Investigations of Amygdala Function Using Neurophysiological Recording and Stimulation
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|ClinicalTrials.gov Identifier: NCT03958903|
Recruitment Status : Completed
First Posted : May 22, 2019
Last Update Posted : December 14, 2022
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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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||23 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|
|Actual Primary Completion Date :||October 1, 2022|
|Actual Study Completion Date :||October 1, 2022|
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.
- 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
- 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.
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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|
- 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
- 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
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
|United States, California|
|Palo Alto, California, United States, 94304|
|Principal Investigator:||Mahendra Bhati, MD||Stanford University|
Documents provided by Mahendra Bhati, Stanford University:
|Responsible Party:||Mahendra Bhati, Clinical Professor, Stanford University|
|Other Study ID Numbers:||
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:||December 14, 2022|
|Last Verified:||December 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||Yes|
Temporal lobe epilepsy
closed-loop brain stimulation