Head Position on Cerebral Haemodynamics in Acute Ischemic Stroke and Controls
NCT ID: NCT02932540
Last Updated: 2020-01-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
51 participants
OBSERVATIONAL
2015-11-30
2017-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The Relationship Between Controlling Risk Factors and Cerebral Haemodynamics in Lacunar Stroke
NCT06354881
Cerebral Haemodynamics in Stroke Thrombolysis Study (CHIST)
NCT02928926
Head Position After Endovascular Therapy
NCT06115707
Impact of Verticalization on Intracranial Hemodynamics Assessed in Transcranial Doppler at the Acute Phase of Cerebral Infarction
NCT03985059
Ischaemic Lesions in Acute Intracerebral Haemorrhage
NCT06410274
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Healthy controls
healthy controls subjects who have age, sex and Blood pressure matched with the acute ischaemic stroke patient
change of head position
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
AIS patient-transient arm
transient change of head position from lying flat (0 degree) to sitting up (30 degree)
change of head position
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
AIS patient - persistent lying flat
lying flat (0 degree) head position for the first 24 hours in the hospital admission
change of head position
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
AIS patient - persistent sitting up
sitting up ( 30 degree) head position for the first 24 hours in the hospital admission
change of head position
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
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
change of head position
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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Male or female, aged 18 years or above
* Able (in the Investigator's opinion) and willing to comply with all study requirements
* 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)
Exclusion Criteria
* Unable (in the Investigator's opinion) or unwilling to comply with any study requirements
* Participants who practice yoga regularly
* 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)
* 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
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Leicester
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Thompson G Robinson, MD, FRCP
Role: PRINCIPAL_INVESTIGATOR
University of Leicester
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University Hosptial of Leicester NHS Trust
Leicester, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
0538
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.