Neurophysiologically Based Brain State Tracking and Modulation in Focal Epilepsy

Not Applicable

Active, not recruiting

• Conditions: Epilepsy
• Interventions: Device: Medtronic Summit System, Olympus

• Registration Number: NCT03946618
• Lead Sponsor: Mayo Clinic

Brief Summary

Researchers are trying to determine if tracking seizure occurrence, seizure probability, behavioral state, cognition, and mood can be achieved using an implantable brain sensing and stimulation device (Medtronic RC+S Summit) coupled to an external, handheld, patient assistant device (PAD) with capability for patient interaction (patient data input). The system (RC+S \& PAD) provides intracranial EEG (iEEG) sensing, electrical brain stimulation, and machine learning algorithms running on the RC+S and PAD that will be coupled with electrical brain stimulation (EBS) to prevent seizures and improve quality of life in patients with epilepsy.

Detailed Description

This study will include patients with dominant temporal lobe epilepsy and bilateral temporal lobe epilepsy. The plan is to have 10 patients take part in this study at Mayo Clinic Rochester.

Study Timeline

• Study Start: 2019-01-18
• Study First Submitted: 2019-04-19
• Study First Submitted QC: 2019-05-09
• Study First Posted: 2019-05-10
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-05
• Last Update Posted: 2025-03-10
• Primary Completion: 2027-02
• Study Completion: 2027-02

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Epilepsy	Medtronic Summit System, Olympus	Patients with dominant temporal lobe epilepsy and bilateral temporal lobe epilepsy

Primary Outcome Measures

Name	Time	Method
Tracking cognition	Baseline, biweekly for up to 15 months	Measured using free recall task
Change in mood	Baseline, biweekly for up to 15 months	Measured using daily mood and anxiety trackers questionnaire, where 1 is not at all and 7 is extremely
Adverse events (AE) experienced with the RC+S system	Through 15 months	Number of AEs reported
24/7 continuous iEEG monitoring	Through 15 months	Number of RC+S systems that generates continues 24/7 EEG without interruption
Change in anxiety	Baseline, biweekly for up to 15 months	Measured using anxiety Generalized Anxiety Disorder 7-item (GAD-7) scale, where 0 is not at all sure and 3 is nearly every day

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States