The Impact of Electroacupuncture Combined With NGF on Clinical Effect and Functional Changes on Ischemic Stroke
NCT ID: NCT05231694
Last Updated: 2022-07-28
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE4
288 participants
INTERVENTIONAL
2022-04-01
2025-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effect of EA Combined With NGF on Limb Function in Convalescent Patients With Ischemic Stroke
NCT05652751
Acupuncture Treatment on Motor Dysfunction in Stroke Patients
NCT02975362
Evaluating the Therapeutic Effect of Scalp Acupuncture Treatment for Motor Dysfunction in Ischemic Stroke Patients
NCT02871453
Acupuncture Therapy for Post-stroke Mild Cognitive Impairment: a Randomized Controlled Trial
NCT05924308
A Randomized Controlled Study of the Effectiveness of Scalp Electroacupuncture in Improving Upper Limb Motor Function in Convalescent Phase of Ischemic Stroke.
NCT02850198
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
sham EA + placebo group
sham EA + placebo group contain sham EA intervention and placebo injection
Placebo injection
The patients will receive 1ml volume of physiological saline (PS) injected into the gluteal muscle, once a day for 4 weeks.
sham EA intervention
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.
sham EA + NGF group
sham EA + NGF group contain sham EA intervention and NGF injection
Nerver growth factor (NGF) injection
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.
sham EA intervention
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.
EA + placebo group
EA + placebo group contain EA intervention and placebo injection
Placebo injection
The patients will receive 1ml volume of physiological saline (PS) injected into the gluteal muscle, once a day for 4 weeks.
EA intervention
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.
EA + NGF group
EA + NGF group contain EA intervention and NGF injection
Nerver growth factor (NGF) injection
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.
EA intervention
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Nerver growth factor (NGF) injection
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.
Placebo injection
The patients will receive 1ml volume of physiological saline (PS) injected into the gluteal muscle, once a day for 4 weeks.
EA intervention
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.
sham EA intervention
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 14 days to 6 months after stroke onset;
* 50 years≤aged≤80 years;
* 3≤modified Rankin Score (mRS)≤4, and Mini-Mental State Examinations (MMSE)\<27;
* 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
* 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.
50 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Ningbo No.2 Hospital
OTHER
second people hospital of lishui
UNKNOWN
The Third Affiliated hospital of Zhejiang Chinese Medical University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Xianming Lin
Clinical Professor
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
The Third Affiliated Hospital of Zhejiang Chinese Medical University
Hangzhou, Zhejiang, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Cao Y, Yu S, Zhang Q, Yu T, Liu Y, Sun Z, Zhao M, Wang W, Zhao JZ; Chinese Stroke Association Stroke Council Guideline. Chinese Stroke Association guidelines for clinical management of cerebrovascular disorders: executive summary and 2019 update of clinical management of intracerebral haemorrhage. Stroke Vasc Neurol. 2020 Dec;5(4):396-402. doi: 10.1136/svn-2020-000433. Epub 2020 Dec 1.
Zhao N, Zhang H, Liu T, Liu J, Xiang Y, Shu G, Li C, Xie J, Chen L. Neuromodulatory Effect of Sensorimotor Network Functional Connectivity of Temporal Three-Needle Therapy for Ischemic Stroke Patients with Motor Dysfunction: Study Protocol for a Randomized, Patient-Assessor Blind, Controlled, Neuroimaging Trial. Evid Based Complement Alternat Med. 2021 Jan 4;2021:8820324. doi: 10.1155/2021/8820324. eCollection 2021.
Byun K, Hyodo K, Suwabe K, Ochi G, Sakairi Y, Kato M, Dan I, Soya H. Positive effect of acute mild exercise on executive function via arousal-related prefrontal activations: an fNIRS study. Neuroimage. 2014 Sep;98:336-45. doi: 10.1016/j.neuroimage.2014.04.067. Epub 2014 May 2.
Cope M, Delpy DT. System for long-term measurement of cerebral blood and tissue oxygenation on newborn infants by near infra-red transillumination. Med Biol Eng Comput. 1988 May;26(3):289-94. doi: 10.1007/BF02447083. No abstract available.
