Ischemic StrokeNCT02932540
Head Position on Cerebral Haemodynamics in Acute Ischemic Stroke and Controls
An observational study of Ischemic Stroke, run by University of Leicester at 1 site in United Kingdom.
Trial summary
Cerebral autoregulation is an important mechanism whereby cerebral perfusion is normally maintained at a constant level, over a relatively wide blood pressure range. It can be assessed noninvasively by the use of Trans Cranial Doppler (TCD). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- change of head position
- How many people
- 51 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2015to 31 Mar 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: 11 healthy control subjects 11 acute ischaemic stroke patient 11 acute ischaemic stroke patients in the lying flat (0 degree) head position (first 24 hours of hospital admission) 11 acute ischaemic stroke patients in the sitting up ( 30 degree) head position (first 24 hours of hospital admission)
Who may be able to join
- Informed volunteer consent, patient consent or personal consultee declaration form
- Male or female, aged 18 years or above
- Able (in the Investigator's opinion) and willing to comply with all study requirements
- Willing to allow his or her General Practitioner (GP) to be notified of participation in the study Stroke Patient-specific Inclusion Criteria
- Clinical diagnosis of ischaemic stroke within 24 hours of onset (for patients waking with a stroke, time of onset will be taken to be the time when the patient was last asymptomatic)
Who cannot join
- Male or Female, aged under 18 years
- Unable (in the Investigator's opinion) or unwilling to comply with any study requirements
- Participants who practice yoga regularly
- Female participants who are pregnant, lactating or planning pregnancy during the course of the study Stroke Patient-specific Exclusion Criteria
- Clinical diagnosis of stroke greater than 24 hours from onset
- Having had a resolved transient ischaemic attack (TIA) (i.e. neurological symptoms completely resolved upon hospital presentation)
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- Definite clinical indication to 'sitting up' (≥30⁰) head position (i.e. pneumonia, decompensated heart failure)
- Definite clinical indication to lying flat (0⁰) head position (i.e. shock, airways obstruction)
- Co-morbidity with anticipated life expectancy less than 3 months
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University Hosptial of Leicester NHS Trust
Leicester, LE1 5WW
About this study
Official title: The Effects of Head Positioning on Beat to Beat Cerebral Haemodynamics: a Comparison Between Acute Stroke Patients and Healthy Control Subjects
Cerebral autoregulation is an important mechanism whereby cerebral perfusion is normally maintained at a constant level, over a relatively wide blood pressure range. It can be assessed noninvasively by the use of Trans Cranial Doppler (TCD). This means using ultrasound probes over both sides of the head to measure changes in blood flow in one of the main brain arteries (the middle cerebral artery) in response to beat to beat changes in blood pressure dynamic cerebral autoregulation (dCA). It is established that dCA is impaired following moderate to severe stroke, acting as a key role in the development of secondary brain damage related to brain swelling and further damage related to the low blood flow. The administration of clot busting therapy (thrombolysis), one of the main approved treatments of acute ischaemic stroke (AIS), results in recanalisation of the blocked artery in only approximately 50% of patients. Therefore, as well as attempts to treat major vessel blockage, improving brain blood flow, particularly to the penumbral area, through arteries that bypass the blockage is another potential therapeutic approach in AIS.One simple way of achieving this might be to lower the head of AIS patient into a lying flat (0⁰) position. However, to date, there have been very few studies exploring this. This research will use the noninvasive technique of Trans Cranial Doppler (TCD) to see how blood flow changes in different head positions, both in healthy volunteers and AIS patient. This study will provide important data regarding blood pressure management in acute stroke, an important and common clinical dilemma.
Read the detailed description
In the United Kingdom (UK) alone, approximate 100,000 people suffer a stroke each year. Improved management of stroke patients not only reduces morbidity and mortality, but also reduces the cost of long term social care.
The brain has control systems (i.e.cerebral autoregulation) to maintain blood flow to the brain, over a relatively wide blood pressure range. Cerebral Autoregulation can be described as static, reflecting the integrity of such mechanisms over time, or dynamic, occurring in response to sudden fluctuations in perfusion pressure. When blood pressure drops, small arteries increase in size to restore flow levels, and when blood pressure rises, they narrow to protect the most delicate blood vessels. It is known that sudden decompensated blood pressure (BP) changes can occur after stroke, this could result in brain bleeding and swelling when there is uncontrolled increased blood flow, or reduce the viability of tissue surrounding the stroke area when there is reduced blood flow to the brain.
It is known that the clot busting agent (Alteplase), the main effective treatment used in the acute stroke can only improve blood flow in already blocked arteries in 50% of patients. Therefore, as well as attempts to treat blockage of major vessel, improving the blood flow through vessel that bypass the blocked vessel around the stroke area (penumbra) could be another potential therapeutic approach in acute ischaemic stroke patients. A simple way of increase blood flow to these penumbral area might be just lower the head of acute stroke patients into a lying flat position. Several observational studies have investigated the effects of head positioning on blood flow to the brain in a healthy population, however few studies carried out on acute ischaemic stroke patients so far.
