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Investigations of Amygdala Function Using Neurophysiological Recording and Stimulation

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ClinicalTrials.gov Identifier: NCT03958903
Recruitment Status : Enrolling by invitation
First Posted : May 22, 2019
Last Update Posted : June 5, 2019
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Mahendra Bhati, 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.


Condition or disease Intervention/treatment Phase
Fear PTSD Panic Disorder Device: Amygdala recording and stimulation using Neuropace RNS Behavioral: Behavioral tasks Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Investigations of Amygdala Function Using Neurophysiological Recording and Stimulation
Actual Study Start Date : April 24, 2019
Estimated Primary Completion Date : January 1, 2021
Estimated Study Completion Date : January 1, 2021

Arm Intervention/treatment
Experimental: Neurophysiological recording and stimulation of amygdala
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
Subjects will undergo a series of different, fear-related, behavioral tasks while undergoing amygdala electrophysiology recording and stimulation using the Neuropace RNS devices.

Behavioral: Behavioral tasks
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 Measures :
  1. EEG(electroencephalography) amplitude changes [ Time Frame: 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).


  2. EEG(electroencephalography) frequency changes [ Time Frame: 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).


  3. ECoG (ElectroCorticoGraphy) amplitude changes [ Time Frame: 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.


  4. ECoG (ElectroCorticoGraphy) frequency changes [ Time Frame: 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



Secondary Outcome Measures :
  1. Electrophysiological changes in EMG [ Time Frame: 2 days ]
    Analyze changes in amplitude of electromyography (EMG) from resting state to EMG recordings across all tasks.

  2. Electrophysiological changes in EDA [ Time Frame: 2 days ]
    Analyze changes in amplitude of electrodermal activity (EDA) from resting state to EMG recordings across all tasks.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03958903


Locations
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United States, California
Stanford University
Palo Alto, California, United States, 94304
Sponsors and Collaborators
Stanford University
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Mahendra Bhati, MD Stanford University

Publications:
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Responsible Party: Mahendra Bhati, Clinical Associate Professor, Stanford University
ClinicalTrials.gov Identifier: NCT03958903     History of Changes
Other Study ID Numbers: 42227
DP1MH116506 ( U.S. NIH Grant/Contract )
FY18 small grant fund award ( Other Identifier: Department of Psychiatry, Stanford University )
First Posted: May 22, 2019    Key Record Dates
Last Update Posted: June 5, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by Mahendra Bhati, Stanford University:
Responsive neurostimulation
Amygdala electrophysiology
Neuropace RNS
Temporal lobe epilepsy
closed-loop brain stimulation

Additional relevant MeSH terms:
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Panic Disorder
Anxiety Disorders
Mental Disorders