Navigation and Free Recall in Chronically Implanted Humans

Study Overview
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Brief Summary
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This study is designed to identify brain activity associated with good memory in subjects with a chronically implanted RNS® device and to study the effects of therapeutic stimulation for epilepsy on memory. This will be accomplished through analysis of ECoG data collected during memory encoding for short and long-term free recall as well as during navigation tasks.

Official Title
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Memory, Epilepsy and Brain Stimulation: Oscillatory Patterns During Real-world Navigation and Free Recall in Chronically Implanted Humans

Conditions
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Epilepsy

Intervention / Treatment
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* Other: electrical stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: able to give informed consent 18 years of age or older Diagnosis of epilepsy Implanted RNS® device and receiving therapeutic stimulation for epilepsy. Capable of completing experimental tasks in the judgment of the Principal Investigator Exclusion Criteria: RNS® Neurostimulator implanted within 3 months of experimental tasks.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RNS® Neurostimulator<br>Subjects with pharmaceutically intractable seizures who have been implanted with a RNS® Neurostimulator. | Other: electrical stimulation<br>* Stimulation applied will be within parameters commonly used for the treatment of epilepsy during periods of encoding, recall, and memory maintenance .<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of words recalled with and without stimulation. | This study is designed to study the effects of therapeutic stimulation for epilepsy on memory. This outcome will be assessed by free recall language and memory tasks. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the power spectrum of ECoG data with an increase of recalled words. | This study is designed to identify brain activity associated with good memory in subjects with a chronically implanted RNS® device. This outcome will be assessed by free recall language and memory tasks. | 30 days | 
| Proportion of words recalled during times of interictal activity. | This study is designed to investigate the effects of IEDs on spatial, long-term, and short-term memory. This will be assessed by free recall language and memory tasks. | 30 days | 
| Proportion of navigation challenges recalled successfully with and without stimulation. | This outcome will be assessed by real-world and virtual navigation tasks. | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Memory, Responsive Neurostimulator System