Head-down Position for Acute Ischemic Stroke With Large Artery Atherosclerosis

NCT03744533 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2021-09-28

No results posted yet for this study

Summary

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 preliminary clinical experiments show that head-down position may 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.The study is designed to explore the efficacy and safety of head-down position in patients with acute ischemic stroke

Conditions

Interventions

OTHER

head-down position treatment

the head position of subjects is lowered to 20 degrees in a supine position between 8:00-22:00 within 24h post-randomization as long as possible. During the procedure, when subjects feel intolerable, the head position will be elevated to lying flat (0 degree) for 5-10min, and then the above procedure is repeated. After 24h post-randomization, the head down procedures with -20 degrees in a supine position with duration of 1-1.5 hour will be performed three times daily at 9:00-11:00, 15:00-17:00 and 20:00-22:00, respectively.

OTHER

guideline-based treatment

guideline-based treatment

Sponsors & Collaborators

  • General Hospital of Shenyang Military Region

    lead OTHER

Principal Investigators

  • Huisheng Chen, Doctor · Neurology Department

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-26
Primary Completion
2021-08-28
Completion
2021-08-28

Countries

  • China

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03744533 on ClinicalTrials.gov