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

Early Phase 1

Recruiting

• Conditions: Refractory Epilepsy; Deep Brain Stimulation
• Interventions: Other: PS and OS stimulation order 1; Other: PS and OS stimulation order 2; Other: PS and OS stimulation order 3

• Registration Number: NCT05493722
• Lead Sponsor: University of Minnesota

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-05
• Study First Submitted QC: 2022-08-05
• Study First Posted: 2022-08-09
• Study Start: 2023-09-15
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-06
• Last Update Posted: 2024-10-08
• Primary Completion: 2028-01-15
• Study Completion: 2030-01-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

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

Exclusion Criteria

• severe dementia at investigator discretion

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Stimulation Group A	PS and OS stimulation order 1	Participants with already implanted DBS will receive stimulation order 1. PS, OS, OS.
Stimulation Group B	PS and OS stimulation order 2	Participants with already implanted DBS will receive stimulation order 1. OS, PS, OS.
Stimulation Group C	PS and OS stimulation order 3	Participants with already implanted DBS will receive stimulation order 1. OS, OS, PS.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Identify all seizures	one year from baseline	Detecting generalized tonic-clonic seizures using a wearable sensor wristband and patients-reported seizure activity.
Scores on Montreal Cognitive Assessment, MoCA	one year from baseline	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)	One year from baseline	This is a brief cognitive assessment used to look at side effects of stimulation settings

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States