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

Study Overview
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Brief Summary
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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.

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

Conditions
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Refractory Epilepsy, Deep Brain Stimulation

Intervention / Treatment
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* Other: PS and OS stimulation order 1
* Other: PS and OS stimulation order 2
* Other: PS and OS stimulation order 3


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: medically refractory epilepsy already have a deep brain stimulator in place Exclusion Criteria: severe dementia at investigator discretion

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | One year from baseline | 
| 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. | One year from baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identify all seizures | 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 | 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) | This is a brief cognitive assessment used to look at side effects of stimulation settings | One year from baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Refractory Epilepsy, deep brain stimulation