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A Clinical Trail of Acupuncture and Herbs for Post-stroke Cogntive Impairment

Primary Purpose

Post-stroke Cognitive Impairment

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Chinese traditional rehabilitation
Sponsored by
The Third Affiliated hospital of Zhejiang Chinese Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-stroke Cognitive Impairment focused on measuring post-stroke cognitive impairment, rehabilitation, traditional Chinese medicine

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

-Cognitive disorder

  • Chinese medicine diagnosed as apoplexy;
  • The diagnosis of cerebral infarction or cerebral hemorrhage was consistent with western medicine by CT/MRI examination;
  • The course of disease ranges from 30 to 180 days;
  • First onset; Or come on in the past without the sequela such as limb paralysis; ·Age ≥18 years;
  • Informed consent signed by the legal guardian of the patient;
  • Montreal cognitive assessment scale (Montreal Cognitive Assessment, MoCA) score reaches a certain standard, MoCA scale score of 30 points, scored 17-26 points or less judged with cognitive impairment, if the education time 12 years or less on the basis of plus 1;
  • Hamilton depression scale (HAMD) < 20.
  • Meet the requirements of indications of acupuncture and moxibustion; Volunteer to participate in this project, the patient has no serious complications, can accept acupuncture treatment and good compliance.

Exclusion Criteria:

  • Cognitive disorder

    • Subarachnoid hemorrhage, transient ischemic attack, or with other intracranial lesions such as intracranial tumor, aneurysm, vascular malformation, cysticercosis, schistosomiasis, encephalitis, meningitis, hydrocephalus, brain trauma sequelae; ·Non-atherosclerotic thrombotic cerebral infarction (such as cardiogenic embolism, clotting status, endovascular shedding, arteritis, etc.);
    • Patients with severe primary chronic diseases such as heart, liver, kidney, viscera, endocrine system, hematopoietic system, serious disorders of language understanding, and mental disorders;
    • Suffered from a variety of bleeding tendency diseases;
    • Pregnant or lactating women;
    • Patients who do not meet the inclusion criteria, do not have poor treatment compliance as prescribed, which cannot judge the efficacy or incomplete data affect the efficacy judgment and are not suitable for clinical observation.

Sites / Locations

  • The Third Affiliated Hospital of Zhejiang Chinese Medical UniversityRecruiting
  • Hangzhou hospital of traditional Chinese medicineRecruiting
  • Jiaxing hospital of Chinese traditional medicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

control

treatment

Arm Description

basic treatment+ Cognitive rehabilitation training

basic treatment+ Cognitive rehabilitation training+Chinese traditional rehabilitation

Outcomes

Primary Outcome Measures

Change of Cognitive function
Montreal Cognitive Assessment(MOCA) will be used,this method focus on the sensitivity and specificity of the scale for the recognition of cognitive impairment are high, and it is evaluated from visual spatial/executive function, language function, image ability orientation and so on.

Secondary Outcome Measures

Changes in Daily Living ability
The scale has a total of 14 items, including two parts: one is the physical life self-care scale, with 6 items (going to the toilet, eating, dressing, grooming, walking and bathing); The second is the instrumental daily living ability scale, which consists of 8 items (telephone, shopping, meal preparation, housework, laundry, transportation, medication and self-care economy).
Changes in depressive status
use Hamilton Depression Scale to evaluate depression，the score were 24 for severe, 17 for moderate and 7 for mild.
Montreal cognitive assessment scale score change trend
analyse the change scale scores of different stages(Before intervention；After 8 weeks 、16 weeks 、24 weeks intervention) MOCA, the higher scores mean a better outcome
Changes in memory, attention and computational ability, language function
use MOCA to evaluate Memory, attention and calculation ability, language function
The rate of change in the scores of mini-Mental State Examination (MMSE)
analyse the change scale score of before intervention MMSE, higher scores mean a better outcome
Neural activity in the brain
The changes of the concentration of oxy-hemoglobin(HbO2), deoxy-hemoglobin (Hbb), cerebral blood flow (CBF) and cerebral blood volume of Functional near-infrared spectroscopy(fNIRS) will be analyzed
Changes in the patterns of related brain regions in cognitive impairment
use re-fMRI data of ALLF，ReHo，FC to evaluate brain function
Effective rate of cognitive function treatment
MoCA score will be calculated from baseline to 12 weeks of treatment and effective rate of treatment will follow the specific criteria. Recovery: the score increased by ≥90% compared with the baseline; Significant effective: the score increased between 70% and 89% compared with the baseline. Effective: the score increased between 30% and 69% compared with the baseline. Ineffective: the score increased < 30% compared with the baseline
Changes in the neurologic recovery
The Rankim Scale will be analyzed at baseline，0 week, 12 weeks to assess the changes in the neurologic recovery.

