NCT06700356 · Mayo Clinic
Thalamus Seizure Detection With a Deep Brain Stimulator System
What this study is about
The purpose of this study is to determine the feasibility of chronic ambulatory thalamus seizure detection.
View original scientific description
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 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).
Primary outcome measures
Thalamic seizure detection in the epilepsy monitoring unit
Time frame: 2 years
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Rochester, Minnesota
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 13, 2026 · Source of record for eligibility and locations