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Investigations of Amygdala Function Using Neurophysiological Recording and Stimulation

Primary Purpose

Fear, PTSD, Panic Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Amygdala recording and stimulation using Neuropace RNS
Behavioral tasks
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Fear focused on measuring Responsive neurostimulation, Amygdala electrophysiology, Neuropace RNS, Temporal lobe epilepsy, closed-loop brain stimulation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Stanford University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Neurophysiological recording and stimulation of amygdala

Arm Description

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

Outcomes

Primary Outcome Measures

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).
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).
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.
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

Secondary Outcome Measures

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

Full Information

First Posted
May 20, 2019
Last Updated
September 22, 2023
Sponsor
Stanford University
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT03958903
Brief Title
Investigations of Amygdala Function Using Neurophysiological Recording and Stimulation
Official Title
Investigations of Amygdala Function Using Neurophysiological Recording and Stimulation
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
April 24, 2019 (Actual)
Primary Completion Date
March 13, 2020 (Actual)
Study Completion Date
March 13, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fear, PTSD, Panic Disorder
Keywords
Responsive neurostimulation, Amygdala electrophysiology, Neuropace RNS, Temporal lobe epilepsy, closed-loop brain stimulation

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Neurophysiological recording and stimulation of amygdala
Arm Type
Experimental
Arm Description
Recording and stimulation of amygdala using Neuropace RNS devices at certain points through out the behavioral tasks.
Intervention Type
Device
Intervention Name(s)
Amygdala recording and stimulation using Neuropace RNS
Intervention Description
Subjects will undergo a series of different, fear-related, behavioral tasks while undergoing amygdala electrophysiology recording and stimulation using the Neuropace RNS devices.
Intervention Type
Behavioral
Intervention Name(s)
Behavioral tasks
Intervention Description
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.
Primary Outcome Measure Information:
Title
EEG(electroencephalography) amplitude changes
Description
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).
Time Frame
2 days
Title
EEG(electroencephalography) frequency changes
Description
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).
Time Frame
2 days
Title
ECoG (ElectroCorticoGraphy) amplitude changes
Description
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.
Time Frame
2 days
Title
ECoG (ElectroCorticoGraphy) frequency changes
Description
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
Time Frame
2 days
Secondary Outcome Measure Information:
Title
Electrophysiological changes in EMG
Description
Analyze changes in amplitude of electromyography (EMG) from resting state to EMG recordings across all tasks.
Time Frame
2 days
Title
Electrophysiological changes in EDA
Description
Analyze changes in amplitude of electrodermal activity (EDA) from resting state to EMG recordings across all tasks.
Time Frame
2 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mahendra Bhati, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22850830
Citation
Gross CT, Canteras NS. The many paths to fear. Nat Rev Neurosci. 2012 Sep;13(9):651-8. doi: 10.1038/nrn3301. Epub 2012 Aug 1.
Results Reference
background
PubMed Identifier
17898336
Citation
Etkin A, Wager TD. Functional neuroimaging of anxiety: a meta-analysis of emotional processing in PTSD, social anxiety disorder, and specific phobia. Am J Psychiatry. 2007 Oct;164(10):1476-88. doi: 10.1176/appi.ajp.2007.07030504.
Results Reference
background
PubMed Identifier
26615113
Citation
Morrell MJ, Halpern C. Responsive Direct Brain Stimulation for Epilepsy. Neurosurg Clin N Am. 2016 Jan;27(1):111-21. doi: 10.1016/j.nec.2015.08.012.
Results Reference
background
PubMed Identifier
21182851
Citation
Sato W, Kochiyama T, Uono S, Matsuda K, Usui K, Inoue Y, Toichi M. Rapid amygdala gamma oscillations in response to fearful facial expressions. Neuropsychologia. 2011 Mar;49(4):612-7. doi: 10.1016/j.neuropsychologia.2010.12.025. Epub 2010 Dec 21.
Results Reference
background
PubMed Identifier
26475671
Citation
Langevin JP, Koek RJ, Schwartz HN, Chen JWY, Sultzer DL, Mandelkern MA, Kulick AD, Krahl SE. Deep Brain Stimulation of the Basolateral Amygdala for Treatment-Refractory Posttraumatic Stress Disorder. Biol Psychiatry. 2016 May 15;79(10):e82-e84. doi: 10.1016/j.biopsych.2015.09.003. Epub 2015 Sep 11. No abstract available.
Results Reference
background
PubMed Identifier
25775597
Citation
Clarke HF, Horst NK, Roberts AC. Regional inactivations of primate ventral prefrontal cortex reveal two distinct mechanisms underlying negative bias in decision making. Proc Natl Acad Sci U S A. 2015 Mar 31;112(13):4176-81. doi: 10.1073/pnas.1422440112. Epub 2015 Mar 16.
Results Reference
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Investigations of Amygdala Function Using Neurophysiological Recording and Stimulation

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