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Neural Stimulator

DBS Parameter Optimization for Epilepsy

Phase < 1
Recruiting
Led By Robert McGovern, MD
Research Sponsored by University of Minnesota
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one year from baseline
Awards & highlights
No Placebo-Only Group

Summary

This trial will develop a platform for more effective deep brain stimulation (DBS) for epilepsy by optimizing the INS settings for each patient based on power spectral density measures.

Who is the study for?
This trial is for patients with epilepsy that doesn't respond to medication and who already have a deep brain stimulator implanted. It's not suitable for individuals with severe dementia as determined by the study investigator.
What is being tested?
The study tests how changing settings on an implantable neural stimulator can better control seizures in epilepsy patients. Different orders of stimulation (PS and OS) are being compared to find the most effective parameter adjustments.
What are the potential side effects?
While specific side effects aren't listed, deep brain stimulation may cause headache, dizziness, change in mood or behavior, speech problems, or unintended movements.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one year from baseline
This trial's timeline: 3 weeks for screening, Varies for treatment, and one year from baseline for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Difference in broadband power with different settings
Difference in frequency band-specific low-frequency power (LFP) with different settings
Secondary study objectives
Identify all seizures
Scores on Montreal Cognitive Assessment, MoCA
Scores on epilepsy-specific quality of life questionnaire (QOLIE-10P)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Group I: Stimulation Group CExperimental Treatment1 Intervention
Participants with already implanted DBS will receive stimulation order 1. OS, OS, PS.
Group II: Stimulation Group BExperimental Treatment1 Intervention
Participants with already implanted DBS will receive stimulation order 1. OS, PS, OS.
Group III: Stimulation Group AExperimental Treatment1 Intervention
Participants with already implanted DBS will receive stimulation order 1. PS, OS, OS.

Find a Location

Who is running the clinical trial?

University of MinnesotaLead Sponsor
1,434 Previous Clinical Trials
1,621,682 Total Patients Enrolled
Robert McGovern, MDPrincipal InvestigatorUniversity of Minnesota

Media Library

Implantable Neural Stimulators (INSs) (Neural Stimulator) Clinical Trial Eligibility Overview. Trial Name: NCT05493722 — Phase < 1
Deep Brain Stimulation Research Study Groups: Stimulation Group C, Stimulation Group A, Stimulation Group B
Deep Brain Stimulation Clinical Trial 2023: Implantable Neural Stimulators (INSs) Highlights & Side Effects. Trial Name: NCT05493722 — Phase < 1
Implantable Neural Stimulators (INSs) (Neural Stimulator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05493722 — Phase < 1
~13 spots leftby Jan 2028
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