Head-dOwn Position for ischEmic Stroke With Middle Cerebr... | NCT03629652

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

NCT03629652

Sponsor

General Hospital of Shenyang Military Region

Status

Terminated

Last Update Posted

Nov 15, 2021Actual

Enrollment

12Actual

Phase

Not Applicable

Conditions

Ischemic Stroke

Interventions

head-down position treatment
Conventional Rehabilitation

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2021

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

it is hard to enroll the patients

Expanded Access Info

Start Date

Aug 6, 2018Actual

Primary Completion Date

Jun 30, 2021Actual

Completion Date

Sep 30, 2021Actual

First Submitted Date

Aug 6, 2018

First Submission Date that Met QC Criteria

Aug 12, 2018

First Posted Date

Aug 14, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 7, 2021

Last Update Posted Date

Nov 15, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hui-Sheng Chen, Director of neurological department, General Hospital of Shenyang Military RegionPrincipal Investigator

Lead Sponsor

General Hospital of Shenyang Military RegionOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Head down position	Experimental	head-down position treatment combined with conventional rehabilitation.	Other: head-down position treatment Other: Conventional Rehabilitation
Conventional Rehabilitation	Sham Comparator	Conventional rehabilitation treatment	Other: Conventional Rehabilitation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
head-down position treatment	Other	In the head-down position, the body is in the supine position with the head lowered to 30 degrees	Head down position

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age ≥18 years
acute ischemic stroke within 10 - 30 days of onset
neurological deficit: 6≤NIHSS≤16
Large artery atherosclerosis stroke based on TOAST criteria
The responsibility vessels were the middle cerebral artery or internal carotid artery, and the degree of stenosis was more than 50%.
first stroke onset or past stroke without obvious neurological deficit (mRS≤1)
fully understand and cooperate with the doctor's instructions.
the availability of informed consent;

Exclusion Criteria:

Hemorrhagic stroke or mixed stroke
Combining with severe organ dysfunction
Past hemorrhagic stroke
A history of stroke with severe sequelae
Planning revascularization in 3 months
Ischemic stroke due to surgical intervention
participating in other clinical trials within 3 months
Pregnant or lactating women
any inappropriate patients assessed by the researcher

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hui-Sheng Chen, doctor	General Hospital of Shenyang Military Region	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
General Hospital of ShenYang Military Region		Shenyang	Liaoning		China

Condition Browse Module

MeSH Terms

ID	Term
D000083242	Ischemic Stroke

Ancestor Terms

ID	Term
D020521	Stroke
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided