A novel self-controlled electroacupuncture helmet for chemotherapy-induced cognitive impairment: Results from a prospective randomized trial.

Abstract

337 Background: Chemotherapy-induced cognitive impairment (CICI) affects 30% of cancer patients, with limited treatment options. Traditional acupuncture suffers from efficacy variability (±40%), while transcranial magnetic stimulation (TMS) devices are costly ($75,000/unit) and confined to hospitals. We developed a self-controlled electroacupuncture helmet (SCEH) with multi-point stimulation and neural adaptive technology to address these limitations. Methods: In this single-blind, randomized trial (NCT05876988), 83 CICI patients (MoCA≤26) were allocated to SCEH (6-channel NAU stimulation) vs. sham device (1-channel). Treatment consisted of 45-minute sessions twice weekly for 8 weeks. Primary endpoint was MoCA score change at week 4. Secondary endpoints included digit span test, EORTC QLQ-C30, and safety. Results: The SCEH group showed significantly greater MoCA improvement at week 4 (Δ4.2±0.8 vs. 1.3±0.6, p<0.001) and week 8 (Δ6.5±1.2 vs. 2.1±0.7, p<0.001). 85% of SCEH patients achieved clinically significant improvement (≥3-point MoCA increase) versus 35% in controls (p<0.01). Digit span test showed working memory enhancement (p<0.05), and QLQ-C30 revealed improved quality of life (p<0.01). No serious adverse events occurred, with only 1.9% experiencing transient scalp erythema. Conclusion: The SCEH demonstrates rapid efficacy (2-week onset), high safety profile, and home-use capability. Its standardized stimulation parameters overcome traditional acupuncture's variability, while costing one-third of imported TMS devices. This non-invasive neuromodulation approach offers a promising solution for CICI management. Clinical trial information: NCT05876988 .