A Clinical Trail of Acupuncture and Herbs for Post-stroke Cogntive Impairment

Post-stroke Cognitive Impairment Clinical Trial

Official title:

A Clinical Trail of Acupuncture and Herbs for Post-stroke Cogntive Impairment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04596072
• Other study ID #: 2020ZJZS002
• Status: Recruiting
• Phase: N/A
• Start date: April 25, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: December 2021
• Source: The Third Affiliated hospital of Zhejiang Chinese Medical University
• Contact: XINYUN LI, Master
• Phone: 8618069783240
• Email: lxyjasmine2010[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The traditional Chinese medicine rehabilitation for the post-stroke cognitive impairment will be intervened, which can promote the recovery of post-stroke cognitive function patients, reduce the disability rate and improve the quality of life.

Description:

This study will collect inpatients from April 2020 to December 2022 who from the third affiliated hospital of Zhejiang university of traditional Chinese medicine, Jiaxing hospital of traditional Chinese medicine, Hangzhou hospital of traditional Chinese medicine.this study sets strict time window (stroke recovery, 30-180 days), use multi-center, large sample, randomized controlled study method and the objective recognition rehabilitation evaluation criteria and efficacy evaluation system to evaluate the clinical effect and analysis of health economics.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 123
• Est. completion date: December 31, 2023
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

-Cognitive disorder

• Chinese medicine diagnosed as apoplexy;
• The diagnosis of cerebral infarction or cerebral hemorrhage was consistent with western medicine by CT/MRI examination;
• The course of disease ranges from 30 to 180 days;
• First onset; Or come on in the past without the sequela such as limb paralysis; ·Age =18 years;
• Informed consent signed by the legal guardian of the patient;
• Montreal cognitive assessment scale (Montreal Cognitive Assessment, MoCA) score reaches a certain standard, MoCA scale score of 30 points, scored 17-26 points or less judged with cognitive impairment, if the education time 12 years or less on the basis of plus 1;
• Hamilton depression scale (HAMD) < 20.
• Meet the requirements of indications of acupuncture and moxibustion; Volunteer to participate in this project, the patient has no serious complications, can accept acupuncture treatment and good compliance.

Exclusion Criteria:

• Cognitive disorder
• Subarachnoid hemorrhage, transient ischemic attack, or with other intracranial lesions such as intracranial tumor, aneurysm, vascular malformation, cysticercosis, schistosomiasis, encephalitis, meningitis, hydrocephalus, brain trauma sequelae; ·Non-atherosclerotic thrombotic cerebral infarction (such as cardiogenic embolism, clotting status, endovascular shedding, arteritis, etc.);
• Patients with severe primary chronic diseases such as heart, liver, kidney, viscera, endocrine system, hematopoietic system, serious disorders of language understanding, and mental disorders;
• Suffered from a variety of bleeding tendency diseases;
• Pregnant or lactating women;
• Patients who do not meet the inclusion criteria, do not have poor treatment compliance as prescribed, which cannot judge the efficacy or incomplete data affect the efficacy judgment and are not suitable for clinical observation.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Post-stroke Cognitive Impairment
• Stroke

Intervention

Combination Product:
• Chinese traditional rehabilitation
Chinese traditional rehabilitation including acupuncture and herbs

Locations

Country	Name	City	State
China	Hangzhou hospital of traditional Chinese medicine	Hangzhou	Zhejiang
China	The Third Affiliated Hospital of Zhejiang Chinese Medical University	Hangzhou	Zhejiang
China	Jiaxing hospital of Chinese traditional medicine	Jiaxing	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
The Third Affiliated hospital of Zhejiang Chinese Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of Cognitive function	Montreal Cognitive Assessment(MOCA) will be used,this method focus on the sensitivity and specificity of the scale for the recognition of cognitive impairment are high, and it is evaluated from visual spatial/executive function, language function, image ability orientation and so on.	baseline, 0 week, 8 weeks, 12 weeks
Secondary	Changes in Daily Living ability	The scale has a total of 14 items, including two parts: one is the physical life self-care scale, with 6 items (going to the toilet, eating, dressing, grooming, walking and bathing); The second is the instrumental daily living ability scale, which consists of 8 items (telephone, shopping, meal preparation, housework, laundry, transportation, medication and self-care economy).	0 week, 12 weeks, 16 weeks and 24 weeks
Secondary	Changes in depressive status	use Hamilton Depression Scale to evaluate depression,the score were 24 for severe, 17 for moderate and 7 for mild.	0 week, 12 weeks, 16 weeks and 24 weeks
Secondary	Montreal cognitive assessment scale score change trend	analyse the change scale scores of different stages(Before intervention;After 8 weeks ?16 weeks ?24 weeks intervention) MOCA, the higher scores mean a better outcome	at baseline, 0 week, 8 weeks, 12 weeks, 16 weeks and 24 weeks
Secondary	Changes in memory, attention and computational ability, language function	use MOCA to evaluate Memory, attention and calculation ability, language function	at baseline, 12weeks
Secondary	The rate of change in the scores of mini-Mental State Examination (MMSE)	analyse the change scale score of before intervention MMSE, higher scores mean a better outcome	at baseline, 0 week, 8 weeks, 12 weeks, 16 weeks and 24 weeks
Secondary	Neural activity in the brain	The changes of the concentration of oxy-hemoglobin(HbO2), deoxy-hemoglobin (Hbb), cerebral blood flow (CBF) and cerebral blood volume of Functional near-infrared spectroscopy(fNIRS) will be analyzed	at baseline and 12 weeks
Secondary	Changes in the patterns of related brain regions in cognitive impairment	use re-fMRI data of ALLF,ReHo,FC to evaluate brain function	at baseline and 12 weeks
Secondary	Effective rate of cognitive function treatment	MoCA score will be calculated from baseline to 12 weeks of treatment and effective rate of treatment will follow the specific criteria. Recovery: the score increased by =90% compared with the baseline; Significant effective: the score increased between 70% and 89% compared with the baseline. Effective: the score increased between 30% and 69% compared with the baseline. Ineffective: the score increased < 30% compared with the baseline	at baseline, 0 week, 8 weeks, 12 weeks, 16 weeks and 24 weeks
Secondary	Changes in the neurologic recovery	The Rankim Scale will be analyzed at baseline,0 week, 12 weeks to assess the changes in the neurologic recovery.	at baseline,0 week, 12 weeks