Clinical study endpoints serve to evaluate the effectiveness and safety of medical interventions of iBCIs, thus facilitating the path to regulatory approval and clinical adoption. Since iBCIs are in many ways novel from the standpoint of regulatory approval and reimbursement, the field is presented with the unique challenge of identifying or developing specific endpoints that accurately reflect the technology’s impact on people’s lives. Endpoints may be different for different use cases and may evolve as the devices evolve.

This Workgroup is driven by the need to clearly define endpoints, including considering previously validated endpoints, that can be adopted into a regulatory approval pathway for iBCIs and then utilized for clinical adoption. This Workgroup is particularly focused on establishing or identifying efficacy endpoints, while leveraging the existing precedents set by other implantable devices to address safety concerns.