Back to resultsAcute Ischemic Apoplexy Syndrome Specificity and Acupuncture Intervention Research (AIAI)
Primary Purpose
Acute Ischemia
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Acupuncture Treatment
Regular Treatment
Sponsored by
About this trial
This is an interventional prevention trial for Acute Ischemia
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Acupuncture Treatment
Regular Treatment
Arm Description
Acupuncture Treatment: main point: DU20, DU24, MS7, LI4, ST40 Oral Medicine Rehabilitation Treatment
Acupuncture Treatment Oral Medicine Rehabilitation Treatment
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT04528472
First Posted
August 24, 2020
Last Updated
August 26, 2020
Sponsor
Shanghai University of Traditional Chinese Medicine
1. Study Identification
Unique Protocol Identification Number
NCT04528472
Brief Title
Acute Ischemic Apoplexy Syndrome Specificity and Acupuncture Intervention Research
Acronym
AIAI
Official Title
Longhua Hospital, Shanghai University of TCM
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2020 (Anticipated)
Primary Completion Date
May 1, 2022 (Anticipated)
Study Completion Date
October 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai University of Traditional Chinese Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Ischemia
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Non-Randomized
Enrollment
194 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Acupuncture Treatment
Arm Type
Experimental
Arm Description
Acupuncture Treatment: main point: DU20, DU24, MS7, LI4, ST40 Oral Medicine Rehabilitation Treatment
Arm Title
Regular Treatment
Arm Type
Experimental
Arm Description
Acupuncture Treatment Oral Medicine Rehabilitation Treatment
Intervention Type
Other
Intervention Name(s)
Acupuncture Treatment
Intervention Description
stimulate acupoints to accelerate recovery
Intervention Type
Other
Intervention Name(s)
Regular Treatment
Intervention Description
Oral Medicine and Rehabilitation Treatment
Primary Outcome Measure Information:
Title
NIHSS SCALE
Description
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.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Stroke Scale of Traditional Chinese Medicine, SSTCM
Description
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.
Time Frame
4 weeks
Title
modified Barthel Index, mBI
Description
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.
Time Frame
4 weeks
Other Pre-specified Outcome Measures:
Title
CRP
Description
acute ischemic biomarker
Time Frame
baseline ,4 weeks
Title
BDNF
Description
acute ischemic biomarker
Time Frame
baseline ,4 weeks
Title
MMP-9
Description
acute ischemic biomarker
Time Frame
baseline ,4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
qinhui fu, doctor
Phone
008613795396770
Email
ff777315@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
yijun zhan, master
Phone
008602164385700
Ext
3534
Email
jennifer911218@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
jian pei, doctor
Organizational Affiliation
Longhua Hospital
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Acute Ischemic Apoplexy Syndrome Specificity and Acupuncture Intervention Research
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