Recruiting

Cerebral Autoregulation

Sponsor:

University of Manitoba

Code:

NCT05433129

Conditions

Cerebral Autoregulation Mapping

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Transient hyperemic response

Orthostatic challenge

Vascular chemo-reactivity

Neurovascular coupling

Study Details

Brief 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 rates at each point.

The objectives of this project are as follows:

1. 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.
2. 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.

Conditions

Cerebral Autoregulation Mapping

Study ID

NCT05433129

Start date

Jul 11, 2023

Status verified date

Dec, 2025

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Healthy volunteers (male and female)
  • Age > 17

Exclusion Criteria:

  • History of neurological illness
  • History of systemic vascular
  • History of cerebrovascular disease

Study Design

Enrollment

250 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

other: Block Testing

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.

Interventions

Transient hyperemic response

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 challenge

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-reactivity

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 coupling

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.

Primary outcome measure

  • In Vivo testing and optimization of device during various perturbations [ Time Frame: 2 years ]
  • Explore impact of aging and sex on regional disparities in Cerebral Autoregulation [ Time Frame: 3 years ]

Central Contacts and Locations

Central contacts

Frederick A Zeiler, MD PhD FRCSC

+1 (431) 335-7461Frederick.Zeiler@umanitoba.ca

Locations

Health Sciences Centre (HSC)

Recruiting

Winnipeg, Manitoba, Canada, R3A 1R9

Contacts

Frederick A Zeiler, MD PhD FRCSC

+1 (204) 775-0055Frederick.Zeiler@umanitoba.ca

More Information

Sponsor

University of Manitoba

Last update posted

Jan 6, 2026

Last verified

Dec, 2025

Keywords

  • Near Infrared Spectroscopy
  • Cerebral Mapping
  • Cerebral Autoregulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Manitoba on 2026-01-06.