Thalamus Seizure Detection With a Deep Brain Stimulator System

Conditions

• Epilepsy; Seizure

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 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).

Study Details

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.

Key Dates

Start date

Jun 1, 2026

Status verified

Mar 2026

Primary completion

Nov 30, 2026

Completion

May 31, 2027

Study Design

Enrollment

5 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

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.

Primary Outcome Measure

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

Central Contacts

• Karla Crockett
  507-538-4880
  [email protected]

Locations (1)

Find similar trials in Rochester, MN

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