Clinical trials

Stroke, as one of the most disabling neurological diseases worldwide, causes significant functional impairments in the lower limbs, severely affecting the quality of life of patients. Traditional neuroregulation techniques such as transcranial magnetic stimulation (TMS) and transcranial direct current/alternating current stimulation (tDCS/tACS) can only intervene in the cerebral cortex. Deep brain stimulation (DBS), which requires invasive craniotomy to implant electrodes and has certain risks, is difficult to fully meet the rehabilitation needs of patients. These treatment methods are insufficient. Transcranial Temporal Interference (TI) Stimulation, as a new non-invasive neuroregulation technology, generates low-frequency envelope signals through high-frequency electric fields to achieve precise stimulation of deep brain tissues, providing a new direction for the treatment of stroke. This study is a clinical research to explore the efficacy of TI technology in the treatment of lower limb dysfunction in stroke, aiming to expand the clinical practice of TI technology in the field of stroke rehabilitation and provide theoretical support and practical guidance for the transformation and application of TI technology.

Disorder of consciousness (DOC) is a common complication of severe central nervous system injury. It is defined as prolonged DOC when lasting more than 28 days. About 300,000-800,000 patients are affected worldwide, with an annual mortality rate of 29%-50%, causing a heavy social and family burden. Although progress has been made in pathophysiology, clinical outcomes remain unsatisfactory, and arousal treatment for DOC is still challenging. Internationally recommended therapies, such as neurotrophic drugs, hyperbaric oxygen and invasive neuromodulation, have side effects or uncertain efficacy. In traditional Chinese medicine, post-TBI DOC is classified as "shen hun" (mental clouding). Bloodletting at Jing-Well points promotes arousal by regulating qi and blood and unblocking collaterals. Preliminary studies showed it may improve consciousness in DOC patients, but with small samples and short observation periods. Acupuncture, such as the Xingnao Kaiqiao method, induces arousal by improving cerebral blood flow and activating neural networks. Our team proposed the "Jing-Well point-brain correlation" hypothesis and found that electrostimulation at Jing-Well points improves cognitive function, but lacks standardized assessment and large-sample evidence. Further research is needed to confirm its efficacy, mechanisms and suitable populations to provide high-quality evidence-based support.

Dysphagia is one of the most common and serious complications following stroke. It can easily lead to aspiration and aspiration pneumonia, reduce patients' quality of life, increase healthcare costs, and result in high mortality rates, making it a clinical issue that urgently needs to be addressed. Current mainstream therapies have limitations: neurostimulation targets a single pathway, while rehabilitation training offers only limited improvement in microcirculation and suffers from low patient compliance. Although acupuncture shows promise, it lacks high-quality randomized controlled evidence, and the specific acupuncture techniques lack standardized operational protocols, limiting their widespread adoption. In preliminary clinical practice, Chen Xiaokai, a renowned traditional Chinese medicine practitioner in Guangdong Province, developed the "Nine Pharyngeal Acupoints" (including Lianquan and Renying) based on the "resolving knots" theory. This approach can rapidly improve pharyngeal muscle tone and swallowing function. Basic research has confirmed that stimulation of these acupoints promotes pharyngeal circulation, activates the brainstem, and aids in the restoration of the swallowing reflex. This study aims to conduct a single-center, assessor-blinded, randomized, controlled, prospective superiority clinical trial. Using surface electromyography (EMG) as the core assessment tool, combined with swallowing videofluoroscopy and functional scales, the study will analyze the efficacy and neuro-muscular regulatory mechanisms of the "Nine Pharyngeal Acupoints" technique. The study is expected to clarify its therapeutic efficacy, establish standard operating procedures, and provide a basis for clinical implementation.