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

Part of paid clinical trials in Minneapolis, Minnesota.

Sponsor
University of Minnesota
Study ID
NCT05493722
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • Deep Brain Stimulation
  • Refractory Epilepsy

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • PS and OS stimulation order 1 — OTHER
    PS, OS, OS
  • PS and OS stimulation order 2 — OTHER
    OS, PS, OS
  • PS and OS stimulation order 3 — OTHER
    OS, OS, PS

Study Details

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.

Key Dates

Start date
Sep 15, 2023
Status verified
Oct 2025
Primary completion
Jan 15, 2028
Completion
Jan 15, 2030

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

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.

Primary Outcome Measure

Difference in broadband power with different settings [ Time Frame: One year from baseline ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MinnesotaMinneapolisMinnesota55455
Alec Jonason
[email protected]
612-624-3127

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By research site
University of Minnesota· Minneapolis, MN

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