Investigations of Amygdala Function Using Neurophysiological Recording and Stimulation
Study Details
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.
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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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.
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Outcome Measures
Primary Outcome Measures
- EEG(electroencephalography) amplitude changes [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 [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 [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 [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
- Electrophysiological changes in EMG [2 days]
Analyze changes in amplitude of electromyography (EMG) from resting state to EMG recordings across all tasks.
- Electrophysiological changes in EDA [2 days]
Analyze changes in amplitude of electrodermal activity (EDA) from resting state to EMG recordings across all tasks.
Eligibility Criteria
Criteria
Inclusion Criteria:
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be between age 18-65 years of age
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participants must have received the Neuropace RNS implant to treat their seizures
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have comprehension of instructions in the English language
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be on a stable dose of medications for their epilepsy
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have received the RNS System for Temporal Lobe Epilepsy
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have capacity to provide informed consent
Exclusion Criteria:
- significant cognitive impairment (Mini Mental Status Examination score of less than
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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
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Unable to apply EEG cap
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History of traumatic brain injury
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Active or high suicide risk
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Unable to come to study site/lack of stable housing
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is pregnant or nursing
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Patient's treating neurologist determines that the patient's epilepsy is not stable enough to participate in this study
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Any condition (including psychiatric) which in the judgment of the Investigator would prevent the subject from completion of the study
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Stanford University | Palo Alto | California | United States | 94304 |
Sponsors and Collaborators
- Stanford University
- National Institute of Mental Health (NIMH)
Investigators
- Principal Investigator: Mahendra Bhati, MD, Stanford University
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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. Review.
- 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.
- 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. Review.
- 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.
- 42227
- DP1MH116506
- FY18 small grant fund award