Thalamus Seizure Detection With a Deep Brain Stimulator System

ConditionEpilepsy; Seizure

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorMayo Clinic

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Health status or any clinical conditions (e.g., life expectancy, co-existing disease) that, in the opinion of the site investigator, would pose undue risk to undergo epilepsy monitoring unit evaluation for the purpose of seizure characterization.

Women will verify not pregnant, and if applicable, have urine pregnancy test.

Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.

Inability or unwillingness of individual or legal guardian/representative to give written informed consent.

Trial design

Design model

Single group

Treatments tested in this trial

Phase 1-Validation of thalamus seizure detection with concurrent video EEG monitoring
Device
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.
Phase 2-DBS Stimulation with Medtronic Percept DBS device-Out Patient
Device
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).

Treatment groups

5 Participants

are divided into 1 treatment group

Group A: Thalamus seizure detection with a DBS systemExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

Thalamic seizure detection in the epilepsy monitoring unit

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.

Time frame

2 years

Secondary outcomes

Ambulatory thalamus seizure detection with constrained DBS recordings

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.

Time frame

2 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mayo Clinic

Lead sponsor

Source ClinicalTrials.gov

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