Ischemic StrokePhase 4NCT05231694
The Impact of Electroacupuncture Combined With NGF on Clinical Effect and Functional Changes on Ischemic Stroke
A Phase 4 study testing Nerver growth factor (NGF) injection and EA intervention in people with Ischemic Stroke, run by The Third Affiliated hospital of Zhejiang Chinese Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Nerver growth factor (NGF) injection and EA intervention
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 288 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2022to 31 Dec 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Third Affiliated Hospital of Zhejiang Chinese Medical University
Hangzhou, Zhejiang, 310000
Xianming Lin, PHD, linxianming1966@163.com
About this study
Official title: Specific Stimulation Mode Electroacupuncture Combined With NGF for Recovery Period of Ischemic Stroke：Protocol for a Randomized Controlled Clinical Trial
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.
- Conditions
- Ischemic Stroke
- Being tested
- Nerver growth factor (NGF) injection, Placebo injection, EA intervention, sham EA intervention
- Keywords
- ischemic stroke, Convalescence, Electroacupuncture, nerve growth factor
- Medical subject headings
- Ischemic Stroke, Convalescence, Hereditary Sensory and Autonomic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nerver growth factor (NGF) injectionDrug
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.
Placebo injectionDrug
The patients will receive 1ml volume of physiological saline (PS) injected into the gluteal muscle, once a day for 4 weeks.
EA interventionDevice
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.
sham EA interventionDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| sham EA + placebo group | Other | sham EA + placebo group contain sham EA intervention and placebo injection Receives: Drug: Placebo injection; Device: sham EA intervention |
| sham EA + NGF group | Other | sham EA + NGF group contain sham EA intervention and NGF injection Receives: Drug: Nerver growth factor (NGF) injection; Device: sham EA intervention |
| EA + placebo group | Other | EA + placebo group contain EA intervention and placebo injection Receives: Drug: Placebo injection; Device: EA intervention |
| EA + NGF group | Other | EA + NGF group contain EA intervention and NGF injection Receives: Drug: Nerver growth factor (NGF) injection; Device: EA intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: end of treatment (week 4)
Secondary outcomes (6)
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
Measured: baseline (week 0), Mid-term treatment (week 2) and end of treatment (week 4) in all four groups.
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.
Measured: baseline (week 0), Mid-term treatment (week 2) and end of treatment (week 4) in all four groups.
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
Measured: baseline (week 0), Mid-term treatment (week 2) and end of treatment (week 4) in all four groups.
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.
Measured: baseline (week 0), Mid-term treatment (week 2) and end of treatment (week 4) in all four groups.
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.
Measured: baseline (week 0), Mid-term treatment (week 2) and end of treatment (week 4) in all four groups.
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.
Measured: baseline (week 0), Mid-term treatment (week 2) and end of treatment (week 4) in all four groups.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2022
- Study start1 Apr 2022
- Primary completion30 Sep 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 288 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Third Affiliated hospital of Zhejiang Chinese Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Ningbo No.2 Hospital, second people hospital of lishui
- Responsible party
- Principal investigator, Xianming Lin, The Third Affiliated hospital of Zhejiang Chinese Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05231694
- Sponsor's protocol ID
- XLin
- Status last verified
- Jul 2022
- First submitted
- 30 Jan 2022
- Last updated
- 28 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data and results of this study need to be confirmed by Lin Xianming
Publications
Cao Y, Yu S, Zhang Q, Yu T, Liu Y, Sun Z, Zhao M, Wang W, Zhao JZ; Chinese Stroke Association Stroke Council Guideline. Chinese Stroke Association guidelines for clinical management of cerebrovascular disorders: executive summary and 2019 update of clinical management of intracerebral haemorrhage. Stroke Vasc Neurol. 2020 Dec;5(4):396-402. doi: 10.1136/svn-2020-000433. Epub 2020 Dec 1.
PubMed 33262243Zhao N, Zhang H, Liu T, Liu J, Xiang Y, Shu G, Li C, Xie J, Chen L. Neuromodulatory Effect of Sensorimotor Network Functional Connectivity of Temporal Three-Needle Therapy for Ischemic Stroke Patients with Motor Dysfunction: Study Protocol for a Randomized, Patient-Assessor Blind, Controlled, Neuroimaging Trial. Evid Based Complement Alternat Med. 2021 Jan 4;2021:8820324. doi: 10.1155/2021/8820324. eCollection 2021.
