NCT03744533

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

Head-down Position for Acute Ischemic Stroke With Large Artery Atherosclerosis: a Prospective, Random, Multi-Center, Pilot Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: General Hospital of Shenyang Military Region · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Ischemic Stroke

Interventions

Type	Name	Description
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

Timeline

• Start date: 2018-11-26
• Primary completion: 2021-08-28
• Completion: 2021-08-28
• First posted: 2018-11-16
• Last updated: 2021-09-28

Locations

1 site across 1 country: China