Clinical trial NCT04848285: Cerebral Blood Flow-guided Early Rehabilitation Intervention After Stroke: a Pilot Randomized Trial (STAND-OP)
Official title: Cerebral Blood Flow-guided Early Rehabilitation Intervention After Stroke: a Pilot Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Stroke
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
Collaborators: name: Fundació La Marató de TV3
First posted: 2021-04-19
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary goal of most acute stroke interventions is to restore cerebral blood flow (CBF) in the affected region and prevent hypoperfusion during early clinical course. Diffuse optical technology offers a new opportunity for invasive, real time and bedside assessment of brain function biomarkers, including CBF. However, whether CBF monitoring can identify patients who are most likely to benefit from therapies is unclear Recently, it was suggested that the benefit of early mobilization (EM) after stroke on motor recovery may be outweighed by a deleterious effect on cerebral perfusion if cerebral autoregulation (CA) is impaired. Hypothetically, EM could improve recovery outcomes after stroke in selected patients based on CA function. Our objective is to investigate if EM leads to superior motor and functional outcome after stroke compared to standard care (SC) in selected patients based on optical biomarkers of CA and evaluate the feasibility of the clinical use of a novel transcranial optical monitoring system adapted to deliver biomarkers of CA at the bedside. The investigators designed a randomized controlled, open-labeled trial with blinded assessment of outcome end-points in a stroke unit of a tertiary stroke center. Patients with an ischemic or hemorrhagic stroke will be recruited and randomly assigned within 24 hours after symptoms onset to receive SC alone or EM in addition to SC. All patients will undergo optical monitoring of CA on admission to the Stroke Unit during the first mobilization. Randomization will be stratified by stroke severity and type of stroke. Clinical outcome will be assessed with the Postural Assessment Scale for Stroke (PASS) and modified Rankin scale at 90 days. Safety outcome will be assessed by recording the incidence of neurological deterioration, recurrence and falls.

Detailed description: Background: The primary goal of most acute stroke interventions is to restore cerebral blood flow (CBF) in the affected region and prevent hypoperfusion during early clinical course. Diffuse optical technology offers a new opportunity for invasive, real time and bedside assessment of brain function biomarkers, including CBF.

However, whether CBF monitoring can identify patients who are most likely to benefit from therapies is unclear. The results of AVERT trial suggested that the benefit of early mobilization (EM) after stroke on functional outcome may be outweighed by a hypothetical deleterious effect on cerebral perfusion if cerebral autoregulation (CA) is impaired. EM could improve recovery outcomes after stroke in selected patients based on the status of CA function.

Objectives: 1) to investigate if EM leads to superior motor and functional outcome after stroke compared to standard care (SC) in selected patients based on optical biomarkers of CA. 2) To evaluate the feasibility of the clinical use of a novel transcranial optical monitoring system adapted to deliver biomarkers of CA at the bedside.

Methodology: A randomized controlled, open-labeled trial with blinded assessment of outcome end-points in a stroke unit of a tertiary stroke center. Patients with an ischemic or hemorrhagic stroke will be randomly assigned within 24 hours after symptoms onset to receive SC alone or EM in addition to SC. All patients will undergo optical monitoring of CA on admission to the Stroke Unit. Randomization will be stratified according to stroke severity measured with the National institute of Health Stroke Scale (NIHSS) and type of stroke (ischemic or hemorrhagic). Clinical outcome will be assessed with the Postural Assessment Scale for Stroke (PASS) and modified Rankin scale at 90 days. Safety outcome will be assessed by recording the incidence of neurological deterioration, recurrence and falls.

Expected results: to provide a new in vivo biomarker of cerebrovascular function for more accurate and earlier prediction of response to therapy, leading to improved clinical decisions and outcomes.

Eligibility criteria: Inclusion Criteria:

* Patients 18 years or over, with a clinical diagnosis of first or recurrent stroke, either ischemic or hemorrhagic.
* Recruitment within 24 hours of onset of stroke symptoms.
* Admission to the stroke unit
* Informed consent obtained from the patient or responsible third party

Exclusion Criteria:

* Pre-stroke modified Rankin scale score \>3
* Transient ischemic attacks
* Exclusively retinal stroke
* Deterioration in patient´s neurological condition in the first hours of admission resulting in urgent surgery, admission to ICU or a documented decision for palliative care.
* Unstable medical condition
* A suspected or confirmed lower limb fracture at the time of stroke preventing the implementation of the mobilization protocol.

Primary outcomes:
measure: Postural Assessment Scale for Stroke
timeFrame: 90 days
Secondary outcomes:
measure: Health-related quality of life
timeFrame: Discharge and 90 days
measure: Modified Rankin scale
timeFrame: 90 days
measure: Neurological deterioration measured with the NIHSS
timeFrame: 14 days
measure: Recurrent Stroke
timeFrame: 90 days
measure: Falls after stroke
timeFrame: 90 days
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Santa Creu i Sant Pau
Study officials:
affiliation: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
name: Raquel Delgado-Mederos, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: