Acute Ischemic Apoplexy Syndrome Specificity and Acupuncture Intervention Research (AIAI)

Longhua Hospital, Shanghai University of TCM

This project optimizes the TCM Symptoms and Symptoms Scale. A curative effect evaluation system of acupuncture in the treatment of acute ischemic stroke is formed to provide clinical evidence by the following indexes: neurological impairment, motor dysfunction, TCM Symptoms and Symptoms Scale, combined with the patients' head MRI, Plasma BDNF, MMP-9 and other biomarkers.

Study Overview

• Status: Unknown
• Conditions: Acute Ischemia
• Intervention / Treatment: Other: Acupuncture Treatment; Other: Regular Treatment

Detailed Description

Based on the previous work, this project optimizes the TCM Symptoms and Symptoms Scale. Through the cohort study method, 194 patients with acute ischemic stroke were evaluated for neurological impairment, motor dysfunction, TCM Symptoms and Symptoms Scale, combined with the patients' head MRI. , Plasma BDNF, MMP-9 and other biomarkers, screen TCM syndromes related to stroke outcome indicators, and adopt targeted comprehensive acupuncture and moxibustion program intervention and follow-up to establish a stroke-specific intervention outcome prediction model with TCM characteristics. A curative effect evaluation system of acupuncture and moxibustion in the treatment of acute ischemic stroke is formed to provide clinical evidence.

• Study Type: Interventional
• Enrollment (Anticipated): 194
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• (1) It meets the diagnostic criteria in the "Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2014"; with the support of brain CT or MRI imaging examination, the vital signs are stable, the state of consciousness is clear, and the GCS>8 points; （2）.Onset is less than 2 weeks; （3）. There is no indication for thrombolysis, or the patient do not accept thrombolysis; （4）. For moderate to severe patients, the National Institute of Health Stroke Scale (NIHSS) ≥ 4 points;（5）.Glasgow coma standard (GCS)>7 points;（6）.No serious disability before admission, and modified Rankin Scale (mRS) ≤ 3;（7）. The patient himself or his immediate family members signed the informed consent form.

Exclusion Criteria:

- (1) Cerebral hemorrhage or subarachnoid hemorrhage; (2) Cerebellar and brainstem infarction (including lacunar infarction); (3) Cerebral herniation is formed upon admission; (4) Patients with severe heart, lung, liver, and kidney diseases; (5) Severe upper gastrointestinal bleeding occurred after the onset; (6) The patient has participated in other clinical trials within the past 3 months; (7) Patients with mental illness, or those with severe cognitive impairment (MMSE score ≤9 points) (8) Those with a pacemaker, a metal foreign body at the treatment site, or a severe bleeding tendency.

(9) The investigator believes that other diseases accompanied by the patient may interfere with the correct evaluation of neurological function, or participating in this trial may cause other complications in the patient.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Acupuncture Treatment; Acupuncture Treatment: main point: DU20, DU24, MS7, LI4, ST40 Oral Medicine Rehabilitation Treatment	Other: Acupuncture Treatment; stimulate acupoints to accelerate recovery
EXPERIMENTAL: Regular Treatment; Acupuncture Treatment Oral Medicine Rehabilitation Treatment	Other: Regular Treatment; Oral Medicine and Rehabilitation Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
NIHSS SCALE	NIHSS was created by the National Institutes of Health and has good reliability and validity. It has been widely used to evaluate the severity and prognosis of stroke. The scale consists of consciousness, gaze, vision, facial paralysis, movement, sensation, mutual aid, language, neglect and other items, with a maximum score of 33 points.	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stroke Scale of Traditional Chinese Medicine, SSTCM	SSTCM mainly includes two parts: TCM symptoms and tongue and pulse conditions. There are a total of 24 symptoms of TCM symptoms. According to their severity and impact on daily life, each item is scored into 4 grades, with 0 points for normal, 1 point for mild, 2 points for moderate, and 3 points for severe. Tongue and pulse conditions are only recorded and not scored. The total score is the sum of the scores of TCM symptoms in Part 1. The higher the score, the more severe the symptoms and the greater the impact on life.	4 weeks
modified Barthel Index, mBI	The mBI scale is mainly used to evaluate the self-care ability of patients in daily life. It can be summarized as the patients' independent activities in an indoor environment, such as eating, dressing, and toileting, with a total of ten items. The score of each item is divided into 5 levels, the lowest is 1 and the highest is 5. The higher the level, the greater the independence, and the total score is 100 points.	4 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
CRP	acute ischemic biomarker	baseline ,4 weeks
BDNF	acute ischemic biomarker	baseline ,4 weeks
MMP-9	acute ischemic biomarker	baseline ,4 weeks

Collaborators and Investigators

• Sponsor: Shanghai University of Traditional Chinese Medicine
• Investigators: Study Director: jian pei, doctor, Longhua Hospital

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): October 1, 2020
• Primary Completion (ANTICIPATED): May 1, 2022
• Study Completion (ANTICIPATED): October 1, 2022

Study Registration Dates

• First Submitted: August 24, 2020
• First Submitted That Met QC Criteria: August 26, 2020
• First Posted (ACTUAL): August 27, 2020

Study Record Updates

• Last Update Posted (ACTUAL): August 27, 2020
• Last Update Submitted That Met QC Criteria: August 26, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Ischemia
• Other Study ID Numbers: longhuaacup

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No