The Impact of Electroacupuncture Combined With NGF on Clinical Effect and Functional Changes on Ischemic Stroke

NCT05231694 | Unknown Phase 4

• 1 other identifier: XLin
• Study Type: interventional
• Target: 288
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemic Stroke

Keywords

ischemic stroke; Convalescence; Electroacupuncture; nerve growth factor

Outcome Measures

Primary Outcomes (1)

• basic cure rate

  patients with the modified Rankin Score ≤ 2 are judged as basic cure, and basic cure rate= number of patients with the modified Rankin Score ≤ 2 / group \* 100 %. The modified Rankin Score ranges from 0 to 6, and the more severe the neurological deficit, the higher the score. at the end of treatment, the modified Rankin Score is recorded in all four groups.

  end of treatment (week 4)

Secondary Outcomes (6)

• simplified Fugl-Meyer Assessment of motor function score (FMA)

  baseline (week 0), Mid-term treatment (week 2) and end of treatment (week 4) in all four groups.

• Modified Barthel Index (MBI)

  baseline (week 0), Mid-term treatment (week 2) and end of treatment (week 4) in all four groups.

• timed up and go test (TUGT)

  baseline (week 0), Mid-term treatment (week 2) and end of treatment (week 4) in all four groups.

• Tinetti Performance Oriented Mobility Assessment (POMA)

  baseline (week 0), Mid-term treatment (week 2) and end of treatment (week 4) in all four groups.

• Montreal Cognitive Assessment (MoCA)

  baseline (week 0), Mid-term treatment (week 2) and end of treatment (week 4) in all four groups.

Study Arms (4)

sham EA + placebo group

OTHER

sham EA + placebo group contain sham EA intervention and placebo injection

Drug: Placebo injection; Device: sham EA intervention

sham EA + NGF group

OTHER

sham EA + NGF group contain sham EA intervention and NGF injection

Drug: Nerver growth factor (NGF) injection; Device: sham EA intervention

EA + placebo group

OTHER

EA + placebo group contain EA intervention and placebo injection

Drug: Placebo injection; Device: EA intervention

EA + NGF group

OTHER

EA + NGF group contain EA intervention and NGF injection

Drug: Nerver growth factor (NGF) injection; Device: EA intervention

Interventions

Nerver growth factor (NGF) injection DRUG

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 + NGF group; sham EA + NGF group

Placebo injection DRUG

The patients will receive 1ml volume of physiological saline (PS) injected into the gluteal muscle, once a day for 4 weeks.

EA + placebo group; sham EA + placebo group

EA intervention DEVICE

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 + placebo group

sham EA intervention DEVICE

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 + placebo group

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• people with first-ever ischemic stroke confirmed by CT or/and MRI;
• days to 6 months after stroke onset;
• years≤aged≤80 years;
• ≤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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Third Affiliated hospital of Zhejiang Chinese Medical University: lead
• Ningbo No.2 Hospital: collaborator
• second people hospital of lishui: collaborator

Study Sites (1)

The Third Affiliated Hospital of Zhejiang Chinese Medical University

Hangzhou, Zhejiang, 310000, China

RECRUITING

Related Publications (17)

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• 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.

  PMID: 39033586 DERIVED

MeSH Terms

Conditions

Ischemic Stroke; Convalescence; Hereditary Sensory and Autonomic Neuropathies

Interventions

Nerve Growth Factor; Injections

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nervous System Malformations; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn

Intervention Hierarchy (Ancestors)

Nerve Growth Factors; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Nerve Tissue Proteins; Biological Factors; Drug Administration Routes; Drug Therapy; Therapeutics

Central Study Contacts

xianming Lin, PHD

CONTACT

+86-13858028101; linxianming1966@163.com

yibin Zhao, PHD

CONTACT

+86-15757195003; 510496772@qq.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: January 30, 2022
• First Posted: February 9, 2022
• Study Start: April 1, 2022
• Primary Completion: September 30, 2025
• Study Completion: December 31, 2025
• Last Updated: July 28, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)