Electroacupuncture and NGF treatment for swallowing difficulties after stroke

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

This study is testing if a combination of electroacupuncture and nerve growth factor injections can help stroke survivors with swallowing difficulties improve their swallowing and brain recovery.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 144 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: The Third Affiliated hospital of Zhejiang Chinese Medical University (Academic / other)
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT06737549 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the combined effect of specific mode electroacupuncture stimulation and nerve growth factor (NGF) injections on patients experiencing dysphagia following an ischemic stroke. The study aims to determine if this combination can enhance the delivery of NGF across the blood-brain barrier, thereby improving swallowing function and overall brain recovery. Participants will receive either the active treatment or a placebo, and their progress will be monitored to assess the efficacy of the intervention. The trial is designed to provide insights into a novel approach for neurorehabilitation in stroke patients.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 who have experienced their first ischemic stroke and have confirmed dysphagia.

Not a fit: Patients with dysphagia not caused by ischemic stroke or those with severe cognitive impairment may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve swallowing function in patients recovering from ischemic stroke.

How similar studies have performed: Previous studies have shown promise in using electroacupuncture for neurological rehabilitation, but this specific combination with NGF is novel.

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.

Where this trial is running

Hangzhou, Zhejiang

• The Third Affiliated Hospital of Zhejiang Chinese Medical University — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Study coordinator: Xianming Lin, PHD

Conditions Ischemic Stroke; Dysphagia