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Most ischemic stroke patients are in recovery phase, often accompanied by motor impairment, but they lack effective treatment. The appearance of nerve growth factor (NGF) promotes the development of neuroprotective therapy, but it has little effect on stroke because of the blood-brain barrier (BBB). Electroacupuncture (EA) has been used for stroke, while there is no significant clinical effect for recovery phrase. Consequently, we will conduct a multicentre, randomised, controlled, assessor-blinded clinical trial to assess the effectiveness and safety of EA combined with NGF treatment on ischemic stroke recovery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| sham EA + placebo group | Placebo Comparator | The sham EA intervention a is that the stimulator is connected to the needle handle on GV20 and GV26 without power for 40 min intervention,once a day for 4 weeks;The patients will receive 1ml volume of physiological saline (PS) injected into the gluteal muscle, once a day for 4 weeks before the sham EA intervention. |
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| EA + placebo group | Active Comparator | Patients take supine position. After skin disinfection with 75% ethanol routine disinfection, the stainless needle will be inserted in GV20(Baihui) and the stainless needle will be inserted in GV26 (Shuigou), acupoints will be stimulated manually until patients feel soreness, distension or heaviness (the reaction of "De Qi"). Then, the needles are stimulated by using an acupuncture point nerve stimulator (HANS-200, Nanjing Jinsheng, Ltd., China) with a frequency of 2/100 Hz and an intensity of 3 mA for 40 min (a homemade relay cycled power to the electrode for 6 sec on and 6 sec off), 28 days as a course of treatment, once a day;The patients will receive 1ml volume of physiological saline (PS) injected into the gluteal muscle, once a day for 4 weeks before the EA intervention. |
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| sham EA + NGF group | Active Comparator | The sham EA intervention a is that the stimulator is connected to the needle handle on GV20 and GV26 without power for 40 min intervention,once a day for 4 weeks;The 20ug nerve growth factor will be obtained from Hiteck Biopharmaceutical Co., Ltd, Wuhan, China. mNGF will be dissolved in 1 ml sterile water for injection and then injected intramuscularly at gluteal muscle, once a day for 4 weeks before the sham EA intervention. Dose modification is not allowed for mNGF. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nerve growth factor | Drug | The patient first received an intramuscular injection of NGF or saline into the gluteus maximus.The 20ug nerve growth factor (NO.S20060051, Jinlujie) will be obtained from Hiteck Biopharmaceutical Co., Ltd, Wuhan, China. mNGF will be dissolved in 1 ml sterile water for injection and then injected intramuscularly at gluteal muscle, once a day for 4 weeks. Dose modification is not allowed for mNGF. |
| Measure | Description | Time Frame |
|---|---|---|
| the modified Rankin Score | the modified Rankin Score is a common indicator to evaluate motor function in stroke patients.The modified Rankin Score ranges from 0 to 6, and the more severe the neurological deficit, the higher the score. | the end of treatment (week 4) in all four groups. |
| Measure | Description | Time Frame |
|---|---|---|
| Fugl-Meyer Assessment of motor function score (FMA) | Fugl-Meyer Assessment of motor function score (FMA) is a common indicator to evaluate motor function.simplified Fugl-Meyer Assessment of motor function score sums up a total score (maximum 100 points ), including an assessment of the upper extremity (maximum 66 points) and lower extremity (maximum 34 points). | Fugl-Meyer Assessment of motor function score (FMA) is recorded at baseline (week 0), Mid-term treatment (week 2) and end of treatment (week 4) in all four groups. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yuan yuan WU, PHD | Contact | 0571-88393504 | +86 | zskjk08@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Third Affiliated Hospital of Zhejiang Chinese Medical University | Recruiting | Hangzhou | Zhejiang | 310000 | China |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D003289 | Convalescence |
| D009477 | Hereditary Sensory and Autonomic Neuropathies |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D020932 | Nerve Growth Factor |
| ID | Term |
|---|---|
| D009414 | Nerve Growth Factors |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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people who are14 days to 6 months after stroke onset
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In this trail, it's difficult to blind researchers, because they perform sham EA or EA, and inject NGF or placebo on patients. However, patients, independent outcome assessors and independent statisticians will be blinded to group allocation throughout the entire trial.
