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Recruiting NCT05493722

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

Early Phase I Interventional Refractory Epilepsy Deep Brain Stimulation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: PS and OS stimulation order 1, PS and OS stimulation order 2, PS and OS stimulation order 3.
Who it may be relevant to
Registry conditions: Refractory Epilepsy, Deep Brain Stimulation. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Other PS and OS stimulation order 1
    PS, OS, OS
  • Other PS and OS stimulation order 2
    OS, PS, OS
  • Other PS and OS stimulation order 3
    OS, OS, PS

Primary outcome measures

  • 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]
Secondary outcome measures (3)
  • Identify all seizures [Time frame: one year from baseline]
  • Scores on Montreal Cognitive Assessment, MoCA [Time frame: one year from baseline]
  • Scores on epilepsy-specific quality of life questionnaire (QOLIE-10P) [Time frame: One year from baseline]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • severe dementia at investigator discretion

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Single group
Masking
Double blind
Primary purpose
Supportive care

Study locations

United States · 1 center
  • University of Minnesota — Minneapolis

Identifiers

NCT: NCT05493722 · NEUROSURG-2021-29636

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