Effect of Specific Mode Electroacupuncture Stimulation Combined with NGF on Dysphagia After Ischaemic Stroke: a Pilot Randomized Controlled Trial

Effect of Specific Mode Electroacupuncture Stimulation Combined with NGF on Dysphagia After Ischaemic Stroke: a Pilot Randomized Controlled Trial (NCT06737549) is a Phase 4 interventional studying Ischemic Stroke and Dysphagia, sponsored by The Third Affiliated hospital of Zhejiang Chinese Medical University. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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.

What Stage of Research Is This?

Phase 4 studies happen after a treatment has been approved by the FDA. They monitor long-term safety, real-world effectiveness, and any rare side effects that only emerge in larger populations over longer periods. Phase 4 results sometimes lead to label changes, additional warnings, or — rarely — withdrawal of approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 144 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Ischemic Stroke subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 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; Who Should NOT Join This Trial: 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. Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

DRUG

Nerver growth factor (NGF) injection

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.

DRUG

Placebo injection

Patients will receive 2ml volume of physiological saline (PS) injected intramuscularly into the gluteal muscle, three times a week for 6 weeks.

DEVICE

EA 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.

DEVICE

Acupuncture 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.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

The Third Affiliated Hospital of Zhejiang Chinese Medical University

Hangzhou, Zhejiang, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06737549), the sponsor (The Third Affiliated hospital of Zhejiang Chinese Medical University), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06737549 clinical trial studying?

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 int… The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06737549?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06737549?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06737549. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06737549. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.