| EA + NGF group | Active Comparator | Patients take supine position. After skin disinfection with 75% ethanol routine disinfection, the stainless needle will be inserted in GV20(Baihui) and the stainless needle will be inserted in GV26 (Shuigou), acupoints will be stimulated manually until patients feel soreness, distension or heaviness . Then, the needles are stimulated by using an acupuncture point nerve stimulator , 28 days as a course of treatment, once a day;The 20ug nerve growth factor will be dissolved in 1 ml sterile water for injection and then injected intramuscularly at gluteal muscle, once a day for 4 weeks before the EA intervention. Dose modification is not allowed for mNGF. |
|
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| physiological saline | Drug | Other patients will receive 1ml volume of physiological saline (PS) injected into the gluteal muscle, once a day for 4 weeks. |
|
|
| EA | Device | Patients take supine position. After skin disinfection with 75% ethanol routine disinfection, the stainless needle (size 0.25mm×40mm, Hua Tuo brand, Suzhou Medical Supplies Company Ltd in Jiangsu, China) will be inserted in GV20(Baihui) and the stainless needle(size 0.25mm×25mm, described above) will be inserted in GV26 (Shuigou), acupoints will be stimulated manually until patients feel soreness, distension or heaviness (the reaction of "De Qi"). Then, the needles are stimulated by using an acupuncture point nerve stimulator (HANS-200, Nanjing Jinsheng, Ltd., China) with a frequency of 2/100 Hz and an intensity of 3 mA for 40 min (a homemade relay cycled power to the electrode for 6 sec on and 6 sec off), 28 days as a course of treatment, once a day. |
|
| sham EA | Device | The only difference between sham EA intervention and EA intervention is that the stimulator is connected to the needle handle without power for 40 min intervention. |
|
| Modified Barthel Index (MBI) | Modified Barthel Index (MBI) is a common indicator to evaluate motor function.The maximum total score of Modified Barthel Index is 100, with a higher score meaning less dependent to help. | Modified Barthel Index (MBI) is recorded at baseline (week 0), Mid-term treatment (week 2) and end of treatment (week 4) in all four groups. |
| timed up and go test (TUGT) | timed up and go test (TUGT) is a common indicator to evaluate motor function.In the timed up and go test, each patient is asked to stand up from an armchair at height 45 cm, walk a distance of 3 m, turn, walk back to the chair, and sit back down in chair . With interval of one minute rest, a patient is required to repeat the test three times to take its mean for statistical analysis. | timed up and go test (TUGT) is recorded at baseline (week 0), Mid-term treatment (week 2) and end of treatment (week 4) in all four groups. |
| Tinetti Performance Oriented Mobility Assessment (POMA) | Tinetti Performance Oriented Mobility Assessment (POMA) is a common indicator to evaluate motor function.POMA scale can be used to assess the balance with B-POMA including nine components (sitting balance, arises, attempts to arise, immediate standing balance, standing balance, nudged, eyes closed, turning 360 , and sitting down; maximum 16 points) and to evaluate the gait with G-POMA including seven components (initiation of gait, step length, step symmetry, step continuity, path, trunk, and walking stance; maximum 12 points) . A patient with POMA scored less than 24 points suggets balance dysfunction and scored less than 15 points indicates danger of falling. | Tinetti Performance Oriented Mobility Assessment (POMA) is recorded at baseline (week 0), Mid-term treatment (week 2) and end of treatment (week 4) in all four groups. |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009421 | Nervous System Malformations |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D011115 | Polyneuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D030342 | Genetic Diseases, Inborn |
| D011506 | Proteins |
| D009419 | Nerve Tissue Proteins |
| D001685 | Biological Factors |