Cerebral autoregulation can be assessed non-invasively by the use of Trans Cranial Doppler (TCD). This means using ultrasound probes over both sides of the head to measure changes in blood flow in one of the main brain arteries (the middle cerebral artery) in response to beat to beat changes in blood pressure dynamic cerebral autoregulation. This research will use the noninvasive technique of Trans Cranial Doppler to see how blood flow changes during different head position between acute ischaemic stroke patients and healthy controls, as well as over time during recovery after a stroke. This knowledge will help us to understand the changes in brain blood flow control and blood pressure in stroke patients, with implications of diagnosis, prognosis, and treatment of the disease.
- Conditions
- Ischemic Stroke
- Being tested
- change of head position
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
change of head positionOther
patient can be allocated to the transient change of the head position, persistent lying flat position in the first 24 hours of the hospital admission and persistent sitting up in the first 24 hours of the hospital admission
| Study group | Role | What they receive |
|---|---|---|
| Healthy controls | healthy controls subjects who have age, sex and Blood pressure matched with the acute ischaemic stroke patient Receives: Other: change of head position | |
| AIS patient-transient arm | transient change of head position from lying flat (0 degree) to sitting up (30 degree) Receives: Other: change of head position | |
| AIS patient - persistent lying flat | lying flat (0 degree) head position for the first 24 hours in the hospital admission Receives: Other: change of head position | |
| AIS patient - persistent sitting up | sitting up ( 30 degree) head position for the first 24 hours in the hospital admission Receives: Other: change of head position |
What is being measured
The primary outcome is the main question the study is designed to answer.
cerebral blood flow velocity
percentage change of the cerebral blood flow velocity in response to change of the head position within 24 hours, 72 hours and 3 months of the stroke symptom onset
Measured: within 24 hours, 72 hours and 3 months of the stroke symptom onset
Secondary outcomes (3)
dynamic cerebral autoregulation
change of dynamic cerebral autoregulation within 24 hours, 72 hours and 3 months of the stroke symptom onset.
Measured: within 24 hours, 72 hours and 3 months of stroke symptom onset
Neurovascular coupling
change of neurovascular coupling within 24 hours, 72 hours and 3 months of stroke symptom onset
Measured: within 24 hours, 72 hours and 3 months of stroke symptom onset
Carbon dioxide reactivity
change of carbon dioxide reactivity within 24 hours, 72 hours and 3 month of stroke symptom onset.
Measured: within 24 hours, 72 hours and 3 months of stroke symptom onset
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2016 (estimated)
- Study startNov 2015
- Primary completion31 Mar 2017
- Study completion31 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leicester
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thompson G Robinson, MD, FRCP, Principal investigator, University of Leicester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02932540
- Sponsor's protocol ID
- 0538
- Status last verified
- May 2016
- First submitted
- 6 Oct 2016
- Last updated
- 30 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Lam MY, Haunton VJ, Nath M, Panerai RB, Robinson TG. The effect of head positioning on cerebral hemodynamics: Experiences in mild ischemic stroke. J Neurol Sci. 2020 Dec 15;419:117201. doi: 10.1016/j.jns.2020.117201. Epub 2020 Oct 21.
PubMed 33137635
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Head Positioning on Beat to Beat Cerebral Haemodynamics: a Comparison Between Acute Stroke Patients and Healthy Control Subjects
- ClinicalTrials.gov ID
- NCT02932540
- Acronym / sponsor ID
- 0538
- Conditions
- Ischemic Stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University of LeicesterUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- 31 Mar 2017 (actual)
- Study completion
- 31 Mar 2017 (actual)
- First posted
- 13 Oct 2016 (estimated)
- 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.
Cerebral autoregulation is an important mechanism whereby cerebral perfusion is normally maintained at a constant level, over a relatively wide blood pressure range. It can be assessed noninvasively by the use of Trans Cranial Doppler (TCD). This means using ultrasound probes over both sides of the head to measure changes in blood flow in one of the main brain arteries (the middle cerebral artery) in response to beat to beat changes in blood pressure dynamic cerebral autoregulation (dCA). It is established that dCA is impaired following moderate to severe stroke, acting as a key role in the development of secondary brain damage related to brain swelling and further damage related to the low blood flow. The administration of clot busting therapy (thrombolysis), one of the main approved treatments of acute ischaemic stroke (AIS), results in recanalisation of the blocked artery in only approximately 50% of patients. Therefore, as well as attempts to treat major vessel blockage, improving brain blood flow, particularly to the penumbral area, through arteries that bypass the blockage is another potential therapeutic approach in AIS.One simple way of achieving this might be to lower the head of AIS patient into a lying flat (0⁰) position. However, to date, there have been very few studies exploring this. This research will use the noninvasive technique of Trans Cranial Doppler (TCD) to see how blood flow changes in different head positions, both in healthy volunteers and AIS patient. This study will provide important data regarding blood pressure management in acute stroke, an important and common clinical dilemma.
Detailed description
In the United Kingdom (UK) alone, approximate 100,000 people suffer a stroke each year. Improved management of stroke patients not only reduces morbidity and mortality, but also reduces the cost of long term social care.