PubMed 33488759Byun K, Hyodo K, Suwabe K, Ochi G, Sakairi Y, Kato M, Dan I, Soya H. Positive effect of acute mild exercise on executive function via arousal-related prefrontal activations: an fNIRS study. Neuroimage. 2014 Sep;98:336-45. doi: 10.1016/j.neuroimage.2014.04.067. Epub 2014 May 2.
PubMed 24799137Cope M, Delpy DT. System for long-term measurement of cerebral blood and tissue oxygenation on newborn infants by near infra-red transillumination. Med Biol Eng Comput. 1988 May;26(3):289-94. doi: 10.1007/BF02447083. No abstract available.
PubMed 2855531Broderick JP, Adeoye O, Elm J. Evolution of the Modified Rankin Scale and Its Use in Future Stroke Trials. Stroke. 2017 Jul;48(7):2007-2012. doi: 10.1161/STROKEAHA.117.017866. Epub 2017 Jun 16. No abstract available.
PubMed 28626052Fugl-Meyer AR, Jaasko L, Leyman I, Olsson S, Steglind S. The post-stroke hemiplegic patient. 1. a method for evaluation of physical performance. Scand J Rehabil Med. 1975;7(1):13-31.
PubMed 1135616Son H, Park C. Effect of turning direction on Timed Up and Go test results in stroke patients. Eur J Phys Rehabil Med. 2019 Feb;55(1):35-39. doi: 10.23736/S1973-9087.18.05202-4. Epub 2018 Jul 6.
PubMed 29984566Chu JJ, Chen XJ, Shen SS, Zhang XF, Chen LY, Zhang JM, He J, Zhao JF. A poor performance in comprehensive geriatric assessment is associated with increased fall risk in elders with hypertension: a cross-sectional study. J Geriatr Cardiol. 2015 Mar;12(2):113-8. doi: 10.11909/j.issn.1671-5411.2015.02.006.
PubMed 25870613Zhao W, You H, Jiang S, Zhang H, Yang Y, Zhang M. Effect of Pro-kin visual feedback balance training system on gait stability in patients with cerebral small vessel disease. Medicine (Baltimore). 2019 Feb;98(7):e14503. doi: 10.1097/MD.0000000000014503.
PubMed 30762779Huang J, Lin Z, Wang Q, Liu F, Liu J, Fang Y, Chen S, Zhou X, Hong W, Wu J, Madrigal-Mora N, Zheng G, Yang S, Tao J, Chen L. The effect of a therapeutic regimen of Traditional Chinese Medicine rehabilitation for post-stroke cognitive impairment: study protocol for a randomized controlled trial. Trials. 2015 Jun 16;16:272. doi: 10.1186/s13063-015-0795-x.
PubMed 26077459Larsson AC, Palstam A, Persson HC. Physical Function, Cognitive Function, and Daily Activities in Patients Hospitalized Due to COVID-19: A Descriptive Cross-Sectional Study in Sweden. Int J Environ Res Public Health. 2021 Nov 4;18(21):11600. doi: 10.3390/ijerph182111600.
PubMed 34770113Lu H, Zhang T, Wen M, Sun L. Impact of repetitive transcranial magnetic stimulation on post-stroke dysmnesia and the role of BDNF Val66Met SNP. Med Sci Monit. 2015 Mar 14;21:761-8. doi: 10.12659/MSM.892337.
PubMed 25770310Cai Y, Zhang CS, Ouyang W, Li J, Nong W, Zhang AL, Xue CC, Wen Z. Electroacupuncture for poststroke spasticity (EAPSS): protocol for a randomised controlled trial. BMJ Open. 2018 Feb 27;8(2):e017912. doi: 10.1136/bmjopen-2017-017912.
