Clinical trial NCT03629652: Head-dOwn Position for ischEmic Stroke With Middle Cerebral Artery (HOPES)
Official title: Head-dOwn Position for ischEmic Stroke With Middle Cerebral Artery (HOPES): a Prospective, Random, Multi-Center, Pilot Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Ischemic Stroke
Keywords: head-down position
ischemic stroke
rehabilitation
Lead sponsor: General Hospital of Shenyang Military Region
Sponsor class: OTHER
First posted: 2018-08-14
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility 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

Primary outcomes:
measure: proportion of patients with modified Rankin Score 0 to 2
timeFrame: 90 days
Secondary outcomes:
measure: proportion of patients with modified Rankin Score 0 to 1
timeFrame: 90 days
measure: The percentage of reduction in Fugl-Meyer score
timeFrame: 90 days
measure: occurrence of stroke
timeFrame: 90 days
measure: The percentage of reduction in MMSE
timeFrame: 90 days
measure: The percentage of reduction in MoCA
timeFrame: 90 days
measure: Incidence of major vascular events
timeFrame: 90 days
measure: the biggest tolerance time of head-down
timeFrame: 90 days
Other outcomes:
Locations:
city: ShenYang
country: China
facility: General Hospital of ShenYang Military Region
state: Liaoning
Study officials:
affiliation: General Hospital of Shenyang Military Region
name: Hui-Sheng Chen, doctor
role: PRINCIPAL_INVESTIGATOR
References: