Actively Recruiting
Optimization of Deep Brain Stimulation Parameters in Patients With Medically Refractory Epilepsy
Led by University of Minnesota · Updated on 2025-10-24
20
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying deep brain stimulation (DBS) in patients with medically refractory epilepsy who are not candidates for surgical removal of brain tissue. This early phase 1 trial aims to develop a personalized platform for optimizing DBS settings based on power spectral density (PSD) measures to potentially improve seizure control. Although DBS has been shown to reduce seizures, achieving complete seizure freedom remains rare, motivating this research. Participants already implanted with a DBS device will be randomly assigned to one of three groups, each receiving different orders of stimulation settings labeled PS and OS. Each participant will experience all three stimulation orders in varying sequences during the study. This approach allows researchers to compare the effects of different DBS parameter schedules on brain activity. During the one-year study, participants will be monitored for changes in brain broadband power and specific low-frequency power under different DBS settings. Researchers will also track seizure occurrences and assess cognitive function using the Montreal Cognitive Assessment (MoCA) and quality of life with an epilepsy-specific questionnaire (QOLIE-10P). The study includes double masking to reduce bias and will assess outcomes at one year from baseline.
CONDITIONS
Brief Title
Optimization of Deep Brain Stimulation Parameters in Patients With Medically Refractory Epilepsy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Medically refractory epilepsy
- Already have a deep brain stimulator implanted
- Age 18 years or older
You will not qualify if you...
- Severe dementia at investigator discretion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 1 year
Participants with an already implanted deep brain stimulator receive different sequences of stimulation settings to optimize parameters for epilepsy management.
Regular visits during the 1-year stimulation period
Trial Site Locations
Total: 1 location
1
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
Research Team
A
Alec Jonason
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
3
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here