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

NCT05924308 | Unknown

• 1 other identifier: YD202219
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 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.

Conditions

Post-stroke Mild Cognitive Impairment

Keywords

Acupuncture therapy

Outcome Measures

Primary Outcomes (1)

• MMSE

  Mini-mental State Examination scale

  week (0,4,8,12,20)

Secondary Outcomes (4)

• MoCA

  week (0,4,8,12,20)

• MBI

  week (0,4,8,12,20)

• SSTCM

  week (0,4,8,12,20)

• SS-QOL

  week (0,4,8,12,20)

Study Arms (2)

control group

SHAM COMPARATOR

Other: sham acupuncture

treatment group

EXPERIMENTAL

Other: electroacupuncture

Interventions

electroacupuncture OTHER

every time 30 min, 1 times a day, five times a week, 4 weeks for 1 course of treatment, treatment 3 period of treatment.

treatment group

sham acupuncture OTHER

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.

control group

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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".

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai University of Traditional Chinese Medicine: lead

Study Sites (1)

Longhua Hospital, Shanghai university of TCM

Shanghai, Shanghai Municipality, 200031, China

RECRUITING

MeSH Terms

Interventions

Electroacupuncture

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Acupuncture Therapy; Complementary Therapies; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Transcutaneous Electric Nerve Stimulation; Analgesia; Anesthesia and Analgesia; Anesthesia

Central Study Contacts

Jia Xu, Doctor

CONTACT

+86 13564350018; hotohorij@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2023
• First Posted: June 29, 2023
• Study Start: September 1, 2022
• Primary Completion: March 31, 2024
• Study Completion: May 31, 2025
• Last Updated: June 29, 2023

Record last verified: 2022-09

Locations

CN (1)