Gregory Worrell
The purpose of this research study is to determine the safety and effectiveness of the investigational Cadence Biomarker Targeted Stimulation (BTS) System (Model 5100 EEG Workstation and Alera Model 2000 Biomarker Stimulation System), when used to reduce the frequency of seizures in patients with generalized onset epilepsy.
This prospective, randomized, sham-controlled study will evaluate the safety, feasibility, and clinical effectiveness of the investigational Cadence Biomarker Targeted Stimulation (BTS) System in adults with drug-resistant generalized epilepsy. The study will enroll 10 adult participants (≥18 years of age) across participating Mayo Clinic sites. The Cadence BTS System is designed to provide deep brain stimulation (DBS) and record brain electrical activity. The system includes the Model 5100 EEG Workstation and the Alera implantable neural stimulation and recording system. Participants will un…
Inclusion Criteria: * Generalized-onset seizures. * Failure of at least two appropriately selected and adequately dosed anti-seizure medications. * Distinct, stereotyped seizures that the participant or caregiver can reliably count. * Ability, independently or with a competent assistant, to maintain a seizure diary and use the BTS System. * Stable anti-seizure medication doses and ketogenic diet, if applicable, for 1 month before enrollment, except acute intermittent benzodiazepine use. * At least 3 disabling seizures per month on average. Seizures separated by less than 8 hours are counted a…
The implanted Cadence BTS System is programmed so that no therapeutic MD stimulation is delivered during the 3-month sham period. Optimized centromedian nucleus thalamus (CM) stimulation continues. This intervention is administered once to every participant in the period specified by the assigned sequence.
The implanted Cadence BTS System delivers protocol-defined low-frequency stimulation to the bilateral MD thalamic nuclei for 3 months while optimized CM stimulation continues. This intervention is administered once to every participant in the period specified by the assigned sequence.
The implanted Cadence BTS System delivers protocol-defined high-frequency stimulation to the bilateral MD thalamic nuclei for 3 months while optimized CM stimulation continues. This intervention is administered once to every participant in the period specified by the assigned sequence.
After the randomized periods, all participants enter an open-label phase and receive the stimulation settings selected as optimal.
Arctuva estimate
Actual pay is set by the research site.
Verify or correct the compensation shown for this listing.