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

Shanghai University of Traditional Chinese Medicine

Status: Unknown

Conditions: Acute Ischemia

Treatments: Other: Acupuncture Treatment; Other: Regular Treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT04528472

longhuaacup

Details and patient eligibility

About

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.

Full 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.

Enrollment: 194 estimated patients

Sex: All

Ages: 45 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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194 participants in 2 patient groups

Acupuncture Treatment

Experimental group

Description:

Acupuncture Treatment: main point: DU20, DU24, MS7, LI4, ST40 Oral Medicine Rehabilitation Treatment

Treatment:

Other: Acupuncture Treatment

Regular Treatment

Experimental group

Description:

Acupuncture Treatment Oral Medicine Rehabilitation Treatment

Treatment:

Other: Regular Treatment