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

Shanghai University of Traditional Chinese Medicine

Status: Enrolling

Conditions: Post-stroke Mild Cognitive Impairment

Treatments: Other: sham acupuncture; Other: electroacupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT05924308

YD202219

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

control group

Sham Comparator group

Treatment:

Other: sham acupuncture

treatment group

Experimental group

Treatment:

Other: electroacupuncture