Perception gaps between patients and practitioners regarding safety, data security, and ethics of intracranial electrode implantation: a multi-center study

Deep brain stimulation (DBS), the most widely adopted form of chronic intracranial neuromodulation, has become a standard treatment for movement disorders, yet how patients and practitioners perceive associated safety risks, data security concerns, and ethical implications remains poorly understood. Misalignment between patient expectations and clinical reality can undermine informed consent, compromise treatment adherence, and erode public trust. We conducted a multi-center study combining (1) a cross-sectional survey of 327 DBS patients and 161 practitioners (123 Chinese, 38 international) across 30 Chinese provinces and 11 countries, including factual knowledge assessment and information source items, (2) semi-structured interviews with 18 patients and 12 practitioners, and (3) an informed consent process audit at 6 DBS centers. Ordinal logistic regression controlled for age, gender, and education. Qualitative data were analyzed using reflexive thematic analysis. After adjusting for demographic confounders, significant perception gaps persisted between patients and practitioners for surgical risk (adjusted OR 1.89, 95% CI 1.28–2.79), device risk (aOR 1.72, 1.18–2.52), and data security concerns (aOR 1.94, 1.32–2.85). Patients scored significantly lower on factual DBS knowledge (mean 2.67/8 vs. 6.84/8, p < 0.001), which partially mediated the perception gap (proportion mediated 47.0%, p < 0.01). Interviews with 30 stakeholders revealed four explanatory mechanisms: patients delegated risk assessment to surgeons, therapeutic urgency overrode deliberation, awareness of neural data risks was absent, and practitioners experienced tension between disclosure and patient wellbeing. A consent audit across 6 centers confirmed that conversations averaged 14 min, rarely addressed data security, and never assessed comprehension. Despite these divergences, both groups showed strong consensus on protecting vulnerable populations ( p = 0.254). DBS patients systematically underestimate risks compared to practitioners, driven partly by knowledge deficits that current informed consent processes do not address. These findings provide empirical evidence for redesigning consent practices and developing governance frameworks for DBS and the broader family of implantable neurotechnologies.