FDA approves BrainGate2 Investigational Device Exemption; multi-site clinical trial begins

BrainGate consortium

The FDA granted an Investigational Device Exemption (IDE) for the BrainGate2 neural interface system, enabling a second-generation multi-site clinical trial. The trial was initiated by Massachusetts General Hospital, Brown University, and Providence VA, and later expanded to include Stanford (2011), and subsequently Case Western, Emory, UC Davis, Rice, and Baylor. Unlike the original BrainGate trial limited to tetraplegia, BrainGate2 enrolled participants across multiple diagnoses including ALS, spinal cord injury, and brainstem stroke.

• FDA IDE approval enabled transition from single-site to multi-site research network.
• Broadened inclusion criteria to multiple diagnoses beyond tetraplegia.
• Consortium model allows knowledge-sharing and trial coordination across academic institutions.
• Funding from NIH, VA, DoD, and philanthropic sources.