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

Head-dOwn Position for ischEmic Stroke With Middle Cerebral Artery (HOPES): a Prospective, Random, Multi-Center, Pilot Trial

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

Study Overview

• Status: Terminated
• Conditions: Ischemic Stroke
• Intervention / Treatment: Other: head-down position treatment; Other: Conventional Rehabilitation

Detailed Description

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
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Liaoning
    • ShenYang, Liaoning, China
      • General Hospital of Shenyang Military Region

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Head down position; head-down position treatment combined with conventional rehabilitation.	Other: head-down position treatment; In the head-down position, the body is in the supine position with the head lowered to 30 degrees; Other: Conventional Rehabilitation; The body is in the supine position without lowered head
Sham Comparator: Conventional Rehabilitation; Conventional rehabilitation treatment	Other: Conventional Rehabilitation; The body is in the supine position without lowered head

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
proportion of patients with modified Rankin Score 0 to 2	90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
proportion of patients with modified Rankin Score 0 to 1		90 days
The percentage of reduction in Fugl-Meyer score		90 days
occurrence of stroke	stroke or TIA	90 days
The percentage of reduction in MMSE	MMSE，Mini-mental State Examination	90 days
The percentage of reduction in MoCA	MoCA, Montreal Congnitive Assessment	90 days
Incidence of major vascular events	ischemic stroke, hemorrhagic stroke, TIA, myocardial infarction, vascular death	90 days
the biggest tolerance time of head-down		90 days

Collaborators and Investigators

• Sponsor: General Hospital of Shenyang Military Region
• Investigators: Principal Investigator: Hui-Sheng Chen, doctor, General Hospital of Shenyang Military Region

Study record dates

Study Major Dates

• Study Start (Actual): August 6, 2018
• Primary Completion (Actual): June 30, 2021
• Study Completion (Actual): September 30, 2021

Study Registration Dates

• First Submitted: August 6, 2018
• First Submitted That Met QC Criteria: August 12, 2018
• First Posted (Actual): August 14, 2018

Study Record Updates

• Last Update Posted (Actual): November 15, 2021
• Last Update Submitted That Met QC Criteria: November 7, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: rehabilitation; ischemic stroke; head-down position
• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Infarction; Brain Infarction; Stroke; Ischemic Stroke; Ischemia; Cerebral Infarction
• Other Study ID Numbers: k(2018)25

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No