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Ischemic stroke is a common clinical disease, often accompanied by dysphagia. At present, clinical treatment for patients with dysphagia after ischemic stroke is limited. The emergence of NGF has surprised the field of neurorehabilitation, but the clinical effect is not satisfactory. The main problem is that NGF is a macromolecular material with a molecular weight of 13.4 KD, which is difficult to penetrate the blood brain barrier. A large number of previous studies in our team have found that electroacupuncture with specific stimulation mode can open the blood brain barrier and induce NGF into the brain. Therefore, the purpose of this study is to investigate the effect of specific mode electroacupuncture stimulation combined with NGF treatment on patients with dysphagia after ischemic stroke and to explore the mechanism of this combination therapy to improve brain function, which creates a new method and theoretical basis for nerve rehabilitation of integrated traditional Chinese and Western medicine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EA + NGF group | Experimental |
| |
| EA + placebo group | Placebo Comparator |
| |
| Acupuncture + NGF group | Sham Comparator |
| |
| Acupuncture + placebo group | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nerver growth factor (NGF) injection | Drug | The 20ug mouse nerve growth factor (NO. S20060051, Jinlujie) will be obtained from Hiteck Biopharmaceutical Co., Ltd., Wuhan, China. mNGF will be dissolved in 2 ml of sterile water for injection and then injected intramuscularly into the gluteal muscle, three times a week for 6 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Functional Oral Intake Scale (FOIS) | week 0, week 2, week 4, week 6, week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Dysphagia Outcome and Severity Scale (DOSS) | week 0, week 6 | |
| Penetration Aspiration Scale (PAS) | week 0, week 6 | |
| modified Rankin Scale (mRS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xianming Lin, PHD | Contact | +86-13858028101 | linxianming1966@163.com | |
| Xiaoyang Yu | Contact | +86-13820732817 | xiaoyangyu@zcmu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Third Affiliated Hospital of Zhejiang Chinese Medical University | Recruiting | Hangzhou | Zhejiang | 310005 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38027487 | Background | Fu X, Li H, Yang W, Li X, Lu L, Guo H, Guo K, Huang Z. Electroacupuncture at HT5 + GB20 promotes brain remodeling and significantly improves swallowing function in patients with stroke. Front Neurosci. 2023 Nov 2;17:1274419. doi: 10.3389/fnins.2023.1274419. eCollection 2023. | |
| 38995444 | Background | Dai M, Qian K, Ye Q, Yang J, Gan L, Jia Z, Pan Z, Cai Q, Jiang T, Ma C, Lin X. Specific Mode Electroacupuncture Stimulation Mediates the Delivery of NGF Across the Hippocampus Blood-Brain Barrier Through p65-VEGFA-TJs to Improve the Cognitive Function of MCAO/R Convalescent Rats. Mol Neurobiol. 2025 Feb;62(2):1451-1466. doi: 10.1007/s12035-024-04337-8. Epub 2024 Jul 12. |
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The data and results of this study need to be confirmed by Xianming Lin.
