Individualised stimulation parameters in deep brain stimulation for Parkinson’s disease based on disease phenotype and brain connectivity: protocol for a randomised feasibility study in a tertiary care centre (iDBS trial)

BACKGROUND: Bilateral deep brain stimulation (DBS) of the subthalamic nucleus (STN) is a well-accepted treatment for advanced Parkinson's disease (PD). Currently, programming of the DBS is done in a trial-and-error manner and it can take up to 12 months to reach optimal stimulation parameters. Technological advances in electrode design and implantable pulse generator capabilities lead to an almost infinite number of stimulation options. To explore the potential benefit of all these technological advances, a conventional trial-and-error approach is no longer sufficient. Consequently, there is a clear need for a more computational approach to programming DBS systems. This pilot study is a prospective trial to prove the feasibility of programming bilateral STN-DBS for PD in a computational fashion based on patient anatomy, electrode position and brain connectivity. In this study, we aim to assess the safety, practical feasibility and technical feasibility of a computational approach for programming newly implanted STN-DBS patients with PD. This computational approach will be based on a patient-specific DBS setting regarding sweet spots and structural connectivity of the STN. The results of this pilot study will be used to develop a computational approach for DBS programming to use in a future randomised clinical trial. METHODS AND ANALYSIS: The iDBS trial will be a prospective randomised feasibility study carried out at the Radboud university medical center. A total of 24 patients with PD eligible for bilateral STN-DBS surgery implanted with Boston Scientific Cartesia leads will be included. Patients will be randomised to receive either (1) computational DBS programming (n=12) or (2) conventional DBS programming based on monopolar review (n=12). The primary endpoints are safety (occurrence of stimulation-induced side effects, duration of induced side effects (temporary or permanent), severity of the stimulation-induced side effects) and technical feasibility (time from surgery to DBS initiation, time from surgery to reaching optimal DBS stimulation settings) of the computational workflow. ETHICS AND DISSEMINATION: Ethical approval for this study has been granted by the Medical Ethical Committee region Arnhem-Nijmegen, the Netherlands (2024-17453). This study will be conducted in accordance with the Declaration of Helsinki and all applicable European and Dutch law. All participants will have to provide written informed consent. Results of the study will be submitted for publication in peer-reviewed journals and conferences. TRIAL REGISTRATION NUMBER: The study is registered in the OMON-registry (NL87334.091.24, NL-OMON57446).