Investigations of Amygdala Function Using Neurophysiological Recording and Stimulation

Study Overview
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Brief Summary
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This study aims to specifically examine the in vivo electrophysiology and effects of direct stimulation of the human amygdala during conditioned and evoked fear. Investigators will also examine amygdala electrophysiology and the effects of stimulation during tasks to examine the effects of reward on fear memory. This study will recruit subjects with a history of temporal lobe epilepsy (TLE) who have undergone neurosurgical implantation with FDA-approved, NeuroPace RNS devices for treatment of seizures. These patients provide a unique cohort with (Responsive Neurostimulation) RNS devices capable of both recording and stimulating the amygdala during performance of fear-based, behavioral tasks.

Official Title
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Investigations of Amygdala Function Using Neurophysiological Recording and Stimulation

Conditions
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Fear, PTSD, Panic Disorder

Intervention / Treatment
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* Device: Amygdala recording and stimulation using Neuropace RNS
* Behavioral: Behavioral tasks


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: be between age 18-65 years of age participants must have received the Neuropace RNS implant to treat their seizures have comprehension of instructions in the English language be on a stable dose of medications for their epilepsy have received the RNS System for Temporal Lobe Epilepsy have capacity to provide informed consent Exclusion Criteria: significant cognitive impairment (Mini Mental Status Examination score of less than 20) DSM-V diagnosis of alcohol/substance abuse (except nicotine) within the last month or a diagnosis of alcohol/substance dependence (except nicotine) within the last 6 months Unable to apply EEG cap History of traumatic brain injury Active or high suicide risk Unable to come to study site/lack of stable housing is pregnant or nursing Patient's treating neurologist determines that the patient's epilepsy is not stable enough to participate in this study Any condition (including psychiatric) which in the judgment of the Investigator would prevent the subject from completion of the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Neurophysiological recording and stimulation of amygdala<br>Recording and stimulation of amygdala using Neuropace RNS devices at certain points through out the behavioral tasks. | Device: Amygdala recording and stimulation using Neuropace RNS<br>* Subjects will undergo a series of different, fear-related, behavioral tasks while undergoing amygdala electrophysiology recording and stimulation using the Neuropace RNS devices.<br>Behavioral: Behavioral tasks<br>* Subjects perform a set of fear related behavioral tasks over 2 days, with 3 tasks each day.In addition to amygdala RNS recording and stimulation, recording of electroencephalography (EEG), electromyography (EMG), and electrodermal activity (EDA) will be performed using standard techniques to capture and quantify the fear response across all tasks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EEG(electroencephalography) amplitude changes | Analyze change in amplitude in microvolts -in resting state EEG recording and EEG recording across all the tasks as determined clinically by the Investigator. Investigators will be analyzing stimulus-induced electrophysiological recordings, focusing on Event-Related Potentials (ERPs). | 2 days | 
| EEG(electroencephalography) frequency changes | Analyze changes in frequency in Hertz- in resting state EEG recording and EEG recording across all the tasks as determined clinically by the Investigator. Investigators will be analyzing stimulus-induced electrophysiological recordings, focusing on Event-Related Spectral Potentials (ERSP). | 2 days | 
| ECoG (ElectroCorticoGraphy) amplitude changes | Quantify changes in ECoG measures as determined clinically by the Investigator.- using intracranial recordings from the Neuropace devices. Analyze changes in ECoG amplitude- in resting state and ECoG throughout task and stimulation. | 2 days | 
| ECoG (ElectroCorticoGraphy) frequency changes | Quantify changes in ECoG measures as determined clinically by the Investigator using intracranial recordings from the Neuropace devices. Analyze changes in ECoG frequency - in resting state and ECoG throughout task and stimulation | 2 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Electrophysiological changes in EMG | Analyze changes in amplitude of electromyography (EMG) from resting state to EMG recordings across all tasks. | 2 days | 
| Electrophysiological changes in EDA | Analyze changes in amplitude of electrodermal activity (EDA) from resting state to EMG recordings across all tasks. | 2 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Responsive neurostimulation, Amygdala electrophysiology, Neuropace RNS, Temporal lobe epilepsy, closed-loop brain stimulation