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

BACKGROUND

Dysphagia is a major complication following ischemic stroke, but lacks effective treatments. Our previous studies show specific mode electroacupuncture stimulation (SMES) is an alternative approach to open the blood-brain barrier (BBB). Delivery of NGF across the BBB by SMES may be effective for treating dysphagia after ischemic stroke. The aim of this study is to assess the efficacy and safety of SMES combined with NGF for dysphagia after ischemic stroke.

METHODS

A total of 144 participants will be randomly assigned to an electroacupuncture (EA) + NGF group, an EA + placebo group, an acupuncture + NGF group, or an acupuncture + placebo group in a ratio of 1:1:1:1. Patients will receive 18 sessions of treatment for 6 weeks and a follow up of 6 weeks. The primary outcome is the Functional Oral Intake Scale (FOIS), and the secondary outcomes are the Dysphagia Outcome and Severity Scale (DOSS), the Penetration Aspiration Scale (PAS), the modified Rankin Scale (mRS), and the Modified Barthel Index (MBI). The functional near-infrared spectroscopy (fNIRS) will be applied to detect the changes in neurological function. Additionally, blinding and safety will also be assessed. All analysis will be performed based on intention-to-treat.

DISCUSSION: This trial will explore the feasibility and provide potential evidence for the effectiveness and safety of SMES combined with NGF for dysphagia after ischemic stroke.

CLINICAL TRIAL REGISTRATION: https://www.clinicaltrials.gov/ct2/show/NCT06737549, identifier (NCT06737549).