Effect of Electroacupuncture Combined With NGF on Limb Function in Convalescent Patients With Ischemic Stroke
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- the modified Rankin Score
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •people with first-ever ischemic stroke confirmed by CT or/and MRI;
- •14 days to 6 months after stroke onset;
- •50 years≤aged≤80 years;
- •3≤modified Rankin Score (mRS)≤4;
- •Patients can accept treatment with EA and have good compliance;
- •Patients have clear consciousness, pain perception and resolution ability to complete basic communication;
- •willing to participate and be randomized to one of the groups.
排除标准
- •transient ischemic attack, subarachnoid hemorrhage, cerebral hemorrhage and other cerebrovascular diseases;
- •severe heart, liver, kidney dysfunction and severe coagulation dysfunction; cerebral infarction caused by repeated recurrence of stroke, brain surgery or trauma, and brain tumors;
- •severe neurological deficits before stroke, such as visual and auditory impairment, aphasia, agnosia, severe hemiplegia, or affected limb function before stroke, such as cerebral palsy, polio, fracture, and mRs≥1;
- •diseases with affecting cognitive function such as congenital dementia, or alcohol, drug or substance abuse ;
- •lactation, pregnancy or intend to be pregnant within 6 months;
- •needlesickness, needle phobia and skin infection at acupuncture site;
- •pacemaker, implantable cardioverter defibrillator carriers or conductive metallic foreign bodies in the body;
- •allergy to NGF;
- •currently enrolled in another clinical trial or participation in other clinical trials within the last 3 months.
研究组 & 干预措施
EA + NGF group
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.
干预措施: EA (Device)
sham EA + placebo group
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.
干预措施: physiological saline (Drug)
EA + placebo group
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.
干预措施: EA (Device)
sham EA + NGF group
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.
干预措施: sham EA (Device)
sham EA + placebo group
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.
干预措施: sham EA (Device)
EA + placebo group
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.
干预措施: physiological saline (Drug)
EA + NGF group
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.
干预措施: nerve growth factor (Drug)
sham EA + NGF group
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.
干预措施: nerve growth factor (Drug)
结局指标
主要结局
the modified Rankin Score
时间窗: the end of treatment (week 4) in all four groups.
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.
次要结局
- Modified Barthel Index (MBI)(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.)
- Fugl-Meyer Assessment of motor function score (FMA)(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.)
- timed up and go test (TUGT)(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 recorded at baseline (week 0), Mid-term treatment (week 2) and end of treatment (week 4) in all four groups.)
研究者
Xianming Lin
Clinical Professor
The Third Affiliated hospital of Zhejiang Chinese Medical University