Back to resultsThe Impact of Electroacupuncture Combined With NGF on Clinical Effect and Functional Changes on Ischemic Stroke
Primary Purpose
Ischemic Stroke
Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Nerver growth factor (NGF) injection
Placebo injection
EA intervention
sham EA intervention
Sponsored by
About this trial
This is an interventional treatment trial for Ischemic Stroke focused on measuring ischemic stroke, Convalescence, Electroacupuncture, nerve growth factor
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.
Sites / Locations
- The Third Affiliated Hospital of Zhejiang Chinese Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Other
Other
Other
Other
Arm Label
sham EA + placebo group
sham EA + NGF group
EA + placebo group
EA + NGF group
Arm Description
sham EA + placebo group contain sham EA intervention and placebo injection
sham EA + NGF group contain sham EA intervention and NGF injection
EA + placebo group contain EA intervention and placebo injection
EA + NGF group contain EA intervention and NGF injection
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
simplified Fugl-Meyer Assessment of motor function score (FMA)
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
Modified Barthel Index (MBI)
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.
timed up and go test (TUGT)
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)
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.
Montreal Cognitive Assessment (MoCA)
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.
Loewenstein Occupational Therapy Cognitive Assessment (LOTCA)
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.
Full Information
NCT ID
NCT05231694
First Posted
January 30, 2022
Last Updated
July 26, 2022
Sponsor
The Third Affiliated hospital of Zhejiang Chinese Medical University
Collaborators
Ningbo No.2 Hospital, second people hospital of lishui
1. Study Identification
Unique Protocol Identification Number
NCT05231694
Brief Title
The Impact of Electroacupuncture Combined With NGF on Clinical Effect and Functional Changes on Ischemic Stroke
Official Title
Specific Stimulation Mode Electroacupuncture Combined With NGF for Recovery Period of Ischemic Stroke：Protocol for a Randomized Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
September 30, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Third Affiliated hospital of Zhejiang Chinese Medical University
Collaborators
Ningbo No.2 Hospital, second people hospital of lishui
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke
Keywords
ischemic stroke, Convalescence, Electroacupuncture, nerve growth factor
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
288 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
sham EA + placebo group
Arm Type
Other
Arm Description
sham EA + placebo group contain sham EA intervention and placebo injection
Arm Title
sham EA + NGF group
Arm Type
Other
Arm Description
sham EA + NGF group contain sham EA intervention and NGF injection
Arm Title
EA + placebo group
Arm Type
Other
Arm Description
EA + placebo group contain EA intervention and placebo injection
Arm Title
EA + NGF group
Arm Type
Other
Arm Description
EA + NGF group contain EA intervention and NGF injection
Intervention Type
Drug
Intervention Name(s)
Nerver growth factor (NGF) injection
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo injection
Intervention Description
The patients will receive 1ml volume of physiological saline (PS) injected into the gluteal muscle, once a day for 4 weeks.
Intervention Type
Device
Intervention Name(s)
EA intervention
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
sham EA intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
basic cure rate
Description
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.
Time Frame
end of treatment (week 4)
Secondary Outcome Measure Information:
Title
simplified Fugl-Meyer Assessment of motor function score (FMA)
Description
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
Time Frame
baseline (week 0), Mid-term treatment (week 2) and end of treatment (week 4) in all four groups.
Title
Modified Barthel Index (MBI)
Description
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.
Time Frame
baseline (week 0), Mid-term treatment (week 2) and end of treatment (week 4) in all four groups.
Title
timed up and go test (TUGT)
Description
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
Time Frame
baseline (week 0), Mid-term treatment (week 2) and end of treatment (week 4) in all four groups.
Title
Tinetti Performance Oriented Mobility Assessment (POMA)
Description
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.
Time Frame
baseline (week 0), Mid-term treatment (week 2) and end of treatment (week 4) in all four groups.
Title
Montreal Cognitive Assessment (MoCA)
Description
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.
Time Frame
baseline (week 0), Mid-term treatment (week 2) and end of treatment (week 4) in all four groups.
Title
Loewenstein Occupational Therapy Cognitive Assessment (LOTCA)
Description
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.
Time Frame
baseline (week 0), Mid-term treatment (week 2) and end of treatment (week 4) in all four groups.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
xianming Lin, PHD
Phone
+86-13858028101
Email
linxianming1966@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
yibin Zhao, PHD
Phone
+86-15757195003
Email
510496772@qq.com
Facility Information:
Facility Name
The Third Affiliated Hospital of Zhejiang Chinese Medical University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xianming Lin, PHD
Email
linxianming1966@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
The data and results of this study need to be confirmed by Lin Xianming
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The Impact of Electroacupuncture Combined With NGF on Clinical Effect and Functional Changes on Ischemic Stroke
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