Recruiting NCT06700356

Thalamus Seizure Detection With a Deep Brain Stimulator System

No phase Interventional Epilepsy; Seizure

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Phase 1-Validation of thalamus seizure detection with concurrent video EEG monitoring, Phase 2-DBS Stimulation with Medtronic Percept DBS device-Out Patient.
Who it may be relevant to: Registry conditions: Epilepsy; Seizure. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Seizure Detection With a Deep Brain Stimulation System

Overview

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

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 ac
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 anteri

Primary outcome measures

Thalamic seizure detection in the epilepsy monitoring unit [Time frame: 2 years]

Secondary outcome measures (1)

Ambulatory thalamus seizure detection with constrained DBS recordings [Time frame: 2 years]

Eligibility criteria

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 exclusion criteria at baseline will be excluded from study participation:

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: N/A
Model: Single group
Masking: Open label
Primary purpose: Basic science

Study locations

United States · 1 center

Mayo Clinic in Rochester — Rochester

Identifiers

NCT: NCT06700356 · 23-012058

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