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Effect of EA Combined With NGF on Limb Function in Convalescent Patients With Ischemic Stroke

Primary Purpose

Ischemic Stroke

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
nerve growth factor
physiological saline
EA
sham EA
Sponsored by
The Third Affiliated hospital of Zhejiang Chinese Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemic Stroke focused on measuring Convalescence, Electroacupuncture, nerve growth factor

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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; 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

Placebo Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

sham EA + placebo group

EA + placebo group

sham EA + NGF group

EA + NGF group

Arm Description

The sham EA intervention a is that the stimulator is connected to the needle handle on GV20 and GV26 without power for 40 min intervention,once a day for 4 weeks;The patients will receive 1ml volume of physiological saline (PS) injected into the gluteal muscle, once a day for 4 weeks before the sham EA intervention.

Patients take supine position. After skin disinfection with 75% ethanol routine disinfection, the stainless needle will be inserted in GV20（Baihui) and the stainless needle 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;The patients will receive 1ml volume of physiological saline (PS) injected into the gluteal muscle, once a day for 4 weeks before the EA intervention.

The sham EA intervention a is that the stimulator is connected to the needle handle on GV20 and GV26 without power for 40 min intervention,once a day for 4 weeks;The 20ug nerve growth factor 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 before the sham EA intervention. Dose modification is not allowed for mNGF.

Patients take supine position. After skin disinfection with 75% ethanol routine disinfection, the stainless needle will be inserted in GV20（Baihui) and the stainless needle will be inserted in GV26 (Shuigou), acupoints will be stimulated manually until patients feel soreness, distension or heaviness . Then, the needles are stimulated by using an acupuncture point nerve stimulator , 28 days as a course of treatment, once a day;The 20ug nerve growth factor will be dissolved in 1 ml sterile water for injection and then injected intramuscularly at gluteal muscle, once a day for 4 weeks before the EA intervention. Dose modification is not allowed for mNGF.

Outcomes

Primary Outcome Measures

the modified Rankin Score
the modified Rankin Score is a common indicator to evaluate motor function in stroke patients.The modified Rankin Score ranges from 0 to 6, and the more severe the neurological deficit, the higher the score.

Secondary Outcome Measures

Fugl-Meyer Assessment of motor function score (FMA)
Fugl-Meyer Assessment of motor function score (FMA) is a common indicator to evaluate motor function.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).
Modified Barthel Index (MBI)
Modified Barthel Index (MBI) is a common indicator to evaluate motor function.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 (TUGT) is a common indicator to evaluate motor function.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)
Tinetti Performance Oriented Mobility Assessment (POMA) is a common indicator to evaluate motor function.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.

Full Information

First Posted
November 30, 2022
Last Updated
December 14, 2022
Sponsor
The Third Affiliated hospital of Zhejiang Chinese Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05652751
Brief Title
Effect of EA Combined With NGF on Limb Function in Convalescent Patients With Ischemic Stroke
Official Title
Effect of Electroacupuncture Combined With NGF on Limb Function in Convalescent Patients With Ischemic Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
February 1, 2023 (Anticipated)
Study Completion Date
June 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Third Affiliated hospital of Zhejiang Chinese Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Most ischemic stroke patients are in recovery phase, often accompanied by motor impairment, but they lack effective treatment. The appearance of nerve growth factor (NGF) promotes the development of neuroprotective therapy, but it has little effect on stroke because of the blood-brain barrier (BBB). Electroacupuncture (EA) has been used for stroke, while there is no significant clinical effect for recovery phrase. Consequently, we will conduct a multicentre, randomised, controlled, assessor-blinded clinical trial to assess the effectiveness and safety of EA combined with NGF treatment on ischemic stroke recovery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke
Keywords
Convalescence, Electroacupuncture, nerve growth factor

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
people who are14 days to 6 months after stroke onset
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
In this trail, it's difficult to blind researchers, because they perform sham EA or EA, and inject NGF or placebo on patients. However, patients, independent outcome assessors and independent statisticians will be blinded to group allocation throughout the entire trial.
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
sham EA + placebo group
Arm Type
Placebo Comparator
Arm Description
The sham EA intervention a is that the stimulator is connected to the needle handle on GV20 and GV26 without power for 40 min intervention,once a day for 4 weeks;The patients will receive 1ml volume of physiological saline (PS) injected into the gluteal muscle, once a day for 4 weeks before the sham EA intervention.
Arm Title
EA + placebo group
Arm Type
Active Comparator
Arm Description
Patients take supine position. After skin disinfection with 75% ethanol routine disinfection, the stainless needle will be inserted in GV20（Baihui) and the stainless needle 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;The patients will receive 1ml volume of physiological saline (PS) injected into the gluteal muscle, once a day for 4 weeks before the EA intervention.
Arm Title
sham EA + NGF group
Arm Type
Active Comparator
Arm Description
The sham EA intervention a is that the stimulator is connected to the needle handle on GV20 and GV26 without power for 40 min intervention,once a day for 4 weeks;The 20ug nerve growth factor 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 before the sham EA intervention. Dose modification is not allowed for mNGF.
Arm Title
EA + NGF group
Arm Type
Active Comparator
Arm Description
Patients take supine position. After skin disinfection with 75% ethanol routine disinfection, the stainless needle will be inserted in GV20（Baihui) and the stainless needle will be inserted in GV26 (Shuigou), acupoints will be stimulated manually until patients feel soreness, distension or heaviness . Then, the needles are stimulated by using an acupuncture point nerve stimulator , 28 days as a course of treatment, once a day;The 20ug nerve growth factor will be dissolved in 1 ml sterile water for injection and then injected intramuscularly at gluteal muscle, once a day for 4 weeks before the EA intervention. Dose modification is not allowed for mNGF.
Intervention Type
Drug
Intervention Name(s)
nerve growth factor
Intervention Description
The patient first received an intramuscular injection of NGF or saline into the gluteus maximus.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)
physiological saline
Other Intervention Name(s)
Sham EA intervention
Intervention Description
Other 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 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 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
the modified Rankin Score
Description
the modified Rankin Score is a common indicator to evaluate motor function in stroke patients.The modified Rankin Score ranges from 0 to 6, and the more severe the neurological deficit, the higher the score.
Time Frame
the end of treatment (week 4) in all four groups.
Secondary Outcome Measure Information:
Title
Fugl-Meyer Assessment of motor function score (FMA)
Description
Fugl-Meyer Assessment of motor function score (FMA) is a common indicator to evaluate motor function.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).
Time Frame
Fugl-Meyer Assessment of motor function score (FMA) is recorded at 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 (MBI) is a common indicator to evaluate motor function.The maximum total score of Modified Barthel Index is 100, with a higher score meaning less dependent to help.
Time Frame
Modified Barthel Index (MBI) is recorded at 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 (TUGT) is a common indicator to evaluate motor function.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
timed up and go test (TUGT) is recorded at 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
Tinetti Performance Oriented Mobility Assessment (POMA) is a common indicator to evaluate motor function.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
Tinetti Performance Oriented Mobility Assessment (POMA) is recorded at 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; 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
Yuan yuan WU, PHD
Phone
0571-88393504
Ext
+86
Email
zskjk08@163.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
Phone
13858028101
Ext
+86
Email
linxianming1966@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effect of EA Combined With NGF on Limb Function in Convalescent Patients With Ischemic Stroke

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