FDA/NIH Joint Workshop: Developing Implanted Brain-Computer Interface Clinical Outcome Assessments to Demonstrate Benefit

September 19, 2024 | 8:30 - September 20, 2024 | 12:00
ET
https://www.surveymonkey.com/r/BCIClinicalAssessments

The Food and Drug Administration (FDA) and National Institutes of Health (NIH) are announcing a public workshop to engage with stakeholders in the implanted brain-computer interface device ecosystem. The purpose of the workshop is to discuss the development of clinical outcome assessments (COAs) to evaluate the effectiveness of implanted brain-computer interfaces (BCIs). The Implanted BCI devices that are focus of this workshop are neuroprostheses that interface with the central nervous system to restore lost motor and/or sensory capabilities in people with impairments in motor function and/or communication. Visit the event website for more details.

The public workshop will be webcasted. Register to receive the link to the webcast in a confirmation email. After the live webcast, a link for the recorded co-sponsored public workshop will be posted to the FDA webpage.

FDA/NIH Joint Workshop: Developing Implanted Brain-Computer Interface Clinical Outcome Assessments to Demonstrate Benefit

This public workshop will be held September 19, 2024, from 8:30 a.m. to 5:00 p.m. and September 20, 2024, from 8:30 a.m. to 12:00 p.m. (ET) at the following location:

FDA White Oak Campus 
10903 New Hampshire Avenue 
Bldg. 31, Room 1503 (the Great Room) 
Silver Spring, MD, 20993

Register Now!

The following co-sponsored public workshop agenda is preliminary and subject to change. More information will be made available as presenters are confirmed. 

Agenda

September 19th, 2024

TimeSubjectName of Speaker/
8:30-8:45WelcomeDavid McMullen, MD (FDA)
John Ngai, PhD (NIH)
8:45-9:00 Emerging implanted BCI technologies state of development   
9:00-9:30Intro to Clinical Outcome Assessments (COAs)  
9:30-10:15 The current state of COA in payor’s coverage decision making  
10:15-10:30Break
10:30-11:15The current state of COA in evaluating people with functional impairments 
11:15-11:30Systematic Review of Clinical Outcome Assessments (COAs) for Communication Brain-Computer Interface Devices (cBCIs) in Amyotrophic Lateral Sclerosis (ALS) grant update 
11:30-12:30Lunch
12:30-1:00Patient PerspectivePatient panel
1:00-1:30 

Task Setting for Breakout Rooms

  • What are the gaps in COAs?
  • How should Performance Outcome Measures be used?
  • Should there be a universally applicable assessment or a toolbox of various COAs?
FDA and NIH
1:30-3:30

Breakout rooms based on indication

  • Communication (e.g., language, speech, tablet use for communication)
  • Activities of daily living (including upper limb function)
  • Mobility (e.g., ambulation with lower limb prosthesis or exoskeleton, wheelchair use)
3:30-4:30Report back from Breakout RoomsBreakout groups to present their discussion
4:30-5:00  Closing RemarksFDA and NIH

September 20th, 2024

TimeSubjectName of Speaker/
8:30-8:45 WelcomeHeather Dean, PhD (FDA)
Walter Koroshetz, MD (NINDS)
8:45-9:15From COAs to OPCs: How COAs can inform the next generation of BCI Clinical Trial DesignDavid McMullen, MD (FDA)
9:15-9:45  From clinical trials to home: how can NIH support a sustainable eco-system for better BCI COA development and BCI adoption in treating neurological conditionsNIH
9:45-10:45  Breakout rooms based on indications to revisit the previous discussions and re-evaluate responses to the prompts.
10:45-11:30   Report back from Breakout RoomsBreakout groups to present their discussion
11:30-12:00Workshop concluding remarks and next stepsFDA and NIH