A Non-Invasive Bioceramic Head-Worn Device for Meridian-Linked Trigger Point Relief: Safety,Workflow,and AI Decision Support

This exploratory feasibility study evaluated a noninvasive bioceramic frontal head-worn device for meridian-linked trigger point relief in adults with musculoskeletal or stress-related discomfort. Fifty participants completed one 20 min device session. Symptom-relevant meridian-linked trigger points were assessed using a 0–10 visual analog scale (VAS) immediately before and after stimulation. The primary aims were to evaluate operational feasibility, safety/tolerability, device usability, and outcome capture. Optional artificial intelligence (AI) decision-support modules provided symptom-to-meridian suggestions, camera-based positioning cues, and parameter presets; these modules supported practitioner workflow only and were not evaluated as independent diagnostic or therapeutic systems. Forty-six participants contributed at least one complete pre–post VAS pair. Because endpoint selection was symptom-guided rather than universally applied to all bilateral meridian points, endpoint-level n varied across channels and sides. Within-session VAS reductions were observed at several endpoints; however, given the uncontrolled design and subjective outcome, these findings should be interpreted as preliminary feasibility signals rather than definitive therapeutic efficacy. No serious adverse events occurred, and prespecified safety limits were met. Five organ meridians (liver, spleen, lung, heart, kidney) were prespecified as primary for interpretation; all others were exploratory. These findings support progression to randomized, sham-controlled studies incorporating objective physiological biomarkers such as HRV, EEG, and microcirculatory perfusion, together with prospective evaluation of the AI-assisted targeting workflow.