Ischemic Stroke
Conditions
Keywords
head-down position, Large Artery Atherosclerosis
Brief 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
Interventions
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.
guideline-based treatment
Sponsors
General Hospital of Shenyang Military Region
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient age over 18 years 2. acute ischemic stroke within 24 h of onset 3. neurological deficit: 6≤NIHSS≤16 4. Large artery atherosclerosis etiology based on TOAST typing 5. the supplied vessel is 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. Signed informed consent
Exclusion criteria
1. Disturbance of consciousness 2. Hemorrhagic stroke or mixed stroke 3. Combining with severe organ dysfunction 4. Past hemorrhagic stroke 5. A history of stroke with severe sequelae 6. Planned revascularization within 3 months 7. Ischemic stroke due to surgical intervention 8. participating in other clinical trials within 3 months 9. Pregnant or lactating women 10. any inappropriate patient assessed by the researcher
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| proportion of modified Rankin Score of 0 to 2 | 90 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of modified Rankin Score of 0 to 1 | 90 days | — |
| proportion of early neurological deterioration | 48 hours | Early neurological deterioration, defined as more than 4 increase in National Institute of Health stroke scale score |
| The occurence of stroke or other vascular events | 90 days | — |
| proportion of death of any cause | 90 days | — |
Countries
China
Outcome results
None listed