The Impact of Electroacupuncture Combined With NGF on Clinical Effect and Functional Changes on Ischemic Stroke
- Conditions
- Ischemic Stroke
- Interventions
- Drug: Placebo injectionDrug: Nerver growth factor (NGF) injectionDevice: sham EA interventionDevice: EA intervention
- Registration Number
- NCT05231694
- Lead Sponsor
- The Third Affiliated hospital of Zhejiang Chinese Medical University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 288
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description sham EA + placebo group Placebo injection sham EA + placebo group contain sham EA intervention and placebo injection sham EA + placebo group sham EA intervention sham EA + placebo group contain sham EA intervention and placebo injection sham EA + NGF group Nerver growth factor (NGF) injection sham EA + NGF group contain sham EA intervention and NGF injection sham EA + NGF group sham EA intervention sham EA + NGF group contain sham EA intervention and NGF injection EA + placebo group Placebo injection EA + placebo group contain EA intervention and placebo injection EA + placebo group EA intervention EA + placebo group contain EA intervention and placebo injection EA + NGF group Nerver growth factor (NGF) injection EA + NGF group contain EA intervention and NGF injection EA + NGF group EA intervention EA + NGF group contain EA intervention and NGF injection
- Primary Outcome Measures
Name Time Method basic cure rate 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 Outcome Measures
Name Time Method Montreal Cognitive Assessment (MoCA) baseline (week 0), Mid-term treatment (week 2) and end of treatment (week 4) in all four groups. The Montreal Cognitive Assessment is a 30-point test and focuses on assessing seven cognitive domains including visual-spatial and executive abilities, naming, delayed memory recall, attention, abstraction, language and orientation functions . A patient with MoCA scored less than 26 points suggets cognitive impairment.
Modified Barthel Index (MBI) baseline (week 0), Mid-term treatment (week 2) and end of treatment (week 4) in all four groups. Modified Barthel Index is one of the measures to evaluate activities of daily living and consisted of 10 items (bathing, personal hygiene, feeding, dressing, toilet use, bladder continence, bowel control, stair climbing, chair/bed transfers and mobility. Besides, wheelchair score only if patient is unable to ambulate and is trained in wheelchair managemen). The maximum total score of Modified Barthel Index is 100, with a higher score meaning less dependent to help.
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. simplified Fugl-Meyer Assessment of motor function score sums up a total score (maximum 100 points ), including an assessment of the upper extremity (maximum 66 points) and lower extremity (maximum 34 points). Improvement in simplified Fugl-Meyer Assessment of motor function score suggests the recovery of motor function
timed up and go test (TUGT) baseline (week 0), Mid-term treatment (week 2) and end of treatment (week 4) in all four groups. timed up and go test is an assessment tool for measuring mobility in stroke patients. In the timed up and go test, each patient is asked to stand up from an armchair at height 45 cm, walk a distance of 3 m, turn, walk back to the chair, and sit back down in chair . With interval of one minute rest, a patient is required to repeat the test three times to take its mean for statistical analysis
Tinetti Performance Oriented Mobility Assessment (POMA) baseline (week 0), Mid-term treatment (week 2) and end of treatment (week 4) in all four groups. POMA scale can be used to assess the balance with B-POMA including nine components (sitting balance, arises, attempts to arise, immediate standing balance, standing balance, nudged, eyes closed, turning 360 , and sitting down; maximum 16 points) and to evaluate the gait with G-POMA including seven components (initiation of gait, step length, step symmetry, step continuity, path, trunk, and walking stance; maximum 12 points) . A patient with POMA scored less than 24 points suggets balance dysfunction and scored less than 15 points indicates danger of falling.
Loewenstein Occupational Therapy Cognitive Assessment (LOTCA) baseline (week 0), Mid-term treatment (week 2) and end of treatment (week 4) in all four groups. Loewenstein Occupational Therapy Cognitive Assessment is a 91-point test to estimate cognitive functions including orientation (8 points), perception (24 points), visual movement organization (28 points), thought operation (27 points), attention and concentration (4 points). The higher the score of patients indicates the better the cognitive function.
Trial Locations
- Locations (1)
The Third Affiliated Hospital of Zhejiang Chinese Medical University
🇨🇳Hangzhou, Zhejiang, China