Using head-down position for treating acute ischemic stroke

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Department of Neurology, General Hospital of Northern Theater Command
  Shenyang, China Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.