NCT05493722 Optimization of Deep Brain Stimulation Parameters in Patients With Medically Refractory Epilepsy
| NCT ID | NCT05493722 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | University of Minnesota |
| Condition | Refractory Epilepsy |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2023-09-15 |
| Primary Completion | 2028-01-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 20 participants in total. It began in 2023-09-15 with a primary completion date of 2028-01-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * medically refractory epilepsy * already have a deep brain stimulator in place Exclusion Criteria: * severe dementia at investigator discretion
Contact & Investigator
Robert McGovern, MD
PRINCIPAL INVESTIGATOR
University of Minnesota
Frequently Asked Questions
Who can join the NCT05493722 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Refractory Epilepsy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05493722 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05493722 currently recruiting?
Yes, NCT05493722 is actively recruiting participants. Contact the research team at jonas074@umn.edu for enrollment information.
Where is the NCT05493722 trial being conducted?
This trial is being conducted at Minneapolis, United States.
Who is sponsoring the NCT05493722 clinical trial?
NCT05493722 is sponsored by University of Minnesota. The principal investigator is Robert McGovern, MD at University of Minnesota. The trial plans to enroll 20 participants.
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