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Completed

NCT Number: NCT03958903

Investigations of Amygdala Function Using Neurophysiological Recording and Stimulation

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.

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Key information

Conditions

Fear Anxiety Disorders Brain Diseases Central Nervous System Diseases Epilepsies, Partial Epilepsy Epilepsy, Temporal Lobe Epileptic Syndromes Mental Disorders Nervous System Diseases PTSD Panic Disorder Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University

Palo Alto, California, 94304, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Amygdala recording and stimulation using Neuropace RNS

Device

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

behavioral tasks

Behavioral

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 22, 2019
Registry last updated
Sep 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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