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

October 6, 2023 updated by: University of Minnesota
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Recruiting
        • University of Minnesota
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • severe dementia at investigator discretion

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Stimulation Group A
Participants with already implanted DBS will receive stimulation order 1. PS, OS, OS.
Other: PS and OS stimulation order 1
PS, OS, OS
Experimental: Stimulation Group B
Participants with already implanted DBS will receive stimulation order 1. OS, PS, OS.
Other: PS and OS stimulation order 2
OS, PS, OS
Experimental: Stimulation Group C
Participants with already implanted DBS will receive stimulation order 1. OS, OS, PS.
Other: PS and OS stimulation order 3
OS, OS, PS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in broadband power with different settings
Time Frame: One year from baseline
Different settings include different combinations of stimulation amplitude, frequency and pulse width. The full spectrum PSD data from all of the in-clinic recordings at all of the unique settings will be combined to look at the resulting difference in broadband power.
One year from baseline
Difference in frequency band-specific low-frequency power (LFP) with different settings
Time Frame: One year from baseline
Different settings include different combinations of stimulation amplitude, frequency and pulse width. The full spectrum PSD data from all of the in-clinic recordings at all of the unique settings will be combined to look at the resulting difference in frequency band-specific LFP.
One year from baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identify all seizures
Time Frame: one year from baseline
Detecting generalized tonic-clonic seizures using a wearable sensor wristband and patients-reported seizure activity.
one year from baseline
Scores on Montreal Cognitive Assessment, MoCA
Time Frame: one year from baseline
This is a brief cognitive assessment used to look at side effects of stimulation settings
one year from baseline
Scores on epilepsy-specific quality of life questionnaire (QOLIE-10P)
Time Frame: One year from baseline
This is a brief cognitive assessment used to look at side effects of stimulation settings
One year from baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Minnesota

Investigators

  • Principal Investigator: Robert McGovern, MD, University of Minnesota

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2023

Primary Completion (Estimated)

January 15, 2028

Study Completion (Estimated)

January 15, 2030

Study Registration Dates

First Submitted

August 5, 2022

First Submitted That Met QC Criteria

August 5, 2022

First Posted (Actual)

August 9, 2022

Study Record Updates

Last Update Posted (Estimated)

October 9, 2023

Last Update Submitted That Met QC Criteria

October 6, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NEUROSURG-2021-29636

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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