Full Information

First Posted
October 10, 2020
Last Updated
December 2, 2021
Sponsor
The Third Affiliated hospital of Zhejiang Chinese Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT04596072
Brief Title
A Clinical Trail of Acupuncture and Herbs for Post-stroke Cogntive Impairment
Official Title
A Clinical Trail of Acupuncture and Herbs for Post-stroke Cogntive Impairment
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
April 25, 2020 (Actual)
Primary Completion Date
May 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Third Affiliated hospital of Zhejiang Chinese Medical University

4. Oversight

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

5. Study Description

Brief Summary
The traditional Chinese medicine rehabilitation for the post-stroke cognitive impairment will be intervened, which can promote the recovery of post-stroke cognitive function patients, reduce the disability rate and improve the quality of life.
Detailed Description
This study will collect inpatients from April 2020 to December 2022 who from the third affiliated hospital of Zhejiang university of traditional Chinese medicine, Jiaxing hospital of traditional Chinese medicine, Hangzhou hospital of traditional Chinese medicine.this study sets strict time window (stroke recovery, 30-180 days), use multi-center, large sample, randomized controlled study method and the objective recognition rehabilitation evaluation criteria and efficacy evaluation system to evaluate the clinical effect and analysis of health economics.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-stroke Cognitive Impairment
Keywords
post-stroke cognitive impairment, rehabilitation, traditional Chinese medicine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
123 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
control
Arm Type
No Intervention
Arm Description
basic treatment+ Cognitive rehabilitation training
Arm Title
treatment
Arm Type
Experimental
Arm Description
basic treatment+ Cognitive rehabilitation training+Chinese traditional rehabilitation
Intervention Type
Combination Product
Intervention Name(s)
Chinese traditional rehabilitation
Intervention Description
Chinese traditional rehabilitation including acupuncture and herbs
Primary Outcome Measure Information:
Title
Change of Cognitive function
Description
Montreal Cognitive Assessment(MOCA) will be used,this method focus on the sensitivity and specificity of the scale for the recognition of cognitive impairment are high, and it is evaluated from visual spatial/executive function, language function, image ability orientation and so on.
Time Frame
baseline, 0 week, 8 weeks, 12 weeks
Secondary Outcome Measure Information:
Title
Changes in Daily Living ability
Description
The scale has a total of 14 items, including two parts: one is the physical life self-care scale, with 6 items (going to the toilet, eating, dressing, grooming, walking and bathing); The second is the instrumental daily living ability scale, which consists of 8 items (telephone, shopping, meal preparation, housework, laundry, transportation, medication and self-care economy).
Time Frame
0 week, 12 weeks, 16 weeks and 24 weeks
Title
Changes in depressive status
Description
use Hamilton Depression Scale to evaluate depression，the score were 24 for severe, 17 for moderate and 7 for mild.
Time Frame
0 week, 12 weeks, 16 weeks and 24 weeks
Title
Montreal cognitive assessment scale score change trend
Description
analyse the change scale scores of different stages(Before intervention；After 8 weeks 、16 weeks 、24 weeks intervention) MOCA, the higher scores mean a better outcome
Time Frame
at baseline, 0 week, 8 weeks, 12 weeks, 16 weeks and 24 weeks
Title
Changes in memory, attention and computational ability, language function
Description
use MOCA to evaluate Memory, attention and calculation ability, language function
Time Frame
at baseline, 12weeks
Title
The rate of change in the scores of mini-Mental State Examination (MMSE)
Description
analyse the change scale score of before intervention MMSE, higher scores mean a better outcome
Time Frame
at baseline, 0 week, 8 weeks, 12 weeks, 16 weeks and 24 weeks
Title
Neural activity in the brain
Description
The changes of the concentration of oxy-hemoglobin(HbO2), deoxy-hemoglobin (Hbb), cerebral blood flow (CBF) and cerebral blood volume of Functional near-infrared spectroscopy(fNIRS) will be analyzed
Time Frame
at baseline and 12 weeks
Title
Changes in the patterns of related brain regions in cognitive impairment
Description
