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

The Third Affiliated hospital of Zhejiang Chinese Medical University

Status and phase: Enrolling; Phase 4

Conditions: Ischemic Stroke

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05231694

XLin (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 288 estimated patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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288 participants in 4 patient groups

sham EA + placebo group

Other group

Description:

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

Treatment:

Device: sham EA intervention

Drug: Placebo injection

sham EA + NGF group

Other group

Description:

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

Treatment:

Device: sham EA intervention

Drug: Nerver growth factor (NGF) injection

EA + placebo group

Other group

Description:

EA + placebo group contain EA intervention and placebo injection

Treatment:

Drug: Placebo injection

Device: EA intervention

EA + NGF group

Other group

Description:

EA + NGF group contain EA intervention and NGF injection

Treatment:

Drug: Nerver growth factor (NGF) injection

Device: EA intervention