Dysphagia, Ischemic Stroke
Conditions
Brief summary
Ischemic stroke is a common clinical disease, often accompanied by dysphagia. At present, clinical treatment for patients with dysphagia after ischemic stroke is limited. 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 mode electroacupuncture stimulation combined with NGF treatment on patients with dysphagia after ischemic stroke 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.
Interventions
The 20ug mouse nerve growth factor (NO. S20060051, Jinlujie) will be obtained from Hiteck Biopharmaceutical Co., Ltd., Wuhan, China. mNGF will be dissolved in 2 ml of sterile water for injection and then injected intramuscularly into the gluteal muscle, three times a week for 6 weeks.
DRUGPlacebo injection
Patients will receive 2ml volume of physiological saline (PS) injected intramuscularly into the gluteal muscle, three times a week for 6 weeks.
DEVICEEA intervention
Patients take supine position. After skin disinfection with 75% ethanol routine disinfection, the stainless needle (size 0.25mm×40mm, Hwato 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 Jisheng, Ltd., China) with a frequency of 2/100 Hz and an intensity of patient can tolerate, targeting a current strength of 3.0mA, for 40 min (a homemade relay cycled power to the electrode for 6 sec on and 6 sec off), three times a week for 6 weeks.
DEVICEAcupuncture intervention
Patients take supine position. After skin disinfection with 75% ethanol routine disinfection, the stainless needle (size 0.25mm×40mm, Hwato 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 connected to an acupuncture point nerve stimulator (HANS-200, Nanjing Jisheng, Ltd., China) without closed circuit, 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), three times a week for 6 weeks.
Sponsors
The Third Affiliated hospital of Zhejiang Chinese Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Patients with first-ever ischemic stroke confirmed by Computed Tomography (CT) and/or Magnetic Resonance Imaging (MRI); 2. Onset time ranged from 15 days to 180 days; 3. Aged 18 to 80 years old, male or female; 4. Dysphagia confirmed by a videofluoroscopic swallowing study (VFSS); 5. Patients who are able to accept and comply with acupuncture, electroacupuncture treatment, gluteal intramuscular injection, and have good compliance; 6. Have provided signed consent and exhibit willingness to participate in the trial. 7. Women who are lactating, pregnant or intending to get pregnant;
Exclusion criteria
1. Patients with dysphagia before ischemic stroke onset or dysphagia not caused by ischemic stroke; 2. Patients with severe cognitive impairment; 3. Patients with severe cardiac, hepatic, and renal dysfunction, as well as severe coagulation abnormalities; 4. Patients with other abnormal test results who are deemed unsuitable to participate in this study by the investigator. 5. Multiple occurrences of stroke, or a history of craniocerebral surgery, or cerebral infarction caused by trauma or brain tumors. 6. Patients with severe neurological deficits prior to ischemic stroke, such as visual and auditory impairments, aphasia, agnosia, severe hemiplegia, and other conditions. 7. Women who are lactating, pregnant or intending to get pregnant; 8. Patients with a history of needle fainting or with skin infections at the acupuncture site. 9. Cardiac pacemaker carrier; 10. Patients allergic to NGF; 11. The inability to undergo VFSS; 12. Patients with a medication history that may alter cortical excitability within the past 2 months. 13. Patients who are currently participating in other clinical trials or have participated in clinical trials that ended within the last 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Functional Oral Intake Scale (FOIS) | week 0, week 2, week 4, week 6, week 12 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dysphagia Outcome and Severity Scale (DOSS) | week 0, week 6 | — |
| Penetration Aspiration Scale (PAS) | week 0, week 6 | — |
| modified Rankin Scale (mRS) | week 0, week 2, week 4, week 6 | — |
| Modified Barthel Index (MBI) | week 0, week 2, week 4, week 6 | — |
| Oxygenated hemoglobin and deoxygenated hemoglobin in cerebral cortex | week 0, week 6 | Measure method: fNIRS |
Countries
China
Contacts
Primary ContactXianming Lin, PHD
Backup ContactXiaoyang Yu
Outcome results
None listed