Head-dOwn Position for ischEmic Stroke With Middle Cerebral Artery (HOPES)

General Hospital of Shenyang Military Region12 enrolled

Overview

The study is designed to explore the efficacy and safety of head-down position in patients with acute ischemic stroke。

Currently, the guideline recommended re-perfusion such as intravenous thrombolysis and mechanical thrombectomy as the most effective treatment for acute ischemic stroke. However, the two methods are restricted by a strict time window, which greatly limits the number of the patients receiving treatment. The abundant studies have suggested that good collateral circulation can provide compensatory blood supply to save the ischemic penumbra and reduces the infarct volume, which improves the prognosis. How to improve collateral circulation in an efficient and safe way is a clinical challenge. Our recent experiment results of the animal and clinical experiments show that head-down position can significantly increase cerebral perfusion and improve neurological function. Clinically, head-down position is simple and easy to operate, and theoretically may increases brain perfusion and improve collateral circulation. A pilot randomized clinical trial is designed to investigate the effect of head-down position combined with routine rehabilitation in patients with ischemic stroke.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Ischemic Stroke

Interventions

head-down position treatmentOTHER

In the head-down position, the body is in the supine position with the head lowered to 30 degrees

Conventional RehabilitationOTHER

The body is in the supine position without lowered head

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. age ≥18 years 2. acute ischemic stroke within 10 - 30 days of onset 3. neurological deficit: 6≤NIHSS≤16 4. Large artery atherosclerosis stroke based on TOAST criteria 5. The responsibility vessels were the middle cerebral artery or internal carotid artery, and the degree of stenosis was more than 50%. 6. first stroke onset or past stroke without obvious neurological deficit (mRS≤1) 7. fully understand and cooperate with the doctor's instructions. 8. the availability of informed consent; Exclusion Criteria: 1. Hemorrhagic stroke or mixed stroke 2. Combining with severe organ dysfunction 3. Past hemorrhagic stroke 4. A history of stroke with severe sequelae 5. Planning revascularization in 3 months 6. Ischemic stroke due to surgical intervention 7. participating in other clinical trials within 3 months 8. Pregnant or lactating women 9. any inappropriate patients assessed by the researcher

Locations (1)

General Hospital of ShenYang Military Region

Shenyang, Liaoning, China

Outcomes

Primary Outcomes

proportion of patients with modified Rankin Score 0 to 2

Time frame: 90 days

Secondary Outcomes

proportion of patients with modified Rankin Score 0 to 1

Time frame: 90 days

The percentage of reduction in Fugl-Meyer score

Time frame: 90 days

occurrence of stroke

stroke or TIA

Time frame: 90 days

The percentage of reduction in MMSE

MMSE，Mini-mental State Examination

Time frame: 90 days

The percentage of reduction in MoCA

MoCA, Montreal Congnitive Assessment

Time frame: 90 days

Incidence of major vascular events

ischemic stroke, hemorrhagic stroke, TIA, myocardial infarction, vascular death

Time frame: 90 days

the biggest tolerance time of head-down

Time frame: 90 days

Data from ClinicalTrials.gov

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