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Clinical Efficacy Study of "Tong Shu Yi Nao" Acupuncture Intervention for Post-Stroke Cognitive Impairment

Registration number：

ITMCTR2025000575

Date of Last Refreshed on：

2025-03-22

Date of Registration：

2025-03-22

Registration Status：

Prospective registration

Public title：

Clinical Efficacy Study of "Tong Shu Yi Nao" Acupuncture Intervention for Post-Stroke Cognitive Impairment

English Acronym：

Scientific title：

Clinical Efficacy Study of "Tong Shu Yi Nao" Acupuncture Intervention for Post-Stroke Cognitive Impairment

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

Applicant：

Mei Luo

Study leader：

Bo Li

Applicant telephone：

18723475907

Study leader's telephone：

13323332911

Applicant Fax：

Study leader's fax：

Applicant E-mail：

1643205314@qq.com

Study leader's E-mail：

ibou119@163.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

No.88 Changlin Road Xiqing District Tianjin China

Study leader's address：

No.88 Changlin Road Xiqing District Tianjin China

Applicant postcode：

Study leader's postcode：

Applicant's institution：

The First Teaching Hospital of Tianjin University of Traditional Chinese Medicine. The National Clinical Research Center for Chinese Medicine Acupuncture and Moxibustion

Approved by ethic committee：

Approved No. of ethic committee：

TYLL2024[Z]字076

Approved file of Ethical Committee：

View

Name of the ethic committee：

IRB of The First Teaching Hospital of Tianjin University of TCM

Date of approved by ethic committee：

2024/11/20 0:00:00

Contact Name of the ethic committee：

Ziqi Zheng

Contact Address of the ethic committee：

No.88 Changlin Road Xiqing District Tianjin China

Contact phone of the ethic committee：

022-27986258

Contact email of the ethic committee：

yfyiec@163.com

Primary sponsor：

The First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

Primary sponsor's address：

The First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

Secondary sponsor：

Country：

China

Province：

Tianjin

City：

Institution
hospital：

The First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

Address：

No.88 Changlin Road Xiqing District Tianjin China

Source(s) of funding：

self-raised

Target disease：

post-stroke cognitive impairment

Target disease code：

Study type：

Interventional study

Study design：

randomized controlled trial(parallel group design)

Study phase：

Pilot clinical trial

Objectives of Study：

Explore the effectiveness of "Tong Shu Yi Nao" acupuncture intervention for post-stroke cognitive impairment. Observe the safety of "Tong Shu Yi Nao" acupuncture intervention for post-stroke cognitive impairment. Monitor clinical adverse reactions and adverse events associated with acupuncture intervention.

Description for medicine or protocol of treatment in detail：

(1)Routine neurological treatment: According to the "Chinese Guidelines for Cerebrovascular Disease Prevention and Treatment" (issued by the Department of Disease Control of the Ministry of Health and the Chinese Medical Association Neurology Branch 2005) patients' basic indicators such as blood pressure blood sugar and blood lipids are controlled. Symptomatic treatment is provided and complications are prevented and managed.(2)Pharmacotherapy: Donepezil Hydrochloride (manufactured by Tianjin Lisheng Pharmaceutical Co. Ltd.) administered orally 5 mg once daily for a total treatment duration of 8 weeks.(3)"Tong Shu Yi Nao" Acupuncture Treatment: Acupoints selected: Shuigou (GV26) Neiguan (PC6) Sanyinjiao (SP6) Taichong (LR3) Fenglong (ST40) Baihui (GV20) Sishencong (EX-HN1) Shenmen (HT7) Fengchi (GB20) Wangu (GB12) Tianzhu (BL10) Sibai (ST2) and Jingjiaji (EX-B2).Procedure: The location of acupoints is determined according to the National Standard of the People's Republic of China for Nomenclature and Location of Meridian Points (GB/T 12346-2021) and the Nomenclature and Location of Extraordinary Points (GB/T 40997-2021). The participants assume a sitting or lateral position. Acupuncture is performed using Shi's acupuncture needles with a diameter of 0.25 mm and a length of 40 mm.Treatment frequency: Once daily 3 times per week for a total treatment duration of 8 weeks.

