Effect of Specific Mode Electroacupuncture Stimulation Combined with NGF on Dysphagia After Ischaemic Stroke: a Pilot Randomized Controlled Trial
NCT ID: NCT06737549
Last Updated: 2024-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
144 participants
INTERVENTIONAL
2024-12-31
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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EA + NGF group
Nerver growth factor (NGF) injection
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.
EA intervention
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.
EA + placebo group
Placebo injection
Patients will receive 2ml volume of physiological saline (PS) injected intramuscularly into the gluteal muscle, three times a week for 6 weeks.
EA intervention
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 + NGF group
Nerver growth factor (NGF) injection
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.
Acupuncture intervention
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.
Acupuncture + placebo group
Placebo injection
Patients will receive 2ml volume of physiological saline (PS) injected intramuscularly into the gluteal muscle, three times a week for 6 weeks.
Acupuncture intervention
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.
Interventions
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Nerver growth factor (NGF) injection
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.
Placebo injection
Patients will receive 2ml volume of physiological saline (PS) injected intramuscularly into the gluteal muscle, three times a week for 6 weeks.
EA intervention
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
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.
Eligibility Criteria
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Inclusion Criteria
2. Onset time ranged from 15 days to 180 days;
3. Aged 18 to 80 years old, male or female;
4. Dysphagia confirmed by a videofluoroscopic swallowing study (VFSS);
5. Patients who are able to accept and comply with acupuncture, electroacupuncture treatment, gluteal intramuscular injection, and have good compliance;
6. Have provided signed consent and exhibit willingness to participate in the trial.
7. Women who are lactating, pregnant or intending to get pregnant;
Exclusion Criteria
2. Patients with severe cognitive impairment;
3. Patients with severe cardiac, hepatic, and renal dysfunction, as well as severe coagulation abnormalities;
4. Patients with other abnormal test results who are deemed unsuitable to participate in this study by the investigator.
5. Multiple occurrences of stroke, or a history of craniocerebral surgery, or cerebral infarction caused by trauma or brain tumors.
6. Patients with severe neurological deficits prior to ischemic stroke, such as visual and auditory impairments, aphasia, agnosia, severe hemiplegia, and other conditions.
7. Women who are lactating, pregnant or intending to get pregnant;
8. Patients with a history of needle fainting or with skin infections at the acupuncture site.
9. Cardiac pacemaker carrier;
10. Patients allergic to NGF;
11. The inability to undergo VFSS;
12. Patients with a medication history that may alter cortical excitability within the past 2 months.
13. Patients who are currently participating in other clinical trials or have participated in clinical trials that ended within the last 3 months.
18 Years
80 Years
ALL
No
Sponsors
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The Third Affiliated hospital of Zhejiang Chinese Medical University
OTHER
Responsible Party
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Xianming Lin
PHD
Locations
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The Third Affiliated Hospital of Zhejiang Chinese Medical University
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Xianming Lin, PHD
Role: primary
References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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ZSLL-KY-2024-074-01
Identifier Type: -
Identifier Source: org_study_id