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We’re thrilled to be teaming up with our partners at iBCI‑CC to bring another special pre‑conference workshop to ASNR2026: Los Angeles!
"Defining Success and Eligibility for Implantable Brain-Computer Interfaces"
As implantable brain-computer interfaces (iBCIs) enter pivotal clinical trials, decisions made now will shape regulatory approval, reimbursement, and ultimately who will have access to these potentially life-changing technologies. This workshop brings together clinicians to provide input on two foundational questions: (1) what outcomes matter to patients and clinicians and (2) whether iBCI trial populations should be defined by disease/injury or by function/impairment. Through guided discussion, this session aims to build consensus on frameworks that support effective trial design and equitable access to iBCIs.
Tuesday, March 24, 2026
6:00pm - 8:00pm
Doors open at 5:30pm
Hyatt Regency Long Beach, Shoreline Room
Dinner Included
Registration: $40
The registration form for this event is included in the registration form for ASNR2026, but can be selected as a standalone option as well.
Note: If you have already registered for the ASNR 2026 Annual Meeting and want to attend this workshop, please do not click on the Register Now button. Instead, visit www.asnr.com/asnr2026/add-workshop for step-by-step instructions on how to add the workshop to your existing registration.
Featured Speakers:
Vivek Pinto,
PhD, MBA
Devjani Saha,
PhD
Mijail Serruya,
MD, PhD
Jessica Kelemen,
MBA
1. What outcomes matter to patients and clinicians?
Clinical trials must be designed to demonstrate benefit in terms that matter to patients. This requires understanding the aspects of health that are most meaningful to patients (i.e., “Meaningful Aspects of Health”) and identifying concepts related to those aspects that are both measurable and reflective of iBCI benefit (i.e., “Concepts of Interest”). Establishing a consensus-driven framework for this process will guide endpoint selection and help ensure that when trials demonstrate promising outcomes, those results translate smoothly into regulatory approval.
2. How should iBCI clinical trial populations be defined – by disease/injury or function/impairment?
During the approval process, regulators must determine what populations a given iBCI is indicated for (i.e., “indications for use”), a decision that is informed by clinical trial design and will directly impact eligibility, access, and reimbursement. Typically, indications for use are defined by diagnosis (e.g., ALS, SCI, stroke). For iBCIs, this approach risks excluding individuals with the same functional impairments but different etiologies, particularly those with rare conditions. A shift toward functional indications for use would prioritize the functional need iBCIs address, enabling more equitable access for those with severe motor or communication impairment, regardless of underlying diagnosis. Clinician input on this topic will help determine a robust approach that is conducive to uptake by regulators.
This workshop will share draft frameworks and invite feedback through guided discussion from PTs, OTs, SLPs, physiatrists, and neurologists, ensuring that how we measure iBCI benefit and how we define eligible populations both reflect the lived goals of the people who will use these technologies and the clinicians who support their progress.
Note: If you have already registered for the ASNR 2026 Annual Meeting and want to attend this workshop, please do not click on the Register Now button. Instead, visit www.asnr.com/asnr2026/add-workshop for step-by-step instructions on how to add the workshop to your existing registration.






