Ignite Creation Date:
2025-12-24 @ 7:35 PM
Ignite Modification Date:
2025-12-28 @ 12:34 PM
Study NCT ID:
NCT03958903
Status:
COMPLETED
Last Update Posted:
2023-09-26
First Post:
2019-05-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigations of Amygdala Function Using Neurophysiological Recording and Stimulation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}, {'id': 'D016584', 'term': 'Panic Disorder'}, {'id': 'D004833', 'term': 'Epilepsy, Temporal Lobe'}], 'ancestors': [{'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D004828', 'term': 'Epilepsies, Partial'}, {'id': 'D004827', 'term': 'Epilepsy'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D000073376', 'term': 'Epileptic Syndromes'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-11-30', 'size': 388485, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2022-12-09T19:01', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2020-03-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-22', 'studyFirstSubmitDate': '2019-05-20', 'studyFirstSubmitQcDate': '2019-05-20', 'lastUpdatePostDateStruct': {'date': '2023-09-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'EEG(electroencephalography) amplitude changes', 'timeFrame': '2 days', 'description': 'Analyze change in amplitude in microvolts -in resting state EEG recording and EEG recording across all the tasks as determined clinically by the Investigator.\n\nInvestigators will be analyzing stimulus-induced electrophysiological recordings, focusing on Event-Related Potentials (ERPs).'}, {'measure': 'EEG(electroencephalography) frequency changes', 'timeFrame': '2 days', 'description': 'Analyze changes in frequency in Hertz- in resting state EEG recording and EEG recording across all the tasks as determined clinically by the Investigator.\n\nInvestigators will be analyzing stimulus-induced electrophysiological recordings, focusing on Event-Related Spectral Potentials (ERSP).'}, {'measure': 'ECoG (ElectroCorticoGraphy) amplitude changes', 'timeFrame': '2 days', 'description': 'Quantify changes in ECoG measures as determined clinically by the Investigator.- using intracranial recordings from the Neuropace devices.\n\nAnalyze changes in ECoG amplitude- in resting state and ECoG throughout task and stimulation.'}, {'measure': 'ECoG (ElectroCorticoGraphy) frequency changes', 'timeFrame': '2 days', 'description': 'Quantify changes in ECoG measures as determined clinically by the Investigator using intracranial recordings from the Neuropace devices.\n\nAnalyze changes in ECoG frequency - in resting state and ECoG throughout task and stimulation'}], 'secondaryOutcomes': [{'measure': 'Electrophysiological changes in EMG', 'timeFrame': '2 days', 'description': 'Analyze changes in amplitude of electromyography (EMG) from resting state to EMG recordings across all tasks.'}, {'measure': 'Electrophysiological changes in EDA', 'timeFrame': '2 days', 'description': 'Analyze changes in amplitude of electrodermal activity (EDA) from resting state to EMG recordings across all tasks.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Responsive neurostimulation', 'Amygdala electrophysiology', 'Neuropace RNS', 'Temporal lobe epilepsy', 'closed-loop brain stimulation'], 'conditions': ['Fear', 'PTSD', 'Panic Disorder']}, 'referencesModule': {'references': [{'pmid': '22850830', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '17898336', 'type': 'BACKGROUND', 'citation': '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. doi: 10.1176/appi.ajp.2007.07030504.'}, {'pmid': '26615113', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '21182851', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '26475671', 'type': 'BACKGROUND', 'citation': '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. No abstract available.'}, {'pmid': '25775597', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThis 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* be between age 18-65 years of age\n* participants must have received the Neuropace RNS implant to treat their seizures\n* have comprehension of instructions in the English language\n* be on a stable dose of medications for their epilepsy\n* have received the RNS System for Temporal Lobe Epilepsy\n* have capacity to provide informed consent\n\nExclusion Criteria:\n\n* significant cognitive impairment (Mini Mental Status Examination score of less than 20)\n* 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\n* Unable to apply EEG cap\n* History of traumatic brain injury\n* Active or high suicide risk\n* Unable to come to study site/lack of stable housing\n* is pregnant or nursing\n* Patient's treating neurologist determines that the patient's epilepsy is not stable enough to participate in this study\n* Any condition (including psychiatric) which in the judgment of the Investigator would prevent the subject from completion of the study"}, 'identificationModule': {'nctId': 'NCT03958903', 'briefTitle': 'Investigations of Amygdala Function Using Neurophysiological Recording and Stimulation', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Investigations of Amygdala Function Using Neurophysiological Recording and Stimulation', 'orgStudyIdInfo': {'id': '42227'}, 'secondaryIdInfos': [{'id': 'DP1MH116506', 'link': 'https://reporter.nih.gov/quickSearch/DP1MH116506', 'type': 'NIH'}, {'id': 'FY18 small grant fund award', 'type': 'OTHER', 'domain': 'Department of Psychiatry, Stanford University'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Neurophysiological recording and stimulation of amygdala', 'description': 'Recording and stimulation of amygdala using Neuropace RNS devices at certain points through out the behavioral tasks.', 'interventionNames': ['Device: Amygdala recording and stimulation using Neuropace RNS', 'Behavioral: Behavioral tasks']}], 'interventions': [{'name': 'Amygdala recording and stimulation using Neuropace RNS', 'type': 'DEVICE', 'description': 'Subjects will undergo a series of different, fear-related, behavioral tasks while undergoing amygdala electrophysiology recording and stimulation using the Neuropace RNS devices.', 'armGroupLabels': ['Neurophysiological recording and stimulation of amygdala']}, {'name': 'Behavioral tasks', