Optimization of Deep Brain Stimulation Parameters in Patients With Medically Refractory Epilepsy

NCT ID: NCT05493722

Last Updated: 2025-10-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-15

Study Completion Date

2030-01-15

Brief Summary

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Deep brain stimulation (DBS) is used to treat epilepsy in cases where patients are medically refractory and are not candidates for surgical resection. This therapy has been shown to be effective in seizure reduction, yet very few patients achieve the ultimate goal of seizure freedom. Implantable neural stimulators (INSs) have many parameters that may be adjusted, and could be tuned to achieve very patient specific therapies. This study will develop a platform for stimulation setting optimization based on power spectral density (PSD) measures.

Detailed Description

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Conditions

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Refractory Epilepsy Deep Brain Stimulation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Participants will be randomly assigned to a stimulation order at the baseline visit with optimized settings (OS) stimulation occurring for a total of 8 months and physician-selected settings (PS) stimulation chosen for a total of 4 months. For example, a patient may undergo PS setting stimulation from 4-8 months, then undergo OS setting stimulation from 8-12 and 12-16 months. Thus, there are three possible stimulation groups (1. PS, OS, OS; 2.OS, PS, OS; 3. OS, OS, PS).
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
A study coordinator who is blinded to the chosen stimulation setting will check the data daily to ensure the patient is wearing the device properly and recording seizure events. At each optimization visit, the MoCA and QOLIE-10P surveys will also be administered to the participants by a member of the research team who is blinded to the group the participant is assigned to.

Study Groups

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Stimulation Group A

Participants with already implanted DBS will receive stimulation order 1. PS, OS, OS.

Group Type EXPERIMENTAL

PS and OS stimulation order 1

Intervention Type OTHER

PS, OS, OS

Stimulation Group B

Participants with already implanted DBS will receive stimulation order 1. OS, PS, OS.

Group Type EXPERIMENTAL

PS and OS stimulation order 2

Intervention Type OTHER

OS, PS, OS

Stimulation Group C

Participants with already implanted DBS will receive stimulation order 1. OS, OS, PS.

Group Type EXPERIMENTAL

PS and OS stimulation order 3

Intervention Type OTHER

OS, OS, PS

Interventions

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PS and OS stimulation order 1

PS, OS, OS

Intervention Type OTHER

PS and OS stimulation order 2

OS, PS, OS

Intervention Type OTHER

PS and OS stimulation order 3

OS, OS, PS

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* medically refractory epilepsy
* already have a deep brain stimulator in place

Exclusion Criteria

* severe dementia at investigator discretion
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Minnesota

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robert McGovern, MD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

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University of Minnesota

Minneapolis, Minnesota, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Alec Jonason

Role: CONTACT

612-624-3127

Facility Contacts

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Alec Jonason

Role: primary

612-624-3127

Other Identifiers

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NEUROSURG-2021-29636

Identifier Type: -

Identifier Source: org_study_id

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