Head Position on Cerebral Haemodynamics in Acute Ischemic Stroke and Controls

NCT02932540 | Completed

• 1 other identifier: 0538
• Study Type: observational
• Target: 51
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

• 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

  within 24 hours, 72 hours and 3 months of the stroke symptom onset

Secondary Outcomes (3)

• dynamic cerebral autoregulation

  within 24 hours, 72 hours and 3 months of stroke symptom onset

• Neurovascular coupling

  within 24 hours, 72 hours and 3 months of stroke symptom onset

• Carbon dioxide reactivity

  within 24 hours, 72 hours and 3 months of stroke symptom onset

Study Arms (4)

Healthy controls

healthy controls subjects who have age, sex and Blood pressure matched with the acute ischaemic stroke patient

Other: change of head position

AIS patient-transient arm

transient change of head position from lying flat (0 degree) to sitting up (30 degree)

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

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

Other: change of head position

Interventions

change of head position OTHER

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; AIS patient - persistent sitting up; AIS patient-transient arm; Healthy controls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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)

You may qualify if:

• \- 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
• 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)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of Leicester: lead

Study Sites (1)

University Hosptial of Leicester NHS Trust

Leicester, LE1 5WW, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 33137635 DERIVED

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Thompson G Robinson, MD, FRCP

  University of Leicester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2016
• First Posted: October 13, 2016
• Study Start: November 1, 2015
• Primary Completion: March 31, 2017
• Study Completion: March 31, 2017
• Last Updated: January 30, 2020

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)