Cadence Neuroscience
This is a multicenter, prospective, controlled study designed to evaluate treatment with the BTS System.
Inclusion Criteria: 1. Subject is greater than or equal to 7 years of age. 2. Subject has focal onset seizures. 3. Subject has failed treatment with a minimum of two AED's used in typical therapeutic dosages. 4. Subject has seizures that are distinct, stereotypical events that can be reliably counted by the patient or caregiver. 5. Subject can reasonably be expected to maintain a seizure diary and the BTS System alone, or with the assistance of a competent individual. 6. For one month prior to enrollment, subject's anti-epileptic medication dosages and ketogenic diet (as applicable) have been…
Using continuous stimulation to target multiple network nodes, Biomarker Targeted Stimulation (BTS) is intended to suppress abnormal interictal activity, as determined by biomarkers including interictal epileptiform discharges (IED) and high frequency oscillations (HFO), with the intention to reduce brain hyperexcitability, thereby limiting seizure occurrence.
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