Thalamus Seizure Detection With a Deep Brain Stimulator System

NCT06700356 | Recruiting FDA Device

• 1 other identifier: 23-012058
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Epilepsy; Seizure

Outcome Measures

Primary Outcomes (1)

• 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.

  2 years

Secondary Outcomes (1)

• Ambulatory thalamus seizure detection with constrained DBS recordings

  2 years

Study Arms (1)

Thalamus seizure detection with a DBS system

EXPERIMENTAL

Thalamus seizure detection by a DBS system, validated with concurrent in-hospital gold standard video EEG monitoring.

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

Interventions

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).

Thalamus seizure detection with a DBS system

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.

Thalamus seizure detection with a DBS system

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Nicholas Gregg

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karla Crockett

CONTACT

507-538-4880; crockett.karla@mayo.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 20, 2024
• First Posted: November 22, 2024
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)