Using head-down position for treating acute ischemic stroke

Trendelenburg Position for Acute Anterior Circulation Ischemic Stroke With Large Artery Atherosclerosis Etiology (HOPES 3): a Prospective, Randomized, Open-label, Blinded-endpoint, Multi-center Trial

This study is testing if lying in a head-down position can help adults with acute ischemic stroke caused by large artery blockages recover better.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 600 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: General Hospital of Shenyang Military Region (other)
• Locations: 1 site (Shenyang)
• Trial ID: NCT06010641 on ClinicalTrials.gov

What this trial studies

This study investigates the efficacy and safety of the head-down position (HDP) as a nonpharmacological therapy for patients with acute ischemic stroke caused by large artery atherosclerosis. It aims to determine whether this positioning can improve outcomes for patients with moderate neurologic deficits. The study will include adults who meet specific criteria related to stroke severity and etiology, and will assess the impact of HDP within a defined time frame after stroke onset.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with acute ischemic stroke and moderate neurologic deficits due to large artery atherosclerosis.

Not a fit: Patients with pre-stroke disabilities, consciousness disturbances, or those who have undergone thrombolysis or thrombectomy may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a simple and effective treatment option for improving recovery in acute ischemic stroke patients.

How similar studies have performed: Previous studies, such as HOPES2, have suggested potential benefits of the head-down position in similar patient populations, indicating a promising avenue for further investigation.

Eligibility criteria

Inclusion Criteria:

* Age ≥ 18 years old
* Acute ischemic stroke confirmed by NCCT or MRI;
* Moderate neurologic deficit (6≤ NIHSS ≤ 16) within 24 hours of onset, or progressing from mild (NIHSS ≤ 5) to moderate neurologic deficit (6≤ NIHSS ≤ 16) within 24 hours, requiring ≥ 4 point increase in NIHSS score although the onset time is beyond 24 hours;
* Probable large artery atherosclerosis etiology based on the Trial of Org 10172 in Acute Stroke Treatment (TOAST) criteria (responsible artery stenosis ≥ 50% or occlusion);
* Anterior circulation stroke (internal carotid artery, M1 or M2 of middle cerebral artery);
* First stroke onset or past stroke without obvious neurological deficit (mRS≤2);
* Signed informed consent.

Exclusion Criteria:

* Pre-stroke disability (mRS≥3);
* Patients with disturbance of consciousness;
* Patients who plan to undergo or have completed thrombolysis or mechanical thrombectomy;
* Hemorrhagic stroke or combined ischemic and hemorrhagic stroke;
* Serious comorbidity, such as liver or kidney insufficiency, malignant tumor, etc;
* Other stroke etiologies, such as cardiogenic embolism, arteritis, arterial dissection, moyamoya disease, etc;
* Previous history of intracerebral hemorrhage within 1 year;
* Any contraindication to head-down position (e.g. active vomiting, pneumonia, uncontrolled heart failure);
* Planned carotid or intracranial revascularization within 3 months;
* Severe uncontrolled hypertension (systolic blood pressure over 180mmHg or diastolic blood pressure over 100 mmHg);
* Cardiac insufficiency (NYHA Class ≥II);
* Pregnant or lactating women;
* Comorbidity with other serious diseases;
* Participating in other clinical trials within 3 months;
* Patients not suitable for the study considered by researcher.

Where this trial is running

Shenyang

• Department of Neurology, General Hospital of Northern Theater Command — Shenyang, China (RECRUITING)

Conditions: Stroke, Acute Ischemic