Cerebral Autoregulation MappingNCT05433129
Non-Invasive Mapping of Cerebral Autoregulation Using Near Infrared Spectroscopy
A study testing Transient hyperemic response, Orthostatic challenge and Vascular chemo-reactivity in people with Cerebral Autoregulation Mapping, run by University of Manitoba at 1 site in Canada.
Trial summary
The investigators propose to employ advanced multi-channel near non-invasive near infrared spectroscopy (NIRS) system married with entirely non-invasive continuous arterial blood pressure (niABP) monitor to create a new wearable and portable imaging system that derives CA maps of the entire brain with high sampling… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cerebral Autoregulation Mapping
- What is being tested?
- Transient hyperemic response, Orthostatic challenge and Vascular chemo-reactivity
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteCanada
- Study dates
- 11 Jul 2023to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers (male and female)
- Age > 17
Who cannot join
- History of neurological illness
- History of systemic vascular
- History of cerebrovascular disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Health Sciences Centre (HSC)
Winnipeg, Manitoba, R3A 1R9
Frederick A Zeiler, MD PhD FRCSC, +1 (204) 775-0055, Frederick.Zeiler@umanitoba.ca
About this study
The investigators propose to employ advanced multi-channel near non-invasive near infrared spectroscopy (NIRS) system married with entirely non-invasive continuous arterial blood pressure (niABP) monitor to create a new wearable and portable imaging system that derives CA maps of the entire brain with high sampling rates at each point.
The objectives of this project are as follows:
- To perform in vivo testing and optimization of the device using a block-trial design to evaluate the CA mapping system's performance during various perturbations.
- To explore the impact of aging and sex on regional disparities in CA in a healthy volunteer population using static recording along with perturbation testing.
Read the detailed description
Objective 1:
To assess functionality and feasibility of real-time application in humans, in vivo testing will occur on a small population (n=50) of healthy human volunteers. Such work will investigate feasibility of the combination monitoring setup, optimal NIRS channel placement using the adjustable OxyMon NIRS cap, ability for pipelines to extract and analyze signals in real time for continuous derivation of NIRS-based CVR metrics at each channel and functionality of CVR map generation in real-time. Finally, the investigators will investigate perturbations to system through a series of testing (block design separated by baseline rest): A. transient hyperemic response testing via carotid compression methods, B. orthostatic challenge responses (lying-to-sit, sit-to-stand), C. vascular chemo-reactivity via fast and slow breathing exercises and D. impact of neurovascular coupling through cognitive/Stroop testing. Work here will establish areas for improvement in real time. The testing and optimization phase will last 18 months. The addition of single rSO2 channel from commercial NIRS will be used to provide a "gold standard" data stream to compare our results to.
Objective 2:
Current understanding of the aging process and sex on continuously assessed CA, and regional disparities, has been hampered by a lack of high-resolution platform. The investigators will evaluate the impact of both age and sex on CA using the newly developed platform through static CA assessments in 200 healthy volunteers. Within the 1-hour period, volunteers will have their age and sex recorded in a de-identified electronic database, have an hour of non-invasive simultaneous 24 Channel OxyMon NIRS , Finapres NOVA ABP, and single channel commercial NIRS rSO2 recording which is divided into static resting state recording and perturbation testing. This will facilitate the derivation of a normative reference range for CA using the platform along with making the dataset richer. Static resting state assessments will be done over the first half hour and in second half hour, perturbations to system will be investigated through a series of testing separated by baseline rest: A. orthostatic challenge responses (lying-to-sit, sit-to-stand), B. vascular chemo-reactivity via fast and slow breathing exercises and C. impact of neurovascular coupling through Stroop testing. The addition of single rSO2 channel from commercial NIRS will be used to provide a "gold standard" data stream to compare our results to.
