Effect of specific mode electroacupuncture stimulation combined with NGF on dysphagia after ischemic stroke: study protocol for a pilot randomized controlled trial.

Researchers are testing whether a combination of electroacupuncture and nerve growth factor (NGF) can help stroke survivors who have difficulty swallowing. Dysphagia, or swallowing difficulty, affects many people after an ischemic stroke and can lead to serious complications like choking or pneumonia. Currently, there are limited effective treatments available.

This study will enroll 144 stroke patients who will be randomly divided into four groups. One group will receive electroacupuncture with a specific electrical stimulation pattern plus NGF injections, while other groups will receive variations of this treatment or placebo versions. The special electroacupuncture technique is designed to temporarily open the blood-brain barrier, allowing the nerve growth factor to reach damaged brain areas more effectively. Patients will attend 18 treatment sessions over six weeks, followed by six weeks of monitoring.

Researchers will measure improvements using several swallowing assessment scales and check how well patients can eat different food textures. They'll also use brain imaging technology to see if the treatment changes brain function, and will track patients' overall independence and quality of life. Safety will be carefully monitored throughout the trial.

This is a pilot study, meaning it's designed to test whether this approach is feasible and shows promise before conducting larger trials. The results will help determine if combining electroacupuncture with nerve growth factor could become a new treatment option for stroke-related swallowing problems. If you're considering acupuncture for any condition, work with a licensed acupuncturist who has experience treating stroke patients.

This randomized controlled pilot trial investigates specific mode electroacupuncture stimulation (SMES) combined with nerve growth factor (NGF) for post-ischemic stroke dysphagia. The study randomizes 144 participants into four parallel groups (EA+NGF, EA+placebo, acupuncture+NGF, acupuncture+placebo) receiving 18 sessions over 6 weeks with 6-week follow-up. The SMES protocol leverages previous research demonstrating electroacupuncture's ability to modulate blood-brain barrier permeability, theoretically enhancing NGF delivery to ischemic neural tissue.

Primary outcome measures utilize the Functional Oral Intake Scale (FOIS), with secondary measures including DOSS, PAS, mRS, and MBI. Functional near-infrared spectroscopy (fNIRS) will assess neurological changes. The study employs intention-to-treat analysis with appropriate blinding and safety monitoring. This trial addresses the significant clinical gap in effective dysphagia interventions post-stroke and may establish preliminary evidence for SMES as a novel drug delivery enhancement mechanism. Results will inform larger efficacy trials and potential integration into multidisciplinary stroke rehabilitation protocols.