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

Primary Purpose

Refractory Epilepsy, Deep Brain Stimulation

Status
Recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
PS and OS stimulation order 1
PS and OS stimulation order 2
PS and OS stimulation order 3
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Refractory Epilepsy focused on measuring Refractory Epilepsy, deep brain stimulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • severe dementia at investigator discretion

Sites / Locations

  • University of MinnesotaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Stimulation Group A

Stimulation Group B

Stimulation Group C

Arm Description

Participants with already implanted DBS will receive stimulation order 1. PS, OS, OS.

Participants with already implanted DBS will receive stimulation order 1. OS, PS, OS.

Participants with already implanted DBS will receive stimulation order 1. OS, OS, PS.

Outcomes

Primary Outcome Measures

Difference in broadband power with different settings
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.
Difference in frequency band-specific low-frequency power (LFP) with different settings
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.

Secondary Outcome Measures

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

Full Information

First Posted
August 5, 2022
Last Updated
October 6, 2023
Sponsor
University of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT05493722
Brief Title
Optimization of Deep Brain Stimulation Parameters in Patients With Medically Refractory Epilepsy
Official Title
Optimization of Deep Brain Stimulation Parameters in Patients With Medically Refractory Epilepsy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 15, 2023 (Actual)
Primary Completion Date
January 15, 2028 (Anticipated)
Study Completion Date
January 15, 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractory Epilepsy, Deep Brain Stimulation
Keywords
Refractory Epilepsy, deep brain stimulation

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Model Description
Participants will be randomly assigned to a stimulation order at the baseline visit with optimized settings (OS) stimulation occurring for a total of 8 months and physician-selected settings (PS) stimulation chosen for a total of 4 months. For example, a patient may undergo PS setting stimulation from 4-8 months, then undergo OS setting stimulation from 8-12 and 12-16 months. Thus, there are three possible stimulation groups (1. PS, OS, OS; 2.OS, PS, OS; 3. OS, OS, PS).
Masking
InvestigatorOutcomes Assessor
Masking Description
A study coordinator who is blinded to the chosen stimulation setting will check the data daily to ensure the patient is wearing the device properly and recording seizure events. At each optimization visit, the MoCA and QOLIE-10P surveys will also be administered to the participants by a member of the research team who is blinded to the group the participant is assigned to.
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Stimulation Group A
Arm Type
Experimental
Arm Description
Participants with already implanted DBS will receive stimulation order 1. PS, OS, OS.
Arm Title
Stimulation Group B
Arm Type
Experimental
Arm Description
Participants with already implanted DBS will receive stimulation order 1. OS, PS, OS.
Arm Title
Stimulation Group C
Arm Type
Experimental
Arm Description
Participants with already implanted DBS will receive stimulation order 1. OS, OS, PS.
Intervention Type
Other
Intervention Name(s)
PS and OS stimulation order 1
Intervention Description
PS, OS, OS
Intervention Type
Other
Intervention Name(s)
PS and OS stimulation order 2
Intervention Description
OS, PS, OS
Intervention Type
Other
Intervention Name(s)
PS and OS stimulation order 3
Intervention Description
OS, OS, PS
Primary Outcome Measure Information:
Title
Difference in broadband power with different settings
Description
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.
Time Frame
One year from baseline
Title
Difference in frequency band-specific low-frequency power (LFP) with different settings
Description
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.
Time Frame
One year from baseline
Secondary Outcome Measure Information:
Title
Identify all seizures
Description
Detecting generalized tonic-clonic seizures using a wearable sensor wristband and patients-reported seizure activity.
Time Frame
one year from baseline
Title
Scores on Montreal Cognitive Assessment, MoCA
Description
This is a brief cognitive assessment used to look at side effects of stimulation settings
Time Frame
one year from baseline
Title
Scores on epilepsy-specific quality of life questionnaire (QOLIE-10P)
Description
This is a brief cognitive assessment used to look at side effects of stimulation settings
Time Frame
One year from baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: medically refractory epilepsy already have a deep brain stimulator in place Exclusion Criteria: severe dementia at investigator discretion
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alec Jonason
Phone
612-624-3127
Email
jonas074@umn.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert McGovern, MD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alec Jonason
Phone
612-624-3127
Email
jonas074@umn.edu

12. IPD Sharing Statement

Learn more about this trial

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

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