NCT05652751

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: The Third Affiliated hospital of Zhejiang Chinese Medical University · Academic / Other
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Ischemic Stroke

Interventions

Type	Name	Description
DRUG	nerve growth factor	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.
DRUG	physiological saline	Other patients will receive 1ml volume of physiological saline (PS) injected into the gluteal muscle, once a day for 4 weeks.
DEVICE	EA	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.
DEVICE	sham EA	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.

Timeline

• Start date: 2022-03-01
• Primary completion: 2023-02-01
• Completion: 2023-06-01
• First posted: 2022-12-15
• Last updated: 2022-12-15

Locations

1 site across 1 country: China