NCT06700356

Thalamus Seizure Detection With a Deep Brain Stimulator System

Seizure Detection With a Deep Brain Stimulation System

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (estimated)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Epilepsy; Seizure

Interventions

Type	Name	Description
DEVICE	Phase 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.
DEVICE	Phase 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).

Timeline

• Start date: 2026-06-01
• Primary completion: 2026-11-01
• Completion: 2027-05-01
• First posted: 2024-11-22
• Last updated: 2026-03-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study