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

Ischemic Stroke Clinical Trial

— HOPES  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03629652
• Other study ID #: k(2018)25
• Status: Terminated
• Phase: N/A
• Start date: August 6, 2018
• Est. completion date: September 30, 2021

Study information

• Verified date: November 2021
• Source: General Hospital of Shenyang Military Region
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: September 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Other:
• head-down position treatment
In the head-down position, the body is in the supine position with the head lowered to 30 degrees
• Conventional Rehabilitation
The body is in the supine position without lowered head

Locations

Country	Name	City	State
China	General Hospital of ShenYang Military Region	ShenYang	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
General Hospital of Shenyang Military Region

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	proportion of patients with modified Rankin Score 0 to 2		90 days
Secondary	proportion of patients with modified Rankin Score 0 to 1		90 days
Secondary	The percentage of reduction in Fugl-Meyer score		90 days
Secondary	occurrence of stroke	stroke or TIA	90 days
Secondary	The percentage of reduction in MMSE	MMSE,Mini-mental State Examination	90 days
Secondary	The percentage of reduction in MoCA	MoCA, Montreal Congnitive Assessment	90 days
Secondary	Incidence of major vascular events	ischemic stroke, hemorrhagic stroke, TIA, myocardial infarction, vascular death	90 days
Secondary	the biggest tolerance time of head-down		90 days