The brain has control systems (i.e.cerebral autoregulation) to maintain blood flow to the brain, over a relatively wide blood pressure range. Cerebral Autoregulation can be described as static, reflecting the integrity of such mechanisms over time, or dynamic, occurring in response to sudden fluctuations in perfusion pressure. When blood pressure drops, small arteries increase in size to restore flow levels, and when blood pressure rises, they narrow to protect the most delicate blood vessels. It is known that sudden decompensated blood pressure (BP) changes can occur after stroke, this could result in brain bleeding and swelling when there is uncontrolled increased blood flow, or reduce the viability of tissue surrounding the stroke area when there is reduced blood flow to the brain.
It is known that the clot busting agent (Alteplase), the main effective treatment used in the acute stroke can only improve blood flow in already blocked arteries in 50% of patients. Therefore, as well as attempts to treat blockage of major vessel, improving the blood flow through vessel that bypass the blocked vessel around the stroke area (penumbra) could be another potential therapeutic approach in acute ischaemic stroke patients. A simple way of increase blood flow to these penumbral area might be just lower the head of acute stroke patients into a lying flat position. Several observational studies have investigated the effects of head positioning on blood flow to the brain in a healthy population, however few studies carried out on acute ischaemic stroke patients so far.
Cerebral autoregulation can be assessed non-invasively by the use of Trans Cranial Doppler (TCD). This means using ultrasound probes over both sides of the head to measure changes in blood flow in one of the main brain arteries (the middle cerebral artery) in response to beat to beat changes in blood pressure dynamic cerebral autoregulation. This research will use the noninvasive technique of Trans Cranial Doppler to see how blood flow changes during different head position between acute ischaemic stroke patients and healthy controls, as well as over time during recovery after a stroke. This knowledge will help us to understand the changes in brain blood flow control and blood pressure in stroke patients, with implications of diagnosis, prognosis, and treatment of the disease.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Healthy controls | – | Other: change of head positionhealthy controls subjects who have age, sex and Blood pressure matched with the acute ischaemic stroke patient |
| AIS patient-transient arm | – | Other: change of head positiontransient change of head position from lying flat (0 degree) to sitting up (30 degree) |
| AIS patient - persistent lying flat | – | Other: change of head positionlying flat (0 degree) head position for the first 24 hours in the hospital admission |
| AIS patient - persistent sitting up | – | Other: change of head positionsitting up ( 30 degree) head position for the first 24 hours in the hospital admission |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 11 healthy control subjects 11 acute ischaemic stroke patient 11 acute ischaemic stroke patients in the lying flat (0 degree) head position (first 24 hours of hospital admission) 11 acute ischaemic stroke patients in the sitting up ( 30 degree) head position (first 24 hours of hospital admission)
Key inclusion criteria (5 listed)
- Informed volunteer consent, patient consent or personal consultee declaration form
- Male or female, aged 18 years or above
- Able (in the Investigator's opinion) and willing to comply with all study requirements
- Willing to allow his or her General Practitioner (GP) to be notified of participation in the study Stroke Patient-specific Inclusion Criteria
- Clinical diagnosis of ischaemic stroke within 24 hours of onset (for patients waking with a stroke, time of onset will be taken to be the time when the patient was last asymptomatic)
Key exclusion criteria (9 listed)
- Male or Female, aged under 18 years
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 |
|---|---|---|
| change of head positionpatient can be allocated to the transient change of the head position, persistent lying flat position in the first 24 hours of the hospital admission and persistent sitting up in the first 24 hours of the hospital admission | Other | AIS patient - persistent lying flat, AIS patient - persistent sitting up, AIS patient-transient arm, Healthy controls |
Primary outcome
cerebral blood flow velocity
Time frame: within 24 hours, 72 hours and 3 months of the stroke symptom onset
percentage change of the cerebral blood flow velocity in response to change of the head position within 24 hours, 72 hours and 3 months of the stroke symptom onset
3 secondary outcomes
dynamic cerebral autoregulation
Time frame: within 24 hours, 72 hours and 3 months of stroke symptom onset
Neurovascular coupling
Time frame: within 24 hours, 72 hours and 3 months of stroke symptom onset
Carbon dioxide reactivity
Time frame: within 24 hours, 72 hours and 3 months of stroke symptom onset
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2020.
- Derived from this study: PubMed 33137635Lam MY, Haunton VJ, Nath M, Panerai RB, Robinson TG. The effect of head positioning on cerebral hemodynamics: Experiences in mild ischemic stroke. J Neurol Sci. 2020 Dec 15;419:117201. doi: 10.1016/j.jns.2020.117201. Epub 2020 Oct 21.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Thompson G Robinson, MD, FRCP principal investigator
University of Leicester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Stroke, run by University of Leicester at 1 site in United Kingdom.
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 5 inclusion and 9 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: finished, as of the sponsor's last update on 30 Jan 2020. 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 United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cerebral blood flow velocity (time frame: within 24 hours, 72 hours and 3 months of the stroke symptom onset). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02932540, which also lists 1 linked publication.
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 30 Jan 2020.