Specific Stimulation Mode Electroacupuncture Combined With NGF for Recovery Period of Ischemic Stroke：Protocol for a Randomized Controlled Clinical Trial
Trial Snapshot
- Phase
- Phase 4
- Status
- Recruiting
- Sponsor
- Enrollment
- 288
- Locations
- 1
- Primary Endpoint
- basic cure rate
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 50 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
sham EA + placebo group
sham EA + placebo group contain sham EA intervention and placebo injection
Intervention: Placebo injection (Drug)
sham EA + placebo group
sham EA + placebo group contain sham EA intervention and placebo injection
Intervention: sham EA intervention (Device)
sham EA + NGF group
sham EA + NGF group contain sham EA intervention and NGF injection
Intervention: Nerver growth factor (NGF) injection (Drug)
sham EA + NGF group
sham EA + NGF group contain sham EA intervention and NGF injection
Intervention: sham EA intervention (Device)
EA + placebo group
EA + placebo group contain EA intervention and placebo injection
Intervention: Placebo injection (Drug)
EA + placebo group
EA + placebo group contain EA intervention and placebo injection
Intervention: EA intervention (Device)
EA + NGF group
EA + NGF group contain EA intervention and NGF injection
Intervention: Nerver growth factor (NGF) injection (Drug)
EA + NGF group
EA + NGF group contain EA intervention and NGF injection
Intervention: EA intervention (Device)
Outcomes
Primary Outcomes
basic cure rate
Time Frame: end of treatment (week 4)
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.
Secondary Outcomes
- Montreal Cognitive Assessment (MoCA)(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.)
- 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.)
- 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.)
- Loewenstein Occupational Therapy Cognitive Assessment (LOTCA)(baseline (week 0), Mid-term treatment (week 2) and end of treatment (week 4) in all four groups.)
Investigators
Xianming Lin
Clinical Professor
The Third Affiliated hospital of Zhejiang Chinese Medical University