CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 23 enrolled
Drug / intervention
Amygdala recording and stimulation using Neuropace RNS +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03958903
NCT03958903N/ACompleted

Investigations of Amygdala Function Using Neurophysiological Recording and Stimulation

Stanford University·interventional·Posted May 22, 2019·Updated Sep 26, 2023

In Brief

A clinical study evaluating Amygdala recording and stimulation using Neuropace RNS and Behavioral tasks for Fear and 2 related conditions. Completed, enrolled 23 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedMay 22, 2019
Enrollment StartApr 24, 2019
Primary CompletionMar 13, 2020
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 7.1 years ago

Interventions

Amygdala recording and stimulation using Neuropace RNSdevice

Subjects will undergo a series of different, fear-related, behavioral tasks while undergoing amygdala electrophysiology recording and stimulation using the Neuropace RNS devices.

Behavioral tasksbehavioral

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.