ARTIFACT NO MORE

A Tough Clinical Challenge

During clinical evaluations, neurologists do not have all the information that they would like to have when making treatment decision or evaluating success in achieving the therapy goal. Basic questions include:

• How many events is the patient having?
• What kind of events are they?
• What time of the day are the events?
• Is the event epileptic?
• Are the medications and treatment plan having the desired effect?

From A to B: Artifact to Biomarker

Brain Sentinel commissioned its prospective, multi-center, pivotal trial in eleven of the top Epilepsy Centers in the U.S., enrolling 199 patients. It compared the SparkSense^TM sEMG algorithm against the gold standard, video EEG (vEEG). In adult patients who had the sEMG monitor properly placed on the belly of the biceps, the SparkSense algorithm identified 21 of 21 generalized tonic-clonic seizures. Time to detect was calculated at 5.3 seconds making it the fastest and most reliable seizure alarm on the market.

Subsequent review of the sEMG data from Brain Sentinel’s clinical study revealed that the Tonic and Clonic phase lengths are similar between:

• Primary and Secondarily Generalized GTCS
• vEEG and sEMG calculations

In addition, 60% of the GTCS in the study fell between 9PM and 8AM (Data on file). This finding corresponds with what the literature reports when GTCS are most likely to occur and be unreported.

But, that’s not the end of the story…

Unique sEMG Event Signatures

Unlike motion sensors that can only report the presence of movement and its velocity, sEMG signals are statistically unique for different types of events. They can be measured, analyzed and interpreted. Further, the tonic and clonic phase characteristics can be independently analyzed. sEMG data can help a trained physician characterize:

• Typical Generalized Tonic-Clonic Seizure
• Typical Event of Interest with with a Motor Component

Harnessing the Power of the sEMG Biomarker

The SPEAC^® System enables patients and their motor seizures to be heard through a combination of ways:

• Longitudinal record for better seizure management
• Reflect motor cortices’ activation
• Helps rule in GTCS
• Helps a physician distinguish between GTC seizures and events of interest
• Helps a physician assess the impact of medications and treatment plans
• Provides a GTC seizure alarm during the monitoring period
• Contextualizes a single event detail with the sEMG wave and wavelet analyses, audio, post-ictal assessment and seizure diary information