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|
| Placebo injection | Drug | Patients will receive 2ml volume of physiological saline (PS) injected intramuscularly into the gluteal muscle, three times a week for 6 weeks. |
|
| EA intervention | Device | Patients take supine position. After skin disinfection with 75% ethanol routine disinfection, the stainless needle (size 0.25mm×40mm, Hwato 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 Jisheng, Ltd., China) with a frequency of 2/100 Hz and an intensity of patient can tolerate, targeting a current strength of 3.0mA, for 40 min (a homemade relay cycled power to the electrode for 6 sec on and 6 sec off), three times a week for 6 weeks. |
|
| Acupuncture intervention | Device | Patients take supine position. After skin disinfection with 75% ethanol routine disinfection, the stainless needle (size 0.25mm×40mm, Hwato 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 connected to an acupuncture point nerve stimulator (HANS-200, Nanjing Jisheng, Ltd., China) without closed circuit, 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), three times a week for 6 weeks. |
|
| week 0, week 2, week 4, week 6 |
| Modified Barthel Index (MBI) | week 0, week 2, week 4, week 6 |
| Oxygenated hemoglobin and deoxygenated hemoglobin in cerebral cortex | Measure method: fNIRS | week 0, week 6 |
| 37942738 | Background | Lin Y, Gan L, Ren L, Ma C, Dai M, Qian K, Ye Q, Lin X. Acupuncture with specific mode electro-stimulation effectively and transiently opens the BBB through Shh signaling pathway. Neuroreport. 2023 Dec 13;34(18):873-886. doi: 10.1097/WNR.0000000000001970. Epub 2023 Nov 8. |
| 33132703 | Background | Sheng L, Yin L, Peng D, Zhao L. From Best Evidence to Best Practice: Enteral Nutrition from Continuous Nasal Feeding in Stroke Patients. Int J Gen Med. 2020 Oct 22;13:927-936. doi: 10.2147/IJGM.S269393. eCollection 2020. |
| 28645333 | Background | Zhang H, Park JH, Maharjan S, Park JA, Choi KS, Park H, Jeong Y, Ahn JH, Kim IH, Lee JC, Cho JH, Lee IK, Lee CH, Hwang IK, Kim YM, Suh YG, Won MH, Kwon YG. Sac-1004, a vascular leakage blocker, reduces cerebral ischemia-reperfusion injury by suppressing blood-brain barrier disruption and inflammation. J Neuroinflammation. 2017 Jun 23;14(1):122. doi: 10.1186/s12974-017-0897-3. |
| 22452968 | Background | Gutierrez-Fernandez M, Fuentes B, Rodriguez-Frutos B, Ramos-Cejudo J, Vallejo-Cremades MT, Diez-Tejedor E. Trophic factors and cell therapy to stimulate brain repair after ischaemic stroke. J Cell Mol Med. 2012 Oct;16(10):2280-90. doi: 10.1111/j.1582-4934.2012.01575.x. |
| 26410746 | Background | Barbero P, Busso M, Tinivella M, Artusi CA, De Mercanti S, Cucci A, Veltri A, Avagnina P, Calvo A, Chio' A, Durelli L, Clerico M. Long-term follow-up of ultrasound-guided botulinum toxin-A injections for sialorrhea in neurological dysphagia. J Neurol. 2015 Dec;262(12):2662-7. doi: 10.1007/s00415-015-7894-1. Epub 2015 Sep 26. |
| 29573064 | Background | Rofes L, Muriana D, Palomeras E, Vilardell N, Palomera E, Alvarez-Berdugo D, Casado V, Clave P. Prevalence, risk factors and complications of oropharyngeal dysphagia in stroke patients: A cohort study. Neurogastroenterol Motil. 2018 Mar 23:e13338. doi: 10.1111/nmo.13338. Online ahead of print. |
| 37596008 | Background | Labeit B, Michou E, Hamdy S, Trapl-Grundschober M, Suntrup-Krueger S, Muhle P, Bath PM, Dziewas R. The assessment of dysphagia after stroke: state of the art and future directions. Lancet Neurol. 2023 Sep;22(9):858-870. doi: 10.1016/S1474-4422(23)00153-9. |
| 41929605 | Derived | Yu X, Xuan Z, Jia Z, Niu X, Yan Y, Zhang Y, Lin L, Li J, Ma C, Lin X. Effect of specific mode electroacupuncture stimulation combined with NGF on dysphagia after ischemic stroke: study protocol for a pilot randomized controlled trial. Front Neurol. 2026 Mar 18;17:1697292. doi: 10.3389/fneur.2026.1697292. eCollection 2026. |
| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D003680 | Deglutition Disorders |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010608 | Pharyngeal Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| D020932 | Nerve Growth Factor |
| D007267 | Injections |
| ID | Term |
|---|---|
| D009414 | Nerve Growth Factors |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D009419 | Nerve Tissue Proteins |
| D001685 | Biological Factors |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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