Epilepsy; Seizure
Conditions
Brief summary
The purpose of this study is to determine the feasibility of chronic ambulatory thalamus seizure detection. The sensitivity, specificity, and false alarm rate of thalamus seizure detection will be calculated using recordings from a deep brain stimulation system, assessed relative to concurrent gold-standard video-EEG monitoring collected in the in-patient setting (epilepsy monitoring unit), in 5 patients with drug resistant epilepsy.
Interventions
DEVICEPhase 1-Validation of thalamus seizure detection with concurrent video EEG monitoring
Epilepsy monitoring unit evaluation will follow standard of care practices for seizure characterization, and antiseizure medications may be reduced to facilitate the recording of seizures. Patient clinical management, and video-EEG interpretation will be completed by the clinical epilepsy monitoring unit team which consists of physicians, nurse practitioners, registered nurses, and in-house 24-hour 7-days-per-week EEG technicians. Continuous full-bandwidth thalamus recordings (250 Hz) will be acquired by the research study team using a standard clinician programmer and telemetry module. Hospital monitoring will last up to 4 days.
DEVICEPhase 2-DBS Stimulation with Medtronic Percept DBS device-Out Patient
Patients will then transition to the ambulatory phase. In the outpatient setting, patients will have constrained ambulatory thalamus recordings using recording parameters determined by Phase 1. DBS treatment stimulation will be programmed in the clinical epilepsy neuromodulation lab using typical high frequency (\>50 Hz) stimulation. High frequency stimulation is the conventional approach to DBS for epilepsy, as was used in the pivotal study leading to premarket approval (SANTE study)2 of anterior nucleus of the thalamus (ANT) DBS for focal epilepsy, which is typical for epilepsy DBS practice3, and several studies of DBS for generalized epilepsy4-6, in a sensing friendly electrode configuration. Patients will keep a detailed seizure diary. Ambulatory thalamus recordings by the DBS system and patient reported seizure diaries will be collected during routine clinical DBS programming visits (q3-9 months).
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Participants must meet all of the inclusion criteria to participate in this study: * 18 years of age and older. * Implanted with a clinical DBS system for epilepsy with brain recording capabilities (Medtronic Percept™ DBS). * Subject or legally authorized representative is able to understand study procedures and to comply with them for the entire length of the study.
Exclusion criteria
All candidates meeting any of the
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Thalamic seizure detection in the epilepsy monitoring unit | 2 years | The sensitivity, specificity, and false alarm rate of thalamus seizure detection will be calculated using recordings from a deep brain stimulation system, assessed relative to concurrent gold-standard video-EEG monitoring collected in the epilepsy monitoring unit, in patients with drug resistant epilepsy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ambulatory thalamus seizure detection with constrained DBS recordings | 2 years | The sensitivity, specificity, and false alarm rate of chronic ambualtory thalamus seizure detection will be calculated using constrained local field potential power-in-band recordings from a deep brain stimulation system, assessed relative to patient reported seizure diary. |
Countries
United States
Contacts
CONTACTKarla Crockett
PRINCIPAL_INVESTIGATORNicholas Gregg
Mayo Clinic
Outcome results
None listed