Network Effects of Therapeutic Deep Brain Stimulation

Study Overview
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Brief Summary
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The purpose of this study is to map the acute, short-term cortical evoked responses to thalamic electrical stimulation in persons with intractable epilepsy

Official Title
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Network Effects of Therapeutic Deep Brain Stimulation

Conditions
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Intractable Epilepsy

Intervention / Treatment
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* Device: RNS/DBS activation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnosis of Epilepsy undergoing neuromodulation therapy with clinically implanted neuromodulation devices (DBS, RNS) followed in the outpatient epilepsy clinic Exclusion Criteria: pregnant women active psychosis, major depression, or suicidal ideation in the preceding year Intelligence quotient (IQ) less than 70 as measured by clinical neuropsychological evaluation Do not agree to share their medical records for research purposes

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: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br> | Device: RNS/DBS activation<br>* This will be performed to study the EEG responses to DBS/RNS stimulation electrical pulses. The stimulation frequencies will be sequentially increased and each stimulation will last for 2 minutes.There will be a 1-2 minute wash out period after each trial.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in amplitude of evoked potentials metrics as assessed by the scalp EEG |  | Baseline, Intra intervention (about 20 minutes after baseline) | 
| Change in amplitude of evoked potentials metrics as assessed by the scalp EEG |  | Baseline, post intervention (about 2 hours after baseline ) | 
| Change in latencies of evoked potentials and phase synchronization metrics recorded as assessed by the scalp EEG |  | Baseline, Intra intervention (about 20 minutes after baseline) | 
| Change in latencies of evoked potentials and phase synchronization metrics recorded as assessed by the scalp EEG |  | Baseline, post intervention (about 2 hours after baseline ) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in reaction time to visual stimuli measured as vigilance score assessed by the Psychomotor Vigilance test (PVT) | This is a computerized testing that will record errors in being unable to tap a switch/button | Baseline, Intra intervention (about 20 minutes after baseline) | 
| Change in reaction time to visual stimuli measured as vigilance score assessed by the Psychomotor Vigilance test (PVT) | This is a computerized testing that will record errors in being unable to tap a switch/button | Baseline, post intervention (about 2 hours after baseline) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Deep brain stimulation (DBS), neuromodulation therapy, Responsive Neurostimulation (RNS)