1. Monitoring Devices: What to Know & What to Ask November 12, 2016
Tom Stanton / Executive Director / Danny Did Foundation / DannyDid.org
Give a brief overview of Danny and the DDF.
Epilepsy Foundation of Greater Chicago Conference

2. Discussion Overview
How monitoring devices can fit into a treatment plan
Setting the right expectations
Questions a family may ask their doctor and the device manufacturer
EFGC 2016 Consumer Conference

3. Why Should a Patient/Family Consider a Device?
As an added layer of monitoring support
As a compliment to the medicinal, surgical or dietary treatments you utilize to treat seizures
As a means to enable early intervention when seizure activity occurs
If a parent or caretaker is present, they can take steps to make sure the person who had a seizure is breathing, uninjured, positioned safely, etc.
More than honing in on a specific device, I want to talk about the reasons that monitors can be an effective addition to your tool kit.
EFGC 2016 Consumer Conference

4. Setting Expectations: What Monitoring Devices Can’t Do
Most devices make no claim to prevent seizures from occurring, or that they can stop a seizure that is already underway
Many devices do not measure reliably for factors other than movement
No devices are clinically proven to prevent Sudden Death in Epilepsy (SUDEP)
EFGC 2016 Consumer Conference

5. Which Device Is the “Best” One?
Only a parent, caregiver or an adult with epilepsy can decide what’s best for their situation. Ideally this happens with the support and consultation of their doctor
A patient or parents should focus on the device option that addresses their greatest area of concern
If it is a wearable device, ask, will the child be comfortable to wear it?
Give examples – daytime versus sleep monitoring.
EFGC 2016 Consumer Conference

6. Device-Related Questions to Ask Your Doctor
Would monitoring for seizures help to keep my loved one safer?
Would you utilize additional data on seizure activity that a device could provide?
What time of day or night is most critical for monitoring?
Which of my child/loved one’s seizure types are the most important to monitor for?
Could using a pulse oximeter at home be helpful?
Is there any technology more comprehensive than a baby monitor that you know of or can recommend?
EFGC 2016 Consumer Conference

7. Questions To Ask a Device Manufacturer
Who is the target user for your device?
How is a caregiver alerted to seizure activity?
What is your product’s false/positive reliability rate, and is there published data that indicates the effectiveness of the device?
What type of seizures can your device detect?
Does it enable GPS functionality?
Does your device have a mechanism to share compiled data with a doctor?
Can the device track the length of a seizure?
What is the product warranty?
Are you seeking FDA-approval and if so, where are you in the process?

8. Cost and Insurance
What is the cost? Is it a one-time cost, or reoccurring?
For the insurance company: Do you cover the device in need?
Insurance coverage is sometimes achieved but still not typical
Most monitoring devices are not classified or marketed as medical devices
Patients and doctors pushing for more from insurance companies helps to sparks progress & change
Non-medical devices without FDA approval are less likely to receive insurance coverage.
EFGC 2016 Consumer Conference

9. Emfit Movement Monitor ($600)
Some Devices at Market
Emfit Movement Monitor ($600)
A Finnish company with a U.S. presence in
Austin, Texas
Clinically tested at LeBonheur Children’s in Memphis, Northwestern Memorial, and Rush, among others
Measures for consistent and repetitive movement and sounds an alert via an audible alarm
This product is marketed as a seizure monitor in parts of Europe, but not in the U.S.
THESE ARE NON INVASIVE OPTIONS, VERSUS IMPLANTED TREATMENTS LIKE VNS OR NeuroPace RNS (Responsive Neural Stimulation) System
EFGC 2016 Consumer Conference

10. Some Devices at Market Emfit QS ($325)
The newest product from Emfit Corp.
It stores sleep statistics, heart rate, respiration rate and movement activity to a cloud server
It can be used by itself or in companion with the Emfit Movement Monitor
Currently being tested in multiple clinical settings
It currently offers no alerting function, only data tracking
EFGC 2016 Consumer Conference

