On June 2-3, 2011, the FDA hosted a workshop co-sponsored by three clinical professional societies - Academy of Neurology, American Epilepsy Society, and National Academy of Neuropsychology - to discuss issues related to the validation and labeling of devices used to assess seizures, cognitive function, traumatic brain injury (TBI) and Concussion. Over 200 people of various backgrounds attended the meeting, with clinicians, academicians/researchers, industry, and government (FDA, NIH and military) all represented.
On Day 1, six experts in all three fields presented a summary of the current clinical state of seizure detection, cognitive assessment and TBI/Concussion assessment. During a lunch-session, two speakers spoke about more specific TBI issues, and in the afternoon the attendees split into smaller breakout sessions of about ~30 people. In these breakout sessions, attendees informally discussed questions the workshop planning committee (comprised of clinicians from the three professional societies, invited clinicians and FDA) drafted prior to the meeting, while moderators (clinicians from the professional societies) directed the discussion. Questions were related to how validation studies for these devices should be designed and what type of information should be in the labeling to help users use the device safely and effectively. Discussions were productive and lively.
On Day 2 (a half day), the moderators from the three subgroups presented a summary of what was discussed in their breakout sessions and took questions from the audience. General consensus from all three groups included the following: event/disease to be detected should be clearly defined in the studies and labeling; clear definition of the users and environment of use are key to validation and labeling; performance results should be in labeling.
Overall feedback from attendees was that the workshop was a great first step toward establishing a dialogue between the different stakeholders and that there should be continued efforts toward providing guidelines for each area.
DISCLAIMER: The co-sponsors do not endorse any presentations, opinions or conclusions from this workshop.
Date and Location
This meeting was held on June 2-3, 2011, at
Food and Drug Administration
White Oak Campus
10903 New Hampshire Ave
Silver Spring, MD 20993
Final Meeting Agenda
June 2, 2011
General Session (Chair, Peter G. Como, Ph.D.):
8:00 – 8:10 am Introduction to workshop
William Maisel, M.D., M.P.H, Deputy Director for Science, CDRH
8:10 - 8:30 am Sara Aguel: “Introduction to Seizure Detection, Cognitive Function and
8:30 – 9:25 am Seizure Detection Software (2 speakers)
Brian Litt, M.D.: “Clinical Issues in the Diagnosis of Seizures and
Natalie Getzoff, M.D.: “Current Regulatory Pathways and Performance
Validation of Seizure Detection Devices”
9:25 – 10:25 am Current Practice of Cognitive Assessment (2 speakers)
Gordon Chelune, Ph.D.: “Traditional Cognitive Testing: History, Current
State and Psychometric Standardization Procedures”
10:25 – 10:40 am Break
10:40 – 11:45 am TBI / Sports Concussion Assessment (2 speakers):
Ruben Echemendia, Ph.D., “Overview of Computerized Cognitive
Instruments in the Assessment of TBI/Sports Concussion”
11:45 am - 12:00 pm Pick-up Bagged Lunch
Lunch Keynote Speakers (Chair, Peter G. Como, Ph.D.)
12:00 pm - 12:20 pm Glenn Cockerham, M.D., Chief of Ophthalmology, VA Palo Alto
Health Care System, “Visual Dysfunction associated with Traumatic Brain Injury”.
12:25 pm - 12:45 pm Captain Paul Hammer, M.D., Director, Defense Centers of
Excellence for Psychological Health and Traumatic Brain Injury,
“Issues in the Assessment of Traumatic Brain Injury in the Military”.
Breakout Sessions (Link to Breakout Questions)
12:45 – 1:00 pm Peter Como, Ph.D.: Instructions for Breakout Sessions
Move to Breakout Session rooms
1:00 – 4:30 pm Breakout Session Groups (includes break time, as determined by
4:30 pm End of Workshop for Attendees
4:30 - 4:45 pm Break for Workshop Planning Committee and Moderators
4:45 – 6:30 pm (Workshop Planning Committee and Moderators ONLY) – Summarize
consensus/majority/minority opinions heard in subgroup sessions; write
presentations for tomorrow.
Final Meeting Agenda
June 3, 2011
General Session Summary of Breakout Sessions to Entire Workshop
8:00 am – 8:05 am Introduction to Second Day (Peter Como, Ph.D.)
8:05 am - 8:50 am Summarize Breakout Session: Computerized Cognitive Assessment
(Russell Bauer Ph.D., ABPP/CN)
8:50 am – 9:05 am Discussion
9:05 am – 9:50 am Summarize Breakout Session: TBI/Sports Concussion (Jeff Kutcher,
9:50 am – 10:05 am Discussion
10:05 am – 10:15 am BREAK
10:15 am – 11:00 am Summarize Breakout Session: Seizure Detection (Brian Litt, M.D.)
11:00 am – 11:15 am Discussion Closing Comments from Co-Sponsors
11:15 am – 11:25 am American Academy of Neurology
11:25 am – 11:35 am American Epilepsy Society
11:35 am – 11:45 am National Academy of Neuropsychology
11:45 am – 11:55 am Food and Drug Administration