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

December 2, 2021 updated by: Ruijie Ma, The Third Affiliated hospital of Zhejiang Chinese Medical University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

123

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: RUIJIE MA, Doctor

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000
        • Recruiting
        • the Third Affiliated Hospital of Zhejiang Chinese Medical University
        • Contact:
        • Principal Investigator:
          • Xinyun Li, Master
        • Sub-Investigator:
          • Fengjia Ni, Undergraduate
      • Hangzhou, Zhejiang, China, 310002
        • Recruiting
        • Hangzhou hospital of traditional Chinese medicine
      • Jiaxing, Zhejiang, China, 314000
        • Recruiting
        • Jiaxing hospital of Chinese traditional medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: control
basic treatment+ Cognitive rehabilitation training
Experimental: treatment
basic treatment+ Cognitive rehabilitation training+Chinese traditional rehabilitation
Combination product: Chinese traditional rehabilitation
Chinese traditional rehabilitation including acupuncture and herbs

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of Cognitive function
Time Frame: baseline, 0 week, 8 weeks, 12 weeks
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.
baseline, 0 week, 8 weeks, 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Daily Living ability
Time Frame: 0 week, 12 weeks, 16 weeks and 24 weeks
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).
0 week, 12 weeks, 16 weeks and 24 weeks
Changes in depressive status
Time Frame: 0 week, 12 weeks, 16 weeks and 24 weeks
use Hamilton Depression Scale to evaluate depression，the score were 24 for severe, 17 for moderate and 7 for mild.
0 week, 12 weeks, 16 weeks and 24 weeks
Montreal cognitive assessment scale score change trend
Time Frame: at baseline, 0 week, 8 weeks, 12 weeks, 16 weeks and 24 weeks
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
at baseline, 0 week, 8 weeks, 12 weeks, 16 weeks and 24 weeks
Changes in memory, attention and computational ability, language function
Time Frame: at baseline, 12weeks
use MOCA to evaluate Memory, attention and calculation ability, language function
at baseline, 12weeks
The rate of change in the scores of mini-Mental State Examination (MMSE)
Time Frame: at baseline, 0 week, 8 weeks, 12 weeks, 16 weeks and 24 weeks
analyse the change scale score of before intervention MMSE, higher scores mean a better outcome
at baseline, 0 week, 8 weeks, 12 weeks, 16 weeks and 24 weeks
Neural activity in the brain
Time Frame: at baseline and 12 weeks
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
at baseline and 12 weeks
Changes in the patterns of related brain regions in cognitive impairment
Time Frame: at baseline and 12 weeks
use re-fMRI data of ALLF，ReHo，FC to evaluate brain function
at baseline and 12 weeks
Effective rate of cognitive function treatment
Time Frame: at baseline, 0 week, 8 weeks, 12 weeks, 16 weeks and 24 weeks
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
at baseline, 0 week, 8 weeks, 12 weeks, 16 weeks and 24 weeks
Changes in the neurologic recovery
Time Frame: at baseline，0 week, 12 weeks
The Rankim Scale will be analyzed at baseline，0 week, 12 weeks to assess the changes in the neurologic recovery.
at baseline，0 week, 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Third Affiliated hospital of Zhejiang Chinese Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 25, 2020

Primary Completion (Anticipated)

May 31, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

October 10, 2020

First Submitted That Met QC Criteria

October 15, 2020

First Posted (Actual)

October 22, 2020

Study Record Updates

Last Update Posted (Actual)

December 16, 2021

Last Update Submitted That Met QC Criteria

December 2, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020ZJZS002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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