Investigations of Amygdala Function Using Neurophysiological Recording and Stimulation

Not Applicable

Completed

• Conditions: PTSD; Fear; Panic Disorder
• Interventions: Device: Amygdala recording and stimulation using Neuropace RNS; Behavioral: Behavioral tasks

• Registration Number: NCT03958903
• Lead Sponsor: Stanford University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-04-24
• Study First Submitted: 2019-05-20
• Study First Submitted QC: 2019-05-20
• Study First Posted: 2019-05-22
• Primary Completion: 2020-03-13
• Study Completion: 2020-03-13
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-22
• Last Update Posted: 2023-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Neurophysiological recording and stimulation of amygdala	Amygdala recording and stimulation using Neuropace RNS	Recording and stimulation of amygdala using Neuropace RNS devices at certain points through out the behavioral tasks.
Neurophysiological recording and stimulation of amygdala	Behavioral tasks	Recording and stimulation of amygdala using Neuropace RNS devices at certain points through out the behavioral tasks.

Primary Outcome Measures

Name	Time	Method
ECoG (ElectroCorticoGraphy) frequency changes	2 days	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
EEG(electroencephalography) frequency changes	2 days	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).
ECoG (ElectroCorticoGraphy) amplitude changes	2 days	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.
EEG(electroencephalography) amplitude changes	2 days	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).

Secondary Outcome Measures

Name	Time	Method
Electrophysiological changes in EMG	2 days	Analyze changes in amplitude of electromyography (EMG) from resting state to EMG recordings across all tasks.
Electrophysiological changes in EDA	2 days	Analyze changes in amplitude of electrodermal activity (EDA) from resting state to EMG recordings across all tasks.

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Palo Alto, California, United States