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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

Tracking Information
First Submitted Date  ICMJE May 20, 2019
First Posted Date  ICMJE May 22, 2019
Last Update Posted Date June 5, 2019
Actual Study Start Date  ICMJE April 24, 2019
Estimated Primary Completion Date January 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 23, 2019)
  • 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).
  • 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).
  • 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.
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: May 20, 2019)
  • 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. We will be analyzing stimulus-induced electrophysiological recordings, focusing on Event-Related Potentials (ERPs).
  • 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. We will be analyzing stimulus-induced electrophysiological recordings, focusing on Event-Related Spectral Potentials (ERSP).
  • 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.
  • 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
Change History Complete list of historical versions of study NCT03958903 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 20, 2019)
  • Electrophysiological changes in EMG [ Time Frame: 2 days ]
    Analyze changes in amplitude of electromyography (EMG) from resting state to EMG recordings across all tasks.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Investigations of Amygdala Function Using Neurophysiological Recording and Stimulation
Official Title  ICMJE Investigations of Amygdala Function Using Neurophysiological Recording and Stimulation
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE
  • Fear
  • PTSD
  • Panic Disorder
Intervention  ICMJE
  • 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.
Study Arms  ICMJE Experimental: Neurophysiological recording and stimulation of amygdala
Recording and stimulation of amygdala using Neuropace RNS devices at certain points through out the behavioral tasks.
Interventions:
  • Device: Amygdala recording and stimulation using Neuropace RNS
  • Behavioral: Behavioral tasks
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: June 3, 2019)
30
Original Estimated Enrollment  ICMJE
 (submitted: May 20, 2019)
10
Estimated Study Completion Date  ICMJE January 1, 2021
Estimated Primary Completion Date January 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03958903
Other Study ID Numbers  ICMJE 42227
DP1MH116506 ( U.S. NIH Grant/Contract )
FY18 small grant fund award ( Other Identifier: Department of Psychiatry, Stanford University )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Mahendra Bhati, Stanford University
Study Sponsor  ICMJE Stanford University
Collaborators  ICMJE National Institute of Mental Health (NIMH)
Investigators  ICMJE
Principal Investigator: Mahendra Bhati, MD Stanford University
PRS Account Stanford University
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP