NCT06737549 Effect of Specific Mode Electroacupuncture Stimulation Combined with NGF on Dysphagia After Ischaemic Stroke: a Pilot Randomized Controlled Trial
| NCT ID | NCT06737549 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | The Third Affiliated hospital of Zhejiang Chinese Medical University |
| Condition | Ischemic Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 144 participants |
| Start Date | 2024-12 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 144 participants in total. It began in 2024-12 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06737549 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Ischemic Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06737549 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06737549 currently recruiting?
Yes, NCT06737549 is actively recruiting participants. Contact the research team at linxianming1966@163.com for enrollment information.
Where is the NCT06737549 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT06737549 clinical trial?
NCT06737549 is sponsored by The Third Affiliated hospital of Zhejiang Chinese Medical University. The trial plans to enroll 144 participants.
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