Inclusion criteria

(1) Meet the aforementioned diagnostic criteria; (2) Both genders are eligible aged between 35 and 75 years; (3) Cognitive impairment occurs within 6 months after stroke and persists for more than 3 months excluding other causes; (4) Montreal Cognitive Assessment (MoCA) score < 26; Mini-Mental State Examination (MMSE) score: >17 for those without formal education (illiterate) >20 for primary school education and >24 for secondary education and above; (5) Barthel Index (BI) score ≥ 60; (6) No acupuncture treatment received within the past month;(7) The patient or their family members have signed the informed consent form and are cooperative with the treatment.

Exclusion criteria：

(1) Patients with cognitive impairment prior to the onset of the stroke; (2) Patients with significant functional abnormalities in important organs such as the heart lungs liver and kidneys as well as in the hematopoietic system; (3) Patients with a history of diseases such as encephalitis epilepsy or other conditions that can cause dementia; (4) Patients with moderate to severe cognitive impairment who are unable to cooperate in completing the examinations; (5) Patients who are allergic to the medications used in the study or who cannot tolerate acupuncture have poor compliance or low tolerance. Patients currently participating in other clinical trials.

Study execute time：

From 2024-11-20

To      2025-11-20

Recruiting time：

From 2025-04-19

To      2025-11-19

Interventions：

42

Group：

treatment group

Sample size：

Intervention：

"Tong Shu Yi Nao" Acupuncture Treatment+Pharmacotherapy + Conventional Treatment

Intervention code：

42

Group：

control group

Sample size：

Intervention：

Pharmacotherapy + Conventional Treatment

Intervention code：

Total sample size ： 84

Countries of recruitment
and research settings：

Country：

China

Province：

Tianjin

City：

Institution/hospital：

First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

Level of the institution：

Tertiary A

Outcomes：

Outcome：

Event related potential（P300）

Type：

Secondary indicator

Measure time point of outcome：

0 4 8week

Measure method：

Computer Information Collection

Outcome：

Behavior experiment

Type：

Secondary indicator

Measure time point of outcome：

0 4 8week

Measure method：

Computer Information Collection

Outcome：

Montreal Cognitive Assessment

Type：

Primary indicator

Measure time point of outcome：

0 4 8week

Measure method：

scale

Outcome：

Minimum Mental State Examination

Type：

Secondary indicator

Measure time point of outcome：

0 4 8week

Measure method：

scale

Outcome：

Stroke Specific Quality of life scale

Type：

Secondary indicator

Measure time point of outcome：

0 4 8week

Measure method：

scale

Outcome：

Activity of Daily Living

Type：

Secondary indicator

Measure time point of outcome：

0 4 8week

Measure method：

scale

Collecting sample(s)
from participants：

Sample Name：

none

Tissue：

Fate of sample 

Destruction after use

Note：

Not yet recruiting

35
Min age years
75
Max age years

Recruiting status：

Participant age：

Gender：

Both

Randomization Procedure (please state who generates the random number sequence and by what method)：

The random number method was implemented using SPSS 25.0 software with generated numbers securely managed by authorized personnel.

Blinding：

single blind

IPD sharing：

No

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

Upon conclusion of the study, the original datasets generated during the research may be requested by contacting the corresponding author directly.

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

In this trial paper-based Case Report Forms (CRFs) are used for data collection. Investigators are required to accurately promptly completely and standardly transcribe data from source documents into the CRFs in accordance with the filling guidelines. After completion the CRFs are reviewed and signed by the investigator study physician Clinical Research Coordinator (CRC) and Clinical Research Associate (CRA) respectively. Any modifications made to the CRFs must include the reason for the change and leave a trace of the modification. Upon trial completion the time of data recording the recorder the audit trail of data and documents generated during the data management process should be preserved according to the corresponding Standard Operating Procedures (SOPs). The clinical trial institution must retain clinical trial documents for at least 5 years after the termination of the trial. Investigators should notify the sponsor in advance before destroying any trial-related documents or materials.

Data Managemen Committee：

Not yet

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

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