Combining electroacupuncture and nerve growth factor for recovery from ischemic stroke

Specific Stimulation Mode Electroacupuncture Combined With NGF for Recovery Period of Ischemic Stroke：Protocol for a Randomized Controlled Clinical Trial

This study is testing if combining electroacupuncture with a nerve growth factor treatment can help people recovering from an ischemic stroke improve their brain function and rehabilitation results.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 288 (estimated)
• Ages: 50 Years to 80 Years
• Sex: All
• Sponsor: The Third Affiliated hospital of Zhejiang Chinese Medical University (Academic / other)
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT05231694 on ClinicalTrials.gov

What this trial studies

This study investigates the effects of electroacupuncture combined with nerve growth factor (NGF) treatment on patients recovering from ischemic stroke. The approach aims to enhance the delivery of NGF across the blood-brain barrier using specific electroacupuncture techniques, potentially improving brain function and rehabilitation outcomes. Participants will receive either NGF or placebo injections alongside rehabilitation training, with the goal of assessing clinical effects and functional changes during the recovery period. The study focuses on patients who are within 14 days to 6 months post-stroke and have specific eligibility criteria.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 50 to 80 who have experienced their first ischemic stroke within the last 14 days to 6 months and meet specific neurological assessment criteria.

Not a fit: Patients with severe pre-existing neurological deficits or other significant cerebrovascular diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve recovery outcomes for patients with ischemic stroke.

How similar studies have performed: Previous studies have shown promise in using electroacupuncture for neurological recovery, but this specific combination with NGF is relatively novel.

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.

Where this trial is running

Hangzhou, Zhejiang

• The Third Affiliated Hospital of Zhejiang Chinese Medical University — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Study coordinator: xianming Lin, PHD

Conditions Ischemic Stroke; ischemic stroke; Convalescence; Electroacupuncture; nerve growth factor