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

University of Minnesota (UMN)

Status and phase: Enrolling; Early Phase 1

Conditions: Deep Brain Stimulation; Refractory Epilepsy

Treatments: Other: PS and OS stimulation order 3; Other: PS and OS stimulation order 1; Other: PS and OS stimulation order 2

Study type: Interventional

Funder types: Other

Identifiers

NCT05493722

NEUROSURG-2021-29636

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• severe dementia at investigator discretion

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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20 participants in 3 patient groups

Stimulation Group A

Experimental group

Description:

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

Treatment:

Other: PS and OS stimulation order 1

Stimulation Group B

Experimental group

Description:

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

Treatment:

Other: PS and OS stimulation order 2

Stimulation Group C

Experimental group

Description:

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

Treatment:

Other: PS and OS stimulation order 3