11. Some Devices at Market Sleep Activity Monitor SAMi ($349-$1,399)
A video based nighttime movement detection system.
Through software and an infrared camera, a parent or caregiver is alerted on their IOS device to unusual movement in the monitored location.
SAMi alarms on motion. The motion can be small and it does not need to be repetitive, but it must continue for at least 15 seconds.  
You can adjust the time before the alarm sounds, but less than 15 seconds results in more false alarms.
Manufactured by a company called HiPass Design.
*Note – only movement is being tracked so far
EDA = Electrodermal activity, or skin conductance
Added bonus – video can be shared with doctors
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12. Some Devices at Market Embrace wristwatch ($199)
A worn device that is designed to monitor for movement, skin perspiration and body temperature.
It’s aim is to track physiological stress, arousal, sleep and physical activity. Designed to learn from the user’s activity and adjust accordingly to improve performance.
Alerts are sent via a phone call.
There is a monthly fee in addition to the activation fee.
Manufactured by a company called Empatica.
Is being tested at multiple sites.
*Note – only movement is being tracked so far
EDA = Electrodermal activity, or skin conductance
Developed by Rosalind Picard at the MIT Media Lab
EFGC 2016 Consumer Conference

13. Some Devices at Market SmartWatch ($99-$150)
A wristwatch worn device that is designed to monitor for repetitive shaking motions.
Can be used to monitor during the day or during sleep.
It sends alert notifications via a text message and a phone call.
There is a monthly fee in addition to the activation fee.
Manufactured by a company called Smart-Monitor.
EFGC 2016 Consumer Conference

14. Some Devices at Market Sleep-Safe Anti-Suffocation Pillow ($150)
Designed to help prevent fatal suffocation events during sleep seizures occurring in domestic or care settings
Developed by a pharmacist in the United Kingdom whose son has nocturnal seizures
Is registered as a medical device in the U.K.
No U.S.-based trials or data
A LOW TECH RESOURCE. OTHER EXAMPLES INCLUDE THE “SAFETY PLACE MAT”
EFGC 2016 Consumer Conference

15. EFGC 2016 Consumer Conference
What’s Coming Next?
An increase in ‘multi-module’ devices that measure for more factors than just movement, for example, heart rate, respiration and skin conductance
Most store data on the cloud for access and viewing by the patient’s doctor
Technology in which the device conducts the intervention itself, instead of simply alerting to activity
THIS IS A CATEGORY THAT IS RELATIVELY NEW. THE RESOURCES WILL ONLY BECOME MORE SOPHISTICATED IN TIME.
EFGC 2016 Consumer Conference

16. Danny Did’s Advice to Families
Start broadly in your device research and hone in on the option that works best for your situation.
Solicit input from your doctor, ask other parents for feedback, and seek published data.
Remember: You are your loved one’s best advocate – trust yourself and don’t give up!
CHECK FOR REMAINING TIME
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17. Danny Did Ad in Neurology Today  The Best Source for SUDEP Information is a Patient’s Doctor *brochures available
TIME PERMITTING

18. Devices In the Pipeline
PROGUARDIAN REST by Cyberonics
Measures heart rate and movement during sleep
The user wears a patch on their chest for up to 12 hours
For home use
Clinical trials are underway
Is seeking FDA approval
TIME PERMITTING
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19. Devices In the Pipeline
BRAIN SENTINEL by Brain Sentinel Inc.
Effort led by Dr. Jose Cavazos of the University of Texas-San Antonio
Device is worn on the arm and designed to detect convulsive seizures during at home use
100 person study at 11 centers is underway
Seeking FDA approval
TIME PERMITTING
EFGC 2016 Consumer Conference

20. Devices In the Pipeline
EPOCH WIRELESS EEG PATCH by Epitel Inc.
Mobile EEG recording
A worn patch attached to the scalp
Developed at the University of Utah
Logs and records EEG data for 3-days (their goal is 7 days)
Designed for one-time use
Sales and distribution partner is Ripple
TIME PERMITTING

21. Devices In the Pipeline
ESAP by RTI International
A worn device that measures for movement, heart rate, body temperature and respiration
A prototype is being developed under a $1.6 million grant from the NIH
Aims to detect a range of seizure types
Its algorithm develops over time based on the user’s activity
Seeking a partner to market and own the device
TIME PERMITTING