Effect of EA Combined With NGF on Limb Function in Convalescent Patients With Ischemic Stroke

The Third Affiliated hospital of Zhejiang Chinese Medical University

Status: Enrolling

Conditions: Ischemic Stroke

Treatments: Device: sham EA; Drug: nerve growth factor; Drug: physiological saline; Device: EA

Study type: Interventional

Funder types: Other

Identifiers

NCT05652751

Yibinzhao

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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120 participants in 4 patient groups, including a placebo group

sham EA + placebo group

Placebo Comparator group

Description:

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.

Treatment:

Device: sham EA

Drug: physiological saline

EA + placebo group

Active Comparator group

Description:

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.

Treatment:

Device: EA

Drug: physiological saline

sham EA + NGF group

Active Comparator group

Description:

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.

Treatment:

Device: sham EA

Drug: nerve growth factor

EA + NGF group

Active Comparator group

Description:

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.

Treatment:

Device: EA

Drug: nerve growth factor