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

• ClinicalTrials.gov Identifier: NCT03629652
• Recruitment Status: Terminated
• First Posted: August 14, 2018
• Last Update Posted: November 15, 2021
• Sponsor: General Hospital of Shenyang Military Region
• Information provided by (Responsible Party): Hui-Sheng Chen, General Hospital of Shenyang Military Region

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Ischemic Stroke	Other: head-down position treatment; Other: Conventional Rehabilitation	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 12 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Head-dOwn Position for ischEmic Stroke With Middle Cerebral Artery (HOPES): a Prospective, Random, Multi-Center, Pilot Trial
• Actual Study Start Date: August 6, 2018
• Actual Primary Completion Date: June 30, 2021
• Actual Study Completion Date: September 30, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. proportion of patients with modified Rankin Score 0 to 2 [ Time Frame: 90 days ]

Secondary Outcome Measures :

1. proportion of patients with modified Rankin Score 0 to 1 [ Time Frame: 90 days ]
2. The percentage of reduction in Fugl-Meyer score [ Time Frame: 90 days ]
3. occurrence of stroke [ Time Frame: 90 days ]
   stroke or TIA
4. The percentage of reduction in MMSE [ Time Frame: 90 days ]
   MMSE，Mini-mental State Examination
5. The percentage of reduction in MoCA [ Time Frame: 90 days ]
   MoCA, Montreal Congnitive Assessment
6. Incidence of major vascular events [ Time Frame: 90 days ]
   ischemic stroke, hemorrhagic stroke, TIA, myocardial infarction, vascular death
7. the biggest tolerance time of head-down [ Time Frame: 90 days ]

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

China, Liaoning

General Hospital of ShenYang Military Region

ShenYang, Liaoning, China

Sponsors and Collaborators

General Hospital of Shenyang Military Region

Investigators

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

More Information

• Responsible Party: Hui-Sheng Chen, Director of neurological department, General Hospital of Shenyang Military Region
• ClinicalTrials.gov Identifier: NCT03629652
• Other Study ID Numbers: k(2018)25
• First Posted: August 14, 2018
• Last Update Posted: November 15, 2021
• Last Verified: November 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hui-Sheng Chen, General Hospital of Shenyang Military Region:

head-down position; ischemic stroke; rehabilitation

Additional relevant MeSH terms:

Stroke; Ischemic Stroke; Cerebral Infarction; Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Brain Infarction; Brain Ischemia; Infarction; Necrosis