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

StatusRecruiting
PhaseEarly Phase 1
Started
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Record History

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  1. Enrollment increased: 20 → 30 participants Show 5 more changesShow less
    • Interventions modified
    • Trial arms changed: 3 → 4
    • Start date: Sep 15, 2023 to Jul 1, 2021
    • Site contact updated
    • Eligibility criteria expanded, about 3 words
  2. 2 versions Re-verified since Oct 6, 2024, no change to tracked fieldsv5-v6
  3. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised
    v4
  4. Start date: Aug 1, 2023 to Sep 15, 2023
    • Primary completion date: Dec 1, 2027 to Jan 15, 2028
    • Study completion date: Dec 1, 2029 to Jan 15, 2030
    v3
  5. Re-verified, no change to tracked fieldsv2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05493722
Lead Sponsor University of Minnesota
Conditions
(from sponsor)		 Refractory Epilepsy, Deep Brain Stimulation
Related terms Drug Resistant Epilepsy
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov