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Acupuncture Therapy for Post-stroke Mild Cognitive Impairment: a Randomized Controlled Trial

Primary Purpose

Post-stroke Mild Cognitive Impairment

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
electroacupuncture
sham acupuncture
Sponsored by
Shanghai University of Traditional Chinese Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-stroke Mild Cognitive Impairment focused on measuring Acupuncture therapy

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Meeting the diagnostic criteria: ① Stroke diagnostic criteria: according to the diagnostic criteria of cerebral infarction and cerebral hemorrhage in the "Chinese Guidelines for the Prevention and Treatment of Stroke (2021 edition)" issued by the National Health Commission, the diagnosis was confirmed by head CT or MRI examination. ② Mild cognitive impairment diagnostic criteria: according to the 2018 Chinese Guidelines for the Diagnosis and Treatment of Dementia and cognitive Impairment (5) : Diagnosis and treatment of mild cognitive Impairment. ③ TCM diagnostic criteria: according to the "TCM Diagnostic Efficacy Criteria" issued by the State Administration of Traditional Chinese Medicine in 2012, the patients were diagnosed as dementia. 40 years old ≤ age ≤75 years old, regardless of gender; cognitive impairment occurred after stroke without other causes; cognitive impairment within 6 months after stroke; stable condition, clear consciousness, MoCA score < 26 points; those who were willing to participate in the study and signed the "informed consent". Exclusion Criteria: Brain CT or MRI showed other lesions unrelated to stroke, or severe brain atrophy or leukoaraiosis; (2) serious complications (myocardial infarction, heart failure, malignant tumor, severe infection, mental illness, severe depression, epilepsy, etc.); with obvious hearing impairment, visual impairment, aphasia and other inability to cooperate in the physical evaluation; (4) pregnant or intended to pregnant women, lactating women; ⑤ intolerance to acupuncture; ⑥ bleeding tendency and poor coagulation function.

Sites / Locations

  • Longhua Hospital, Shanghai university of TCMRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

control group

treatment group

Arm Description

Outcomes

Primary Outcome Measures

MMSE
Mini-mental State Examination scale

Secondary Outcome Measures

MoCA
Montreal Cognitive Assessment
MBI
Modified Barthel Index
SSTCM
SS-QOL

Full Information

First Posted
June 20, 2023
Last Updated
June 20, 2023
Sponsor
Shanghai University of Traditional Chinese Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT05924308
Brief Title
Acupuncture Therapy for Post-stroke Mild Cognitive Impairment: a Randomized Controlled Trial
Official Title
Acupuncture Therapy for Post-stroke Mild Cognitive Impairment: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
May 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai University of Traditional Chinese Medicine

4. Oversight

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

5. Study Description

Brief Summary
On the basis of previous studies, standardized randomized controlled clinical trials were conducted to observe the efficacy and safety of acupuncture in the treatment of mild cognitive impairment after stroke using the international rating scale, and the clinical experience was transformed into evidence. According to the clinical outcomes reported by patients, the differences between Chinese and western scales in evaluating mild cognitive impairment after stroke were compared. On the basis of "disease differentiation, syndrome differentiation and meridian differentiation", the syndrome differentiation and treatment system of mild cognitive impairment after stroke was preliminarily constructed, and the TCM syndrome prediction model was improved.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-stroke Mild Cognitive Impairment
Keywords
Acupuncture therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
Sham Comparator
Arm Title
treatment group
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
electroacupuncture
Intervention Description
every time 30 min, 1 times a day, five times a week, 4 weeks for 1 course of treatment, treatment 3 period of treatment.
Intervention Type
Other
Intervention Name(s)
sham acupuncture
Intervention Description
Electroacupuncture was connected to the fixed place of Sishencong on the left and right sides of Baihui and Shenting, and the electroacupuncture instrument was returned to zero. Pull out the needle when informed patient for cotton on the above points, to make patients feel the needle was pulled out. The same treatment time of 30 min, 1 times a day, five times a week, 4 weeks for 1 course of treatment, treatment 3 period of treatment.
Primary Outcome Measure Information:
Title
MMSE
Description
Mini-mental State Examination scale
Time Frame
week (0,4,8,12,20)
Secondary Outcome Measure Information:
Title
MoCA
Description
Montreal Cognitive Assessment
Time Frame
week (0,4,8,12,20)
Title
MBI
Description
Modified Barthel Index
Time Frame
week (0,4,8,12,20)
Title
SSTCM
Time Frame
week (0,4,8,12,20)
Title
SS-QOL
Time Frame
week (0,4,8,12,20)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Meeting the diagnostic criteria: ① Stroke diagnostic criteria: according to the diagnostic criteria of cerebral infarction and cerebral hemorrhage in the "Chinese Guidelines for the Prevention and Treatment of Stroke (2021 edition)" issued by the National Health Commission, the diagnosis was confirmed by head CT or MRI examination. ② Mild cognitive impairment diagnostic criteria: according to the 2018 Chinese Guidelines for the Diagnosis and Treatment of Dementia and cognitive Impairment (5) : Diagnosis and treatment of mild cognitive Impairment. ③ TCM diagnostic criteria: according to the "TCM Diagnostic Efficacy Criteria" issued by the State Administration of Traditional Chinese Medicine in 2012, the patients were diagnosed as dementia. 40 years old ≤ age ≤75 years old, regardless of gender; cognitive impairment occurred after stroke without other causes; cognitive impairment within 6 months after stroke; stable condition, clear consciousness, MoCA score < 26 points; those who were willing to participate in the study and signed the "informed consent". Exclusion Criteria: Brain CT or MRI showed other lesions unrelated to stroke, or severe brain atrophy or leukoaraiosis; (2) serious complications (myocardial infarction, heart failure, malignant tumor, severe infection, mental illness, severe depression, epilepsy, etc.); with obvious hearing impairment, visual impairment, aphasia and other inability to cooperate in the physical evaluation; (4) pregnant or intended to pregnant women, lactating women; ⑤ intolerance to acupuncture; ⑥ bleeding tendency and poor coagulation function.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jia Xu, Doctor
Phone
+86 13564350018
Email
hotohorij@126.com
Facility Information:
Facility Name
Longhua Hospital, Shanghai university of TCM
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200031
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jia Xu, Doctor
Phone
+86 13564350018
Email
hotohorij@126.com

12. IPD Sharing Statement

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Acupuncture Therapy for Post-stroke Mild Cognitive Impairment: a Randomized Controlled Trial

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