NCT06737549RecruitingPhase 4
Effect of Specific Mode Electroacupuncture Stimulation Combined with NGF on Dysphagia After Ischaemic Stroke: a Pilot Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 17 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 144 (estimated)
- First submitted
- 12 Dec 2024
- Start date
- Dec 2024
- Primary completion date
- Dec 2027
- Lead sponsor
- The Third Affiliated hospital of Zhejiang Chinese Medical University
- Diseases
- Stroke
- NCT number
- NCT06737549
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 144
- From Dec 2024 to the primary completion date, Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with severe neurological deficits prior to ischemic stroke, such as visual and auditory impairments, aphasia, agnosia, severe hemiplegia, and other conditions.
- Patients with a medication history that may alter cortical excitability within the past 2 months.
Other illness
- Patients with dysphagia before ischemic stroke onset or dysphagia not caused by ischemic stroke;
- Patients with severe cognitive impairment;
- Patients with severe cardiac, hepatic, and renal dysfunction, as well as severe coagulation abnormalities;
- Multiple occurrences of stroke, or a history of craniocerebral surgery, or cerebral infarction caused by trauma or brain tumors.
- Patients with a history of needle fainting or with skin infections at the acupuncture site.
- Cardiac pacemaker carrier;
- Patients allergic to NGF;
Other
- Patients with other abnormal test results who are deemed unsuitable to participate in this study by the investigator.
- Women who are lactating, pregnant or intending to get pregnant;
- The inability to undergo VFSS;
- Patients who are currently participating in other clinical trials or have participated in clinical trials that ended within the last 3 months.
Who the study is looking for
- Patients with first-ever ischemic stroke confirmed by Computed Tomography (CT) and/or Magnetic Resonance Imaging (MRI);
- Onset time ranged from 15 days to 180 days;
- Aged 18 to 80 years old, male or female;
- Dysphagia confirmed by a videofluoroscopic swallowing study (VFSS);
- Patients who are able to accept and comply with acupuncture, electroacupuncture treatment, gluteal intramuscular injection, and have good compliance;
- Have provided signed consent and exhibit willingness to participate in the trial.
- Women who are lactating, pregnant or intending to get pregnant;
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| the Third Affiliated Hospital of Zhejiang Chinese Medical University Coordinator of this site? Confirm its status | Hangzhou | China | Recruiting |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.