PubMed 29487073Yu KW, Lin CL, Hung CC, Chou EC, Hsieh YL, Li TM, Chou LW. Effects of electroacupuncture on recent stroke inpatients with incomplete bladder emptying: a preliminary study. Clin Interv Aging. 2012;7:469-74. doi: 10.2147/CIA.S37531. Epub 2012 Nov 8.
PubMed 23152677Baber N. International conference on harmonisation of technical requirements for registration of pharmaceuticals for human use (ICH). Br J Clin Pharmacol. 1994 May;37(5):401-4. doi: 10.1111/j.1365-2125.1994.tb05705.x. No abstract available.
PubMed 8054244
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Specific Stimulation Mode Electroacupuncture Combined With NGF for Recovery Period of Ischemic Stroke：Protocol for a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05231694
- Acronym / sponsor ID
- XLin
- Conditions
- Ischemic Stroke
- Keywords
- ischemic stroke, Convalescence, Electroacupuncture, nerve growth factor
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 288 participants (estimated)
- Lead sponsor
- The Third Affiliated hospital of Zhejiang Chinese Medical UniversityUniversity, hospital or other
- Collaborators
- Ningbo No.2 Hospital, second people hospital of lishui
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 9 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| sham EA + placebo group | Other | Drug: Placebo injection, Device: sham EA interventionsham EA + placebo group contain sham EA intervention and placebo injection |
| sham EA + NGF group | Other | Drug: Nerver growth factor (NGF) injection, Device: sham EA interventionsham EA + NGF group contain sham EA intervention and NGF injection |
| EA + placebo group | Other | Drug: Placebo injection, Device: EA interventionEA + placebo group contain EA intervention and placebo injection |
| EA + NGF group | Other | Drug: Nerver growth factor (NGF) injection, Device: EA interventionEA + NGF group contain EA intervention and NGF injection |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nerver growth factor (NGF) injectionThe 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. | Drug | EA + NGF group, sham EA + NGF group |
| Placebo injectionThe patients will receive 1ml volume of physiological saline (PS) injected into the gluteal muscle, once a day for 4 weeks. | Drug | EA + placebo group, sham EA + placebo group |
| EA interventionPatients 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. | Device | EA + NGF group, EA + placebo group |
| sham EA interventionThe 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. | Device | sham EA + NGF group, sham EA + placebo group |
Primary outcome
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.
6 secondary outcomes
simplified Fugl-Meyer Assessment of motor function score (FMA)
Time frame: baseline (week 0), Mid-term treatment (week 2) and end of treatment (week 4) in all four groups.
Modified Barthel Index (MBI)
Time frame: baseline (week 0), Mid-term treatment (week 2) and end of treatment (week 4) in all four groups.
timed up and go test (TUGT)
Time frame: baseline (week 0), Mid-term treatment (week 2) and end of treatment (week 4) in all four groups.
Tinetti Performance Oriented Mobility Assessment (POMA)
Time frame: baseline (week 0), Mid-term treatment (week 2) and end of treatment (week 4) in all four groups.
Montreal Cognitive Assessment (MoCA)
Time frame: baseline (week 0), Mid-term treatment (week 2) and end of treatment (week 4) in all four groups.
Loewenstein Occupational Therapy Cognitive Assessment (LOTCA)
Time frame: baseline (week 0), Mid-term treatment (week 2) and end of treatment (week 4) in all four groups.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2022.
- Results publication: PubMed 33262243Cao Y, Yu S, Zhang Q, Yu T, Liu Y, Sun Z, Zhao M, Wang W, Zhao JZ; Chinese Stroke Association Stroke Council Guideline. Chinese Stroke Association guidelines for clinical management of cerebrovascular disorders: executive summary and 2019 update of clinical management of intracerebral haemorrhage. Stroke Vasc Neurol. 2020 Dec;5(4):396-402. doi: 10.1136/svn-2020-000433. Epub 2020 Dec 1.
- Results publication: PubMed 33488759Zhao N, Zhang H, Liu T, Liu J, Xiang Y, Shu G, Li C, Xie J, Chen L. Neuromodulatory Effect of Sensorimotor Network Functional Connectivity of Temporal Three-Needle Therapy for Ischemic Stroke Patients with Motor Dysfunction: Study Protocol for a Randomized, Patient-Assessor Blind, Controlled, Neuroimaging Trial. Evid Based Complement Alternat Med. 2021 Jan 4;2021:8820324. doi: 10.1155/2021/8820324. eCollection 2021.