- Conditions
- Cerebral Autoregulation Mapping
- Being tested
- Transient hyperemic response, Orthostatic challenge, Vascular chemo-reactivity, Neurovascular coupling
- Keywords
- Near Infrared Spectroscopy, Cerebral Mapping, Cerebral Autoregulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transient hyperemic responseProcedure or surgery
The transient hyperemic response will be tested via carotid compression method. This test will consist of 5 carotid compressions lasting 5 seconds each with a 60 seconds interval between each compression to allow normalization of the CBF to precompression levels, and the total time for this block would be 6 minutes. The ipsilateral common carotid artery will be compressed for this method, and the response of the middle cerebral artery (MCA) blood flow velocity will be assessed using transcranial doppler (TCD) probe (EMS-9D, Delica). The carotid compressions will only be accepted when there is no further decrease in blood flow velocity can be achieved and stable conditions remained during the whole period of the compression. Otherwise, the compression will be terminated and repeated again after 60 seconds. Satisfactory compression is typically considered to result in a reduction in MCA velocity of 50%, at a minimum.
Orthostatic challengeProcedure or surgery
The orthostatic challenge response will be evaluated by lying-to-sit and sit-to-stand methods 5 times where sitting and standing positions will be held for 3 minutes each for a total block time of 35 minutes. A baseline in lying position will be collected at the start of the block, then the position will be changed from lying to sit for 3 minutes and then position will be changed to standing for another 3 minutes.
Vascular chemo-reactivityProcedure or surgery
vascular chemo-reactivity will be assessed by varying CO2 concentrations through slow and fast breathing exercises with Capnostream 35 Portable Respiratory Monitor (Medtronic Canada) to monitor EtCO2 through nose clip. The breathing trials will occur two times and each of them will have fast and slow trials along with an interval of normal breathing. First time, the normal, fast and slow breathing trials will be 2.5 minutes long while the second time, these breathing trials will be 1.5 minutes long. The normal respiratory rate for adults is 12 breaths/minute, the target slow respiratory rate will be 5 breaths/minute and fast respiratory rate will be 25 breaths/minute as set by metronome. It has been shown that the EtCO2 has a 10% increase during hypoventilation and almost 50% decrease during hyperventilation compared to normal breathing.
Neurovascular couplingProcedure or surgery
The fourth block will evaluate the neurovascular coupling using Automated Neuropsychological Assessment Metrics (ANAM) General Neuropsychological Screening (GNS) Clinical Toolkit which contains 5 tests explained as follows 1) Standard Continuous Performance test will assess sustained attention, concentration and working memory. 2) Manikin test will assess 3D spatial rotation ability, left-right orientation, problem solving and attention. 3) Pursuit Tracking test will measure the visuo-motor control. 4) Switching test will assess divided attention, mental flexibility, and executive function. 5) Stroop test will assess the processing speed, selective attention, interference, and executive functioning with three trial blocks.
| Study group | Role | What they receive |
|---|---|---|
| Block Testing | Other | Perturbations to the system will be investigated through a series of testing (block design separated by baseline rest): A. transient hyperemic response testing via carotid compression methods, B. orthostatic challenge responses (lying-to-sit, sit-to-stand),8 C. vascular chemo-reactivity via fast and slow breathing exercises and D. impact of neurovascular coupling through cognitive/Stroop testing. Work here will establish areas for improvement in real time. Receives: Procedure: Transient hyperemic response; Procedure: Orthostatic challenge; Procedure: Vascular chemo-reactivity; Procedure: Neurovascular coupling |
What is being measured
The primary outcome is the main question the study is designed to answer.
In Vivo testing and optimization of device during various perturbations
To assess functionality and feasibility of real-time application in humans, in vivo testing will occur on a small population of healthy human volunteers. Such work will investigate feasibility of the combination monitoring setup, optimal NIRS channel placement using the adjustable OxyMon NIRS cap, ability for pipelines to extract, and analyze signals in real time for continuous derivation of NIRS-based CVR metrics at each channel and functionality of CVR map generation in real-time.
