Deep Brain Stimulation for Epilepsy
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
Gregory Worrell, MD, PhD
Principal Investigator
Mayo Clinic
Are You a Good Fit for This Trial?
This trial is for people with generalized onset epilepsy who are looking for new ways to reduce their seizure frequency. Participants should meet specific medical criteria set by the study team and not have conditions that would make deep brain stimulation unsafe.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Cadence Biomarker Targeted Stimulation (BTS) System
Trial Overview
Researchers are testing different types of electrical stimulation delivered to a part of the brain called the mediodorsal thalamus, using an investigational device, to see if it helps control seizures better than a sham (inactive) treatment.
How Is the Trial Designed?
6
Treatment groups
Experimental Treatment
All participants receive four deep brain stimulation leads implanted bilaterally in the centromedian (CM) and mediodorsal (MD) thalamic nuclei. After CM stimulation is optimized, participants complete three blinded, randomized 3-month periods of MD stimulation-sham, low frequency, and high frequency-in a participant-specific sequence while optimized CM stimulation continues. Participants then enter an open-label phase and receive the stimulation settings selected as optimal based on the randomized periods.
All participants receive four deep brain stimulation leads implanted bilaterally in the centromedian (CM) and mediodorsal (MD) thalamic nuclei. After CM stimulation is optimized, participants complete three blinded, randomized 3-month periods of MD stimulation-sham, low frequency, and high frequency-in a participant-specific sequence while optimized CM stimulation continues. Participants then enter an open-label phase and receive the stimulation settings selected as optimal based on the randomized periods.
All participants receive four deep brain stimulation leads implanted bilaterally in the centromedian (CM) and mediodorsal (MD) thalamic nuclei. After CM stimulation is optimized, participants complete three blinded, randomized 3-month periods of MD stimulation-sham, low frequency, and high frequency-in a participant-specific sequence while optimized CM stimulation continues. Participants then enter an open-label phase and receive the stimulation settings selected as optimal based on the randomized periods.
All participants receive four deep brain stimulation leads implanted bilaterally in the centromedian (CM) and mediodorsal (MD) thalamic nuclei. After CM stimulation is optimized, participants complete three blinded, randomized 3-month periods of MD stimulation-sham, low frequency, and high frequency-in a participant-specific sequence while optimized CM stimulation continues. Participants then enter an open-label phase and receive the stimulation settings selected as optimal based on the randomized periods.
All participants receive four deep brain stimulation leads implanted bilaterally in the centromedian (CM) and mediodorsal (MD) thalamic nuclei. After CM stimulation is optimized, participants complete three blinded, randomized 3-month periods of MD stimulation-sham, low frequency, and high frequency-in a participant-specific sequence while optimized CM stimulation continues. Participants then enter an open-label phase and receive the stimulation settings selected as optimal based on the randomized periods.
All participants receive four deep brain stimulation leads implanted bilaterally in the centromedian (CM) and mediodorsal (MD) thalamic nuclei. After CM stimulation is optimized, participants complete three blinded, randomized 3-month periods of MD stimulation-sham, low frequency, and high frequency-in a participant-specific sequence while optimized CM stimulation continues. Participants then enter an open-label phase and receive the stimulation settings selected as optimal based on the randomized periods.
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Who Is Running the Clinical Trial?
Gregory Worrell
Lead Sponsor
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