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

Physician-Selected Settings Stimulation

Optimized Settings Stimulation

DBS Setting Optimization

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

Jul 1, 2021

Status verified date

Oct, 2026

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

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: PS, OS, OS Stimulation Sequence

Participants with electrodes in the anterior nucleus of the thalamus will receive physician-selected settings stimulation for 4 months, followed by optimized settings stimulation for 8 months.

experimental: OS, PS, OS Stimulation Sequence

Participants with electrodes in the anterior nucleus of the thalamus will receive optimized settings stimulation for 4 months, followed by physician-selected settings stimulation for 4 months, then optimized settings stimulation for 4 months.

experimental: OS, OS, PS Stimulation Sequence

Participants with electrodes in the anterior nucleus of the thalamus will receive optimized settings stimulation for 8 months, followed by physician-selected settings stimulation for 4 months.

experimental: Non-Anterior Thalamic Electrode Location

Participants with electrodes in a thalamic location other than the anterior nucleus of the thalamus will undergo setting optimization but will not be randomized to the three stimulation-order groups.

Interventions

Physician-Selected Settings Stimulation

Participants will receive deep brain stimulation using physician-selected settings

Optimized Settings Stimulation

Participants will receive deep brain stimulation using optimized settings determined through setting optimization.

DBS Setting Optimization

Participants with electrodes in a thalamic location other than the anterior nucleus of the thalamus will undergo deep brain stimulation setting optimization but will not be randomized to one of the three stimulation-sequence groups.

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

Anusha Duggirala

612-624-3672duggi008@umn.edu

Locations

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55455

Contacts

Anusha Duggirala

612-624-3672duggi008@umn.edu

More Information

Sponsor

University of Minnesota

Last update posted

Oct 16, 2026

Last verified

Oct, 2026

Keywords

  • Refractory Epilepsy
  • deep brain stimulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-24. This information was provided to ClinicalTrials.gov by University of Minnesota on 2026-10-16. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.