Measured: 2 years
Explore impact of aging and sex on regional disparities in Cerebral Autoregulation
Current understanding of the aging process and sex on continuously assessed CA, and regional disparities, has been hampered by a lack of high-resolution platform. We will evaluate the impact of both age, and sex on CA using the newly developed platform through static CA assessments in healthy volunteers.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2022
- Study start11 Jul 2023
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Autoregulation MappingStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Device optimization and assessment
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- Health Sciences Centre, Winnipeg, Manitoba, Natural Sciences and Engineering Research Council, Canada
- Responsible party
- Sponsor
- Investigators
- Frederick A Zeiler, MD PhD FRCSC, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05433129
- Sponsor's protocol ID
- HS25527 (B2022:051)
- Other IDs
- RGPIN-2022-03621
- Status last verified
- Dec 2025
- First submitted
- 10 Jun 2022
- Last updated
- 6 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Invasive Mapping of Cerebral Autoregulation Using Near Infrared Spectroscopy
- ClinicalTrials.gov ID
- NCT05433129
- Acronym / sponsor ID
- HS25527 (B2022:051)
- Conditions
- Cerebral Autoregulation Mapping
- Keywords
- Near Infrared Spectroscopy, Cerebral Mapping, Cerebral Autoregulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- Health Sciences Centre, Winnipeg, Manitoba, Natural Sciences and Engineering Research Council, Canada
- Study start
- 11 Jul 2023 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 27 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators propose to employ advanced multi-channel near non-invasive near infrared spectroscopy (NIRS) system married with entirely non-invasive continuous arterial blood pressure (niABP) monitor to create a new wearable and portable imaging system that derives CA maps of the entire brain with high sampling rates at each point.
The objectives of this project are as follows:
- To perform in vivo testing and optimization of the device using a block-trial design to evaluate the CA mapping system's performance during various perturbations.
- To explore the impact of aging and sex on regional disparities in CA in a healthy volunteer population using static recording along with perturbation testing.
Detailed description
Objective 1:
To assess functionality and feasibility of real-time application in humans, in vivo testing will occur on a small population (n=50) of healthy human volunteers. Such work will investigate feasibility of the combination monitoring setup, optimal NIRS channel placement using the adjustable OxyMon NIRS cap, ability for pipelines to extract and analyze signals in real time for continuous derivation of NIRS-based CVR metrics at each channel and functionality of CVR map generation in real-time. Finally, the investigators will investigate perturbations to system through a series of testing (block design separated by baseline rest): A. transient hyperemic response testing via carotid compression methods, B. orthostatic challenge responses (lying-to-sit, sit-to-stand), C. vascular chemo-reactivity via fast and slow breathing exercises and D. impact of neurovascular coupling through cognitive/Stroop testing. Work here will establish areas for improvement in real time. The testing and optimization phase will last 18 months. The addition of single rSO2 channel from commercial NIRS will be used to provide a "gold standard" data stream to compare our results to.
Objective 2:
Current understanding of the aging process and sex on continuously assessed CA, and regional disparities, has been hampered by a lack of high-resolution platform. The investigators will evaluate the impact of both age and sex on CA using the newly developed platform through static CA assessments in 200 healthy volunteers. Within the 1-hour period, volunteers will have their age and sex recorded in a de-identified electronic database, have an hour of non-invasive simultaneous 24 Channel OxyMon NIRS , Finapres NOVA ABP, and single channel commercial NIRS rSO2 recording which is divided into static resting state recording and perturbation testing. This will facilitate the derivation of a normative reference range for CA using the platform along with making the dataset richer. Static resting state assessments will be done over the first half hour and in second half hour, perturbations to system will be investigated through a series of testing separated by baseline rest: A. orthostatic challenge responses (lying-to-sit, sit-to-stand), B. vascular chemo-reactivity via fast and slow breathing exercises and C. impact of neurovascular coupling through Stroop testing. The addition of single rSO2 channel from commercial NIRS will be used to provide a "gold standard" data stream to compare our results to.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Device optimization and assessment
| Arm | Type | Receives |
|---|---|---|
