Clinical trial NCT05231694: The Impact of Electroacupuncture Combined With NGF on Clinical Effect and Functional Changes on Ischemic Stroke
Official title: Specific Stimulation Mode Electroacupuncture Combined With NGF for Recovery Period of Ischemic Stroke：Protocol for a Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Ischemic Stroke
Keywords: ischemic stroke
Convalescence
Electroacupuncture
nerve growth factor
Lead sponsor: The Third Affiliated hospital of Zhejiang Chinese Medical University
Sponsor class: OTHER
Collaborators: name: Ningbo No.2 Hospital
name: second people hospital of lishui
First posted: 2022-02-09
Enrollment: 288
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Ischemic stroke is a common clinical disease, often accompanied by motor dysfunction and cognitive impairment. At present, clinical treatment for patients with ischemic stroke recovery is limited and ineffective. 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 stimulation mode electroacupuncture combined with NGF treatment together with rehabilitation training on patients with ischemic stroke recovery period 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.


Eligibility criteria: 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, 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:

* 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.

Primary outcomes:
measure: basic cure rate
timeFrame: end of treatment (week 4)
Secondary outcomes:
measure: simplified Fugl-Meyer Assessment of motor function score (FMA)
timeFrame: baseline (week 0), Mid-term treatment (week 2) and end of treatment (week 4) in all four groups.
measure: Modified Barthel Index (MBI)
timeFrame: baseline (week 0), Mid-term treatment (week 2) and end of treatment (week 4) in all four groups.
measure: timed up and go test (TUGT)
timeFrame: baseline (week 0), Mid-term treatment (week 2) and end of treatment (week 4) in all four groups.
measure: Tinetti Performance Oriented Mobility Assessment (POMA)
timeFrame: baseline (week 0), Mid-term treatment (week 2) and end of treatment (week 4) in all four groups.
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: baseline (week 0), Mid-term treatment (week 2) and end of treatment (week 4) in all four groups.
measure: Loewenstein Occupational Therapy Cognitive Assessment (LOTCA)
timeFrame: baseline (week 0), Mid-term treatment (week 2) and end of treatment (week 4) in all four groups.
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The Third Affiliated Hospital of Zhejiang Chinese Medical University
state: Zhejiang
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.