Investigations of Amygdala Function Using Neurophysiological Recording and Stimulation

Stanford University

Status: Completed

Conditions: Fear; Panic Disorder; PTSD

Treatments: Behavioral: Behavioral tasks; Device: Amygdala recording and stimulation using Neuropace RNS

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03958903

DP1MH116506 (U.S. NIH Grant/Contract)

42227

FY18 small grant fund award (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 23 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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23 participants in 1 patient group

Neurophysiological recording and stimulation of amygdala

Experimental group

Description:

Recording and stimulation of amygdala using Neuropace RNS devices at certain points through out the behavioral tasks.

Treatment:

Behavioral: Behavioral tasks

Device: Amygdala recording and stimulation using Neuropace RNS