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

1. 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.
2. 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.

Study Overview

• Status: Recruiting
• Conditions: Post-stroke Mild Cognitive Impairment
• Intervention / Treatment: Other: sham acupuncture; Other: electroacupuncture

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jia Xu, Doctor; Phone Number: +86 13564350018; Email: hotohorij@126.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200031
      • Recruiting
      • Longhua Hospital, Shanghai university of TCM
      • Contact: Jia Xu, Doctor; Phone Number: +86 13564350018; Email: hotohorij@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 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.
2. 40 years old ≤ age ≤75 years old, regardless of gender;
3. cognitive impairment occurred after stroke without other causes;
4. cognitive impairment within 6 months after stroke;
5. stable condition, clear consciousness, MoCA score < 26 points;
6. 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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: treatment group	Other: electroacupuncture; every time 30 min, 1 times a day, five times a week, 4 weeks for 1 course of treatment, treatment 3 period of treatment.
Sham Comparator: control group	Other: sham acupuncture; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MMSE	Mini-mental State Examination scale	week (0,4,8,12,20)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MoCA	Montreal Cognitive Assessment	week (0,4,8,12,20)
MBI	Modified Barthel Index	week (0,4,8,12,20)
SSTCM		week (0,4,8,12,20)
SS-QOL		week (0,4,8,12,20)

Collaborators and Investigators

• Sponsor: Shanghai University of Traditional Chinese Medicine

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Estimated): March 31, 2024
• Study Completion (Estimated): May 31, 2025

Study Registration Dates

• First Submitted: June 20, 2023
• First Submitted That Met QC Criteria: June 20, 2023
• First Posted (Actual): June 29, 2023

Study Record Updates

• Last Update Posted (Actual): June 29, 2023
• Last Update Submitted That Met QC Criteria: June 20, 2023
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Acupuncture therapy
• Additional Relevant MeSH Terms: Mental Disorders; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Cognition Disorders; Stroke; Cognitive Dysfunction
• Other Study ID Numbers: YD202219

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No