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Taking people in ChinaPhase 4

Tests acupuncture with nerve growth factor for swallowing trouble after stroke

Tests electroacupuncture with a nerve growth factor injection in adults with swallowing difficulty after stroke.

Key facts

Who runs it
The Third Affiliated hospital of Zhejiang Chinese Medical University
Where
Hangzhou, ChinaSee the site
Trial code
Registry title
Effect of Specific Mode Electroacupuncture Stimulation Combined with NGF on Dysphagia After Ischaemic Stroke: a Pilot Randomized Controlled Trial
Status
Recruiting
Phase
Phase 4
People taking part
144 people, planned
Started
Dec 2024
Expected to end
Dec 2027
Type of study
Interventional, 4 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • Nerver growth factor (NGF) injection
  • Placebo injection
  • EA intervention
  • Acupuncture intervention
Record updated
17 December 2024

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults who have swallowing trouble after their first ischemic stroke. It tests electroacupuncture combined with nerve growth factor (NGF) injections.

Age
18 to 80 years old
Sex
Men and women can join
Disease stage
First-ever ischemic stroke confirmed by CT and/or MRI, 15 to 180 days since onset, with swallowing trouble (dysphagia) confirmed by a videofluoroscopic swallowing study (VFSS)
Earlier treatment
No medication that may change cortical excitability in the past 2 months

Main reasons for not taking part

  • Swallowing trouble before the stroke or not caused by the stroke
  • Repeated strokes, past brain surgery, or brain infarction caused by injury or tumor
  • Severe heart, liver or kidney problems, or severe blood clotting problems
  • Cardiac pacemaker, allergy to NGF, or inability to undergo VFSS
  • Taking part in another clinical trial now or one that ended within the last 3 months

The registry criteria, word for word

Show all 20 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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
  • 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
  • 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

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 80 years old?

Where in China

  • the Third Affiliated Hospital of Zhejiang Chinese Medical UniversityHangzhou, ChinaContact: Xianming Lin, PHDTaking people

About the trial

What the trial wants to find out

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.

The 4 groups in the trial

  • EA + NGF groupTreatment being tested

    Treatment: Nerver growth factor (NGF) injection and EA intervention

  • EA + placebo groupPlacebo, for comparison

    Treatment: Placebo injection and EA intervention

  • Acupuncture + NGF groupSham treatment, for comparison

    Treatment: Nerver growth factor (NGF) injection and Acupuncture intervention

  • Acupuncture + placebo groupSham treatment, for comparison

    Treatment: Placebo injection and Acupuncture intervention

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Effect of Specific Mode Electroacupuncture Stimulation Combined with NGF on Dysphagia After Ischaemic Stroke: a Pilot Randomized Controlled Trial
Plain-language title
Tests acupuncture with nerve growth factor for swallowing trouble after strokeGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT06737549, who can take part
Publications
Record updated
17 December 2024