Broderick JP, Adeoye O, Elm J. Evolution of the Modified Rankin Scale and Its Use in Future Stroke Trials. Stroke. 2017 Jul;48(7):2007-2012. doi: 10.1161/STROKEAHA.117.017866. Epub 2017 Jun 16. No abstract available.
Fugl-Meyer AR, Jaasko L, Leyman I, Olsson S, Steglind S. The post-stroke hemiplegic patient. 1. a method for evaluation of physical performance. Scand J Rehabil Med. 1975;7(1):13-31.
Son H, Park C. Effect of turning direction on Timed Up and Go test results in stroke patients. Eur J Phys Rehabil Med. 2019 Feb;55(1):35-39. doi: 10.23736/S1973-9087.18.05202-4. Epub 2018 Jul 6.
Chu JJ, Chen XJ, Shen SS, Zhang XF, Chen LY, Zhang JM, He J, Zhao JF. A poor performance in comprehensive geriatric assessment is associated with increased fall risk in elders with hypertension: a cross-sectional study. J Geriatr Cardiol. 2015 Mar;12(2):113-8. doi: 10.11909/j.issn.1671-5411.2015.02.006.
Zhao W, You H, Jiang S, Zhang H, Yang Y, Zhang M. Effect of Pro-kin visual feedback balance training system on gait stability in patients with cerebral small vessel disease. Medicine (Baltimore). 2019 Feb;98(7):e14503. doi: 10.1097/MD.0000000000014503.
Huang J, Lin Z, Wang Q, Liu F, Liu J, Fang Y, Chen S, Zhou X, Hong W, Wu J, Madrigal-Mora N, Zheng G, Yang S, Tao J, Chen L. The effect of a therapeutic regimen of Traditional Chinese Medicine rehabilitation for post-stroke cognitive impairment: study protocol for a randomized controlled trial. Trials. 2015 Jun 16;16:272. doi: 10.1186/s13063-015-0795-x.
Larsson AC, Palstam A, Persson HC. Physical Function, Cognitive Function, and Daily Activities in Patients Hospitalized Due to COVID-19: A Descriptive Cross-Sectional Study in Sweden. Int J Environ Res Public Health. 2021 Nov 4;18(21):11600. doi: 10.3390/ijerph182111600.
Lu H, Zhang T, Wen M, Sun L. Impact of repetitive transcranial magnetic stimulation on post-stroke dysmnesia and the role of BDNF Val66Met SNP. Med Sci Monit. 2015 Mar 14;21:761-8. doi: 10.12659/MSM.892337.
Cai Y, Zhang CS, Ouyang W, Li J, Nong W, Zhang AL, Xue CC, Wen Z. Electroacupuncture for poststroke spasticity (EAPSS): protocol for a randomised controlled trial. BMJ Open. 2018 Feb 27;8(2):e017912. doi: 10.1136/bmjopen-2017-017912.
Yu KW, Lin CL, Hung CC, Chou EC, Hsieh YL, Li TM, Chou LW. Effects of electroacupuncture on recent stroke inpatients with incomplete bladder emptying: a preliminary study. Clin Interv Aging. 2012;7:469-74. doi: 10.2147/CIA.S37531. Epub 2012 Nov 8.
Baber N. International conference on harmonisation of technical requirements for registration of pharmaceuticals for human use (ICH). Br J Clin Pharmacol. 1994 May;37(5):401-4. doi: 10.1111/j.1365-2125.1994.tb05705.x. No abstract available.
Zhen X, Sun X, Dong H. Health Technology Assessment and Its Use in Drug Policies in China. Value Health Reg Issues. 2018 May;15:138-148. doi: 10.1016/j.vhri.2018.01.010. Epub 2018 May 3.
Dai M, Zhao Y, Jia Z, Xu S, Xu N, Wu X, Liu J, Wu L, Yu K, Lin X. Effect of Specific mode electroacupuncture stimulation combined with NGF during the ischaemic stroke: Study protocol for a randomized controlled trial. Clinics (Sao Paulo). 2024 Jul 20;79:100451. doi: 10.1016/j.clinsp.2024.100451. eCollection 2024.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
XLin
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.