Recruiting

Thalamus Seizure Detection

Sponsor:

Mayo Clinic

Code:

NCT06700356

Conditions

Epilepsy; Seizure

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Phase 1-Validation of thalamus seizure detection with concurrent video EEG monitoring

Phase 2-DBS Stimulation with Medtronic Percept DBS device-Out Patient

Study Details

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

Study ID

NCT06700356

Start date

Jul 1, 2026

Status verified date

Jul, 2026

Completion date

May, 2027

Anticipated

Primary completion date

Nov, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

5 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Thalamus seizure detection with a DBS system

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

Interventions

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.

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).

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Karla Crockett

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

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Principal Investigator:

Nicholas M Gregg

More Information

Sponsor

Mayo Clinic

Last update posted

Jul 13, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-07-13.