use re-fMRI data of ALLF，ReHo，FC to evaluate brain function
Time Frame
at baseline and 12 weeks
Title
Effective rate of cognitive function treatment
Description
MoCA score will be calculated from baseline to 12 weeks of treatment and effective rate of treatment will follow the specific criteria. Recovery: the score increased by ≥90% compared with the baseline; Significant effective: the score increased between 70% and 89% compared with the baseline. Effective: the score increased between 30% and 69% compared with the baseline. Ineffective: the score increased < 30% compared with the baseline
Time Frame
at baseline, 0 week, 8 weeks, 12 weeks, 16 weeks and 24 weeks
Title
Changes in the neurologic recovery
Description
The Rankim Scale will be analyzed at baseline，0 week, 12 weeks to assess the changes in the neurologic recovery.
Time Frame
at baseline，0 week, 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: -Cognitive disorder Chinese medicine diagnosed as apoplexy; The diagnosis of cerebral infarction or cerebral hemorrhage was consistent with western medicine by CT/MRI examination; The course of disease ranges from 30 to 180 days; First onset; Or come on in the past without the sequela such as limb paralysis; ·Age ≥18 years; Informed consent signed by the legal guardian of the patient; Montreal cognitive assessment scale (Montreal Cognitive Assessment, MoCA) score reaches a certain standard, MoCA scale score of 30 points, scored 17-26 points or less judged with cognitive impairment, if the education time 12 years or less on the basis of plus 1; Hamilton depression scale (HAMD) < 20. Meet the requirements of indications of acupuncture and moxibustion; Volunteer to participate in this project, the patient has no serious complications, can accept acupuncture treatment and good compliance. Exclusion Criteria: Cognitive disorder Subarachnoid hemorrhage, transient ischemic attack, or with other intracranial lesions such as intracranial tumor, aneurysm, vascular malformation, cysticercosis, schistosomiasis, encephalitis, meningitis, hydrocephalus, brain trauma sequelae; ·Non-atherosclerotic thrombotic cerebral infarction (such as cardiogenic embolism, clotting status, endovascular shedding, arteritis, etc.); Patients with severe primary chronic diseases such as heart, liver, kidney, viscera, endocrine system, hematopoietic system, serious disorders of language understanding, and mental disorders; Suffered from a variety of bleeding tendency diseases; Pregnant or lactating women; Patients who do not meet the inclusion criteria, do not have poor treatment compliance as prescribed, which cannot judge the efficacy or incomplete data affect the efficacy judgment and are not suitable for clinical observation.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
XINYUN LI, Master
Phone
8618069783240
Email
lxyjasmine2010@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
RUIJIE MA, Doctor
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
RUIJIE MA, Doctor
Organizational Affiliation
The Third Affiliated hospital of Zhejiang Chinese Medical University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
XINYUN LI, Master
Organizational Affiliation
Zhejiang Chinese Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Third Affiliated Hospital of Zhejiang Chinese Medical University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ruijie Ma, Doctor
Phone
+86 18057102851
Email
maria7878@sina.com
First Name & Middle Initial & Last Name & Degree
Xinyun Li, Master
Phone
+86 18069783240
Email
lxyjasmine2010@163.com
First Name & Middle Initial & Last Name & Degree
Xinyun Li, Master
First Name & Middle Initial & Last Name & Degree
Kelin He, Master
First Name & Middle Initial & Last Name & Degree
Fengjia Ni, Undergraduate
Facility Name
Hangzhou hospital of traditional Chinese medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310002
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liping LI, Doctor
Phone
+86 13857161334
First Name & Middle Initial & Last Name & Degree
Liping LI, Doctor
Facility Name
Jiaxing hospital of Chinese traditional medicine
City
Jiaxing
State/Province
Zhejiang
ZIP/Postal Code
314000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kaitao LUO, Master
Phone
+86 13758395805
First Name & Middle Initial & Last Name & Degree
Kaitao LUO, Master

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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A Clinical Trail of Acupuncture and Herbs for Post-stroke Cogntive Impairment

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