. Louis
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Healthy Adults
|
The study team will administer inhaled carbon dioxide to the participants during an MRI at a level
|
Active Comparator: Adults diagnosed with vascular pathology of the brain
|
The study team will administer inhaled carbon dioxide to the participants during an MRI at a level
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Cerebral Oxygen Metabolism
Time Frame: From the beginning of the MRI scan to the completion of the MRI scan -- 75 minutes.
|
From the beginning of the MRI scan to the completion of the MRI scan -- 75 minutes.
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Cerebrovascular Reactivity
Time Frame: From administration of carbon dioxide to end of inhalation of carbon dioxide -- 15 minutes.
|
From administration of carbon dioxide to end of inhalation of carbon dioxide -- 15 minutes.
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201910105
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hypoxia, Brain
-
Western University, CanadaUnknownBrain Hypoxia IschemiaCanada
-
Yale UniversityTianjin Chest HospitalCompletedBrain Ischemia Hypoxia | Muscle; Ischemic | Muscle HypoxiaChina
-
University Hospital, GrenobleCompleted
-
University of MinnesotaCompletedBrain HypoxiaUnited States
-
Fliegerärztliches InstitutCompleted
-
Montreal Heart InstituteUniversité de MontréalCompleted
-
Hospital Universitario Dr. Jose E. GonzalezCompleted
-
Hamilton Health Sciences CorporationMcMaster UniversityNot yet recruitingHypoxia-Ischemia, Brain | Hypoxic-Ischemic Encephalopathy | Hypoxia Ischemia, Cerebral | Hypoxia NeonatalCanada
-
Children's Hospital of PhiladelphiaBracco Diagnostics, IncRecruitingHypoxic-Ischemic Encephalopathy | Brain Ischemia HypoxiaUnited States
-
Gachon University Gil Medical CenterWithdrawnCerebral Ischemia-HypoxiaKorea, Republic of
Clinical Trials on Carbon Dioxide
-
SMG-SNU Boramae Medical CenterUnknownVentilation Perfusion Mismatch
-
Meshalkin Research Institute of Pathology of CirculationUnknownCarbon DioxideRussian Federation
-
Rutgers, The State University of New JerseyCompleted
-
Washington University School of MedicineRecruiting
-
Imperial College LondonUnknown
-
Imperial College LondonUnknownHeart Failure | Periodic BreathingUnited Kingdom
-
Imperial College LondonImperial College Healthcare NHS TrustUnknownSleep Apnea, CentralItaly, United Kingdom
-
Washington University School of MedicineNational Institute of Neurological Disorders and Stroke (NINDS)RecruitingBrain Diseases | Sickle Cell Disease | Anemia, Sickle Cell | Child, OnlyUnited States
-
GlaxoSmithKlineCompleted
-
Rikshospitalet University HospitalUniversity Hospital MuensterCompleted