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

• Sponsor: Shanghai University of Traditional Chinese Medicine (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05924308
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 33
• Patients Per Site Per Month: 1.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Post-stroke Mild Cognitive Impairment	Other: electroacupuncture; Other: sham acupuncture	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Acupuncture Therapy for Post-stroke Mild Cognitive Impairment: a Randomized Controlled Trial
• Actual Study Start Date: Sep 1, 2022
• Anticipated Primary Completion Date: Mar 31, 2024
• Anticipated Study Completion Date: May 31, 2025

Arms and Interventions

Arm	Intervention/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.
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.

Outcome Measures

Primary Outcome Measures

1. MMSE [week (0,4,8,12,20)]

   Mini-mental State Examination scale

Secondary Outcome Measures

1. MoCA [week (0,4,8,12,20)]

   Montreal Cognitive Assessment

2. MBI [week (0,4,8,12,20)]

   Modified Barthel Index

3. SSTCM [week (0,4,8,12,20)]

4. SS-QOL [week (0,4,8,12,20)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts 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.

1. 40 years old ≤ age ≤75 years old, regardless of gender;

2. cognitive impairment occurred after stroke without other causes;

3. cognitive impairment within 6 months after stroke;

4. stable condition, clear consciousness, MoCA score < 26 points;

5. 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Longhua Hospital, Shanghai university of TCM	Shanghai	Shanghai	China	200031

Sponsors and Collaborators

• Shanghai University of Traditional Chinese Medicine

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Shanghai University of Traditional Chinese Medicine
• ClinicalTrials.gov Identifier: NCT05924308
• Other Study ID Numbers: YD202219
• First Posted: Jun 29, 2023
• Last Update Posted: Jun 29, 2023
• Last Verified: Sep 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Shanghai University of Traditional Chinese Medicine: Acupuncture therapy
• Additional relevant MeSH terms: Stroke; Cognitive Dysfunction

Study Results

No Results Posted as of Jun 29, 2023