A Prospective, Randomized, Controlled Superiority Trial of Connectome-Guided Navigation-Assisted Microsurgical Resection for Functional Preservation in Eloquent-Area Brain Tumors

This is a prospective, randomized, controlled superiority trial designed to evaluate whether connectome-guided navigation-assisted microsurgical resection improves postoperative functional preservation in patients with tumors located in eloquent brain regions when compared with conventional tractography-guided surgery.

Brain tumors involving language areas, motor areas, or key large-scale functional networks present a major surgical challenge because maximal resection must be balanced against preservation of neurological function. Conventional neuronavigation based mainly on structural landmarks or tractography may be insufficient to fully characterize the topological relationship between the tumor and critical functional networks. This study therefore applies a connectome-informed surgical strategy that integrates preoperative structural and functional imaging with intraoperative guidance to support individualized surgical planning and functional protection.

Eligible patients are those with brain tumors involving language, motor, or major functional network regions, including the default mode network, central executive network, dorsal attention network, and ventral attention network, with Karnofsky Performance Status of at least 70 and preoperative MRI evidence of a spatial relationship between the tumor and major white matter tracts. Patients with non-neoplastic lesions, multifocal tumors, incomplete evaluation data, pregnancy-related conditions, or extensive adhesion to multiple key network nodes are excluded.

Participants are randomized in a 1:1 ratio to the experimental group or the control group. The experimental intervention includes preoperative DTI and resting-state functional MRI-based brain network reconstruction, intraoperative real-time navigation, electrophysiological monitoring, and resection planning based on network-informed boundaries. The control intervention consists of conventional DTI tractography-guided tumor resection.

The primary endpoint is postoperative functional preservation. Secondary endpoints include extent of resection, postoperative complication rate, time to neurological recovery, overall survival, progression-related outcomes, and quality of life. Exploratory analyses will assess postoperative dynamic changes in brain networks and functional compensation mechanisms using multimodal MRI data, including resting-state functional MRI and diffusion imaging.