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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05924308
Enrollment
60
Registered
2023-06-29
Start date
2022-09-01
Completion date
2025-05-31
Last updated
2023-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-stroke Mild Cognitive Impairment

Keywords

Acupuncture therapy

Brief summary

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.

Interventions

OTHERelectroacupuncture

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

OTHERsham 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.

Sponsors

Shanghai University of Traditional Chinese Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
MMSEweek (0,4,8,12,20)Mini-mental State Examination scale

Secondary

MeasureTime frameDescription
MoCAweek (0,4,8,12,20)Montreal Cognitive Assessment
MBIweek (0,4,8,12,20)Modified Barthel Index
SSTCMweek (0,4,8,12,20)
SS-QOLweek (0,4,8,12,20)

Countries

China

Contacts

Primary ContactJia Xu, Doctor
hotohorij@126.com+86 13564350018

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026