Clinical trial NCT05924308: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Post-stroke Mild Cognitive Impairment
Keywords: Acupuncture therapy
Lead sponsor: Shanghai University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2023-06-29
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: MMSE
timeFrame: week (0,4,8,12,20)
Secondary outcomes:
measure: MoCA
timeFrame: week (0,4,8,12,20)
measure: MBI
timeFrame: week (0,4,8,12,20)
measure: SSTCM
timeFrame: week (0,4,8,12,20)
measure: SS-QOL
timeFrame: week (0,4,8,12,20)
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Longhua Hospital, Shanghai university of TCM
state: Shanghai
Study officials:
References: