Clinical trials

Post-stroke dysphagia is a common complication of stroke and may lead to impaired oral intake, malnutrition, aspiration, and pneumonia. Reduced tongue strength and tongue pressure are important contributors to impaired swallowing after stroke. Conventional tongue-pressure resistance training may improve tongue strength, but traditional training provides limited real-time feedback and may be difficult to individualize.This prospective, multicenter, randomized, open-label, parallel-controlled trial will evaluate the effectiveness of digital intelligent tongue-pressure biofeedback resistance training in patients with post-stroke dysphagia. A total of 80 participants will be randomly assigned in a 1:1 ratio to an intervention group or a control group. Participants in the intervention group will receive digital intelligent tongue-pressure biofeedback resistance training in addition to conventional swallowing rehabilitation, while participants in the control group will receive conventional rehabilitation without the digital biofeedback intervention. The intervention period will last 2 weeks.Swallowing function will be assessed at baseline and after completion of the intervention. The primary outcome is the change in Functional Oral Intake Scale (FOIS) score. Secondary assessments include maximum tongue pressure and quantitative videofluoroscopic swallowing study (VFSS) measures, including oral transit time, Penetration-Aspiration Scale score, and pharyngeal residue. The study aims to determine whether digital intelligent tongue-pressure biofeedback resistance training provides additional benefits for swallowing function, tongue strength, and swallowing safety in patients with post-stroke dysphagia.

This randomized, double-blind, sham-controlled clinical trial will investigate the effects and potential neural mechanisms of pharyngeal air-pulse sensory stimulation in patients with post-stroke dysphagia. A total of 80 participants with swallowing impairment after stroke will be randomly assigned in a 1:1 ratio to either an active stimulation group or a sham stimulation group. Both groups will receive conventional swallowing rehabilitation, while the active group will additionally receive pharyngeal air-pulse sensory stimulation and the control group will receive sham stimulation for 2 weeks. Swallowing function and neurophysiological changes will be assessed before and after the intervention. Assessments will include clinical swallowing evaluations, videofluoroscopic swallowing study, surface electromyography, resting-state and task-based functional magnetic resonance imaging, and diffusion kurtosis imaging. The study aims to determine whether pharyngeal air-pulse sensory stimulation can improve swallowing function and to explore associated changes in swallowing-related sensory-motor brain networks after stroke.

Irritable bowel syndrome (IBS) is a functional gastrointestinal disorder characterized by recurrent abdominal pain and altered bowel habits. Under the Rome IV criteria, IBS can be classified into constipation-predominant (IBS-C), diarrhea-predominant (IBS-D), mixed (IBS-M), and unclassified (IBS-U) subtypes. IBS-D represents one of the most clinically disruptive phenotypes due to the combined burden of abdominal pain and frequent loose stools1. These symptoms are the major drivers of impaired quality of life and healthcare utilization. Despite available pharmacologic treatments, recurrence rates remain high and adverse effects often limit patient satisfaction, creating an unmet need for safe and effective alternative therapies. Transcutaneous Electrical Acustimulation (TEA) is an emerging therapy which delivers appropriate electrical stimulation to acupoints that are in the vicinity of peripheral nerves through surface electrodes, has been demonstrated to improve bowel symptoms and visceral hypersensitivity by modulating autonomic function and brain-gut interaction2. Previous trials of TEA in IBS have shown improvement in bowel symptoms, pain, and quality of life, with good safety and tolerability2,3. However, multicenter evidence for IBS-D is lacking. This trial aims to evaluate whether TEA can improve overall symptoms in patients with IBS-D. Specifically, the primary objective is to assess the effect of TEA on the composite responder rate, defined by concurrent improvement in both abdominal pain and loose stool days. Secondary objectives include evaluating broader symptom severity, stool characteristics, as well as on quality of life, psychological symptoms, and the durability of clinical benefits during follow-up.