Recruiting
Early Phase 1

Deep Brain Stimulation

Sponsor:

University of Minnesota

Code:

NCT05493722

Conditions

Refractory Epilepsy

Deep Brain Stimulation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

PS and OS stimulation order 1

PS and OS stimulation order 2

PS and OS stimulation order 3

Study Details

Brief summary:

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.

Conditions

Refractory Epilepsy

Deep Brain Stimulation

Study ID

NCT05493722

Start date

Sep 15, 2023

Status verified date

Oct, 2025

Completion date

Jan 15, 2030

Anticipated

Primary completion date

Jan 15, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • severe dementia at investigator discretion

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Stimulation Group A

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

experimental: Stimulation Group B

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

experimental: Stimulation Group C

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

Interventions

PS and OS stimulation order 1

PS, OS, OS

PS and OS stimulation order 2

OS, PS, OS

PS and OS stimulation order 3

OS, OS, PS

Primary outcome measure

  • Difference in broadband power with different settings [ Time Frame: One year from baseline ]
  • Difference in frequency band-specific low-frequency power (LFP) with different settings [ Time Frame: One year from baseline ]

Central Contacts and Locations

Central contacts

Alec Jonason

612-624-3127jonas074@umn.edu

Locations

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55455

Contacts

Alec Jonason

612-624-3127jonas074@umn.edu

More Information

Sponsor

University of Minnesota

Last update posted

Oct 24, 2025

Last verified

Oct, 2025

Keywords

  • Refractory Epilepsy
  • deep brain stimulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Minnesota on 2025-10-24.