- Results publication: PubMed 24799137Byun K, Hyodo K, Suwabe K, Ochi G, Sakairi Y, Kato M, Dan I, Soya H. Positive effect of acute mild exercise on executive function via arousal-related prefrontal activations: an fNIRS study. Neuroimage. 2014 Sep;98:336-45. doi: 10.1016/j.neuroimage.2014.04.067. Epub 2014 May 2.
- Results publication: PubMed 2855531Cope M, Delpy DT. System for long-term measurement of cerebral blood and tissue oxygenation on newborn infants by near infra-red transillumination. Med Biol Eng Comput. 1988 May;26(3):289-94. doi: 10.1007/BF02447083. No abstract available.
- Results publication: PubMed 28626052Broderick JP, Adeoye O, Elm J. Evolution of the Modified Rankin Scale and Its Use in Future Stroke Trials. Stroke. 2017 Jul;48(7):2007-2012. doi: 10.1161/STROKEAHA.117.017866. Epub 2017 Jun 16. No abstract available.
- Results publication: PubMed 1135616Fugl-Meyer AR, Jaasko L, Leyman I, Olsson S, Steglind S. The post-stroke hemiplegic patient. 1. a method for evaluation of physical performance. Scand J Rehabil Med. 1975;7(1):13-31.
- Results publication: PubMed 29984566Son H, Park C. Effect of turning direction on Timed Up and Go test results in stroke patients. Eur J Phys Rehabil Med. 2019 Feb;55(1):35-39. doi: 10.23736/S1973-9087.18.05202-4. Epub 2018 Jul 6.
- Results publication: PubMed 25870613Chu JJ, Chen XJ, Shen SS, Zhang XF, Chen LY, Zhang JM, He J, Zhao JF. A poor performance in comprehensive geriatric assessment is associated with increased fall risk in elders with hypertension: a cross-sectional study. J Geriatr Cardiol. 2015 Mar;12(2):113-8. doi: 10.11909/j.issn.1671-5411.2015.02.006.
- Results publication: PubMed 30762779Zhao W, You H, Jiang S, Zhang H, Yang Y, Zhang M. Effect of Pro-kin visual feedback balance training system on gait stability in patients with cerebral small vessel disease. Medicine (Baltimore). 2019 Feb;98(7):e14503. doi: 10.1097/MD.0000000000014503.
- Results publication: PubMed 26077459Huang J, Lin Z, Wang Q, Liu F, Liu J, Fang Y, Chen S, Zhou X, Hong W, Wu J, Madrigal-Mora N, Zheng G, Yang S, Tao J, Chen L. The effect of a therapeutic regimen of Traditional Chinese Medicine rehabilitation for post-stroke cognitive impairment: study protocol for a randomized controlled trial. Trials. 2015 Jun 16;16:272. doi: 10.1186/s13063-015-0795-x.
- Results publication: PubMed 34770113Larsson AC, Palstam A, Persson HC. Physical Function, Cognitive Function, and Daily Activities in Patients Hospitalized Due to COVID-19: A Descriptive Cross-Sectional Study in Sweden. Int J Environ Res Public Health. 2021 Nov 4;18(21):11600. doi: 10.3390/ijerph182111600.
- Results publication: PubMed 25770310Lu H, Zhang T, Wen M, Sun L. Impact of repetitive transcranial magnetic stimulation on post-stroke dysmnesia and the role of BDNF Val66Met SNP. Med Sci Monit. 2015 Mar 14;21:761-8. doi: 10.12659/MSM.892337.
- Individual participant dataSharing planned: No. The data and results of this study need to be confirmed by Lin Xianming
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nerver growth factor (NGF) injection and EA intervention in people with Ischemic Stroke, run by The Third Affiliated hospital of Zhejiang Chinese Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact xianming Lin, PHD (+86-13858028101, linxianming1966@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
basic cure rate (time frame: end of treatment (week 4)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05231694, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2022.