| Block Testing | Other | Procedure: Transient hyperemic response, Procedure: Orthostatic challenge, Procedure: Vascular chemo-reactivity, Procedure: Neurovascular couplingPerturbations to the system will be investigated through a series of testing (block design separated by baseline rest): A. transient hyperemic response testing via carotid compression methods, B. orthostatic challenge responses (lying-to-sit, sit-to-stand),8 C. vascular chemo-reactivity via fast and slow breathing exercises and D. impact of neurovascular coupling through cognitive/Stroop testing. Work here will establish areas for improvement in real time. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy volunteers (male and female)
- Age > 17
Key exclusion criteria (3 listed)
- History of neurological illness
- History of systemic vascular
- History of cerebrovascular disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transient hyperemic responseThe transient hyperemic response will be tested via carotid compression method. This test will consist of 5 carotid compressions lasting 5 seconds each with a 60 seconds interval between each compression to allow normalization of the CBF to precompression levels, and the total time for this block would be 6 minutes. The ipsilateral common carotid artery will be compressed for this method, and the response of the middle cerebral artery (MCA) blood flow velocity will be assessed using transcranial doppler (TCD) probe (EMS-9D, Delica). The carotid compressions will only be accepted when there is no further decrease in blood flow velocity can be achieved and stable conditions remained during the whole period of the compression. Otherwise, the compression will be terminated and repeated again after 60 seconds. Satisfactory compression is typically considered to result in a reduction in MCA velocity of 50%, at a minimum. | Procedure or surgery | Block Testing |
| Orthostatic challengeThe orthostatic challenge response will be evaluated by lying-to-sit and sit-to-stand methods 5 times where sitting and standing positions will be held for 3 minutes each for a total block time of 35 minutes. A baseline in lying position will be collected at the start of the block, then the position will be changed from lying to sit for 3 minutes and then position will be changed to standing for another 3 minutes. | Procedure or surgery | Block Testing |
| Vascular chemo-reactivityvascular chemo-reactivity will be assessed by varying CO2 concentrations through slow and fast breathing exercises with Capnostream 35 Portable Respiratory Monitor (Medtronic Canada) to monitor EtCO2 through nose clip. The breathing trials will occur two times and each of them will have fast and slow trials along with an interval of normal breathing. First time, the normal, fast and slow breathing trials will be 2.5 minutes long while the second time, these breathing trials will be 1.5 minutes long. The normal respiratory rate for adults is 12 breaths/minute, the target slow respiratory rate will be 5 breaths/minute and fast respiratory rate will be 25 breaths/minute as set by metronome. It has been shown that the EtCO2 has a 10% increase during hypoventilation and almost 50% decrease during hyperventilation compared to normal breathing. | Procedure or surgery | Block Testing |
| Neurovascular couplingThe fourth block will evaluate the neurovascular coupling using Automated Neuropsychological Assessment Metrics (ANAM) General Neuropsychological Screening (GNS) Clinical Toolkit which contains 5 tests explained as follows 1) Standard Continuous Performance test will assess sustained attention, concentration and working memory. 2) Manikin test will assess 3D spatial rotation ability, left-right orientation, problem solving and attention. 3) Pursuit Tracking test will measure the visuo-motor control. 4) Switching test will assess divided attention, mental flexibility, and executive function. 5) Stroop test will assess the processing speed, selective attention, interference, and executive functioning with three trial blocks. | Procedure or surgery | Block Testing |
Primary outcome
In Vivo testing and optimization of device during various perturbations
Time frame: 2 years
To assess functionality and feasibility of real-time application in humans, in vivo testing will occur on a small population of healthy human volunteers. Such work will investigate feasibility of the combination monitoring setup, optimal NIRS channel placement using the adjustable OxyMon NIRS cap, ability for pipelines to extract, and analyze signals in real time for continuous derivation of NIRS-based CVR metrics at each channel and functionality of CVR map generation in real-time.
Explore impact of aging and sex on regional disparities in Cerebral Autoregulation
Time frame: 3 years
Current understanding of the aging process and sex on continuously assessed CA, and regional disparities, has been hampered by a lack of high-resolution platform. We will evaluate the impact of both age, and sex on CA using the newly developed platform through static CA assessments in healthy volunteers.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Frederick A Zeiler, MD PhD FRCSC principal investigator
University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transient hyperemic response, Orthostatic challenge and Vascular chemo-reactivity in people with Cerebral Autoregulation Mapping, run by University of Manitoba at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Frederick A Zeiler, MD PhD FRCSC (+1 (431) 335-7461, Frederick.Zeiler@umanitoba.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In Vivo testing and optimization of device during various perturbations (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2026.