Home/Get Matched/NCT05433129
Recruiting
View on ClinicalTrials.gov

Testing Transient hyperemic response with Orthostatic challenge for cerebral autoregulation mapping

Official title: Non-Invasive Mapping of Cerebral Autoregulation Using Near Infrared Spectroscopy

Condition: Cerebral Autoregulation MappingSponsor: University of ManitobaTarget enrollment: 250
  • 1 group
  • One site, in Winnipeg
  • Recruiting
Health Sciences Centre (HSC), Winnipeg, Manitoba

Interventions (4)

  • Medical procedure

    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.

  • Medical procedure

    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.

  • Medical procedure

    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.

Canadian Sites (1)

1 of 1 recruiting

  • Health Sciences Centre (HSC)

    Winnipeg, Manitoba

    Recruiting

Eligibility Criteria

See who this study is looking for4 criteria

The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.

Inclusion

  • +Healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more → (male and female)

Exclusion

  • History of neurological illness
  • History of systemic vascular
  • History of cerebrovascular disease
5 concepts to explore on this page · up to 1,300 pointsTap any term to learn what it means.

In plain language

Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.

Learning 
What this study is

This study does not fall into the standard research categories.

This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.

From the trial registry

Built from these fields:

  • designModule.designInfo.primaryPurpose
  • designModule.phases
Who receives what

Everyone in this study is in one group, which receives one or more of: Transient hyperemic response, Orthostatic challenge, Vascular chemo-reactivity and Neurovascular coupling.

From the trial registry

Built from these fields:

  • armsInterventionsModule.armGroups[].label
  • armsInterventionsModule.armGroups[].type
  • armsInterventionsModule.armGroups[].interventionNames
How the study is run

There is only one group in this study, so there is no assignment to different treatments.

This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.

From the trial registry

Built from these fields:

  • designModule.designInfo.allocation
  • designModule.designInfo.maskingInfo.masking
Is there a placebo?

This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.

From the trial registry

Built from these fields:

  • armsInterventionsModule.armGroups[].type
  • armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for

The study lists a minimum age of 18 years, with no upper limit given.

The study is open to people of any sex.

The study accepts healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more → as well as people with the condition.

These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.

From the trial registry

Built from these fields:

  • eligibilityModule.minimumAge
  • eligibilityModule.sex
  • eligibilityModule.healthyVolunteers
How big and how long

The study aims to enrol about 250 people.

The study is currently expected to finish around December 2027.

The main measurement is taken over: 2 years.

From the trial registry

Built from these fields:

  • designModule.enrollmentInfo.count
  • statusModule.completionDateStruct.date
  • outcomesModule.primaryOutcomes[].timeFrame
What the study measures

In Vivo testing and optimization of device during various perturbations — measured over 2 years.

Explore impact of aging and sex on regional disparities in Cerebral Autoregulation — measured over 3 years.

From the trial registry

Built from these fields:

  • outcomesModule.primaryOutcomes[].measure
  • outcomesModule.primaryOutcomes[].timeFrame

Source: NCT05433129 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.

Not medical advice. What do these terms mean?

What is being tested — in plain terms

About Transient hyperemic responseProcedure

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.

From the trial registry — its own words, unedited.

What a procedure is here: A surgery, technique or clinical procedure being studied.

Read the full explanation → · in clinical review

About Orthostatic challengeProcedure

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.

From the trial registry — its own words, unedited.

What a procedure is here: A surgery, technique or clinical procedure being studied.

Read the full explanation → · in clinical review

About Vascular chemo-reactivityProcedure

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.

From the trial registry — its own words, unedited.

What a procedure is here: A surgery, technique or clinical procedure being studied.

Read the full explanation → · in clinical review

About Neurovascular couplingProcedure

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.

From the trial registry — its own words, unedited.

What a procedure is here: A surgery, technique or clinical procedure being studied.

Read the full explanation → · in clinical review

Common questions

Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.

Am I eligible for this trial?

Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.

What the study lists: a minimum age of 18 years.

The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.

The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.

From the trial registry
  • eligibilityModule.minimumAge
  • eligibilityModule.eligibilityCriteria
Is there a placebo?

This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.

From the trial registry
  • armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?

This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.

There is only one group in this study, so there is no assignment to different treatments.

From the trial registry
  • designModule.designInfo.maskingInfo.masking
  • designModule.designInfo.allocation
Who can join?

The study lists a minimum age of 18 years, with no upper limit given.

It is open to people of any sex.

It accepts healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more → as well as people with the condition.

Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.

From the trial registry
  • eligibilityModule.minimumAge
  • eligibilityModule.sex
  • eligibilityModule.healthyVolunteers
How long would this take?

The study's main measurement is taken over: 2 years.

The study as a whole is currently expected to finish around 2027-12-31.

How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.

From the trial registry
  • outcomesModule.primaryOutcomes[].timeFrame
  • statusModule.completionDateStruct.date
How many people are taking part?

The study aims to enrol about 250 people.

From the trial registry
  • designModule.enrollmentInfo.count
Where is this happening?

This study lists one location: Winnipeg, Manitoba, Canada.

Sites can open and close during a study, so confirm with the team before travelling.

From the trial registry
  • trial_locations

About This Trial

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.

Think this trial might be right for you?

Complete a quick intake form and we will match you with this and other relevant trials based on your medical profile.

See if this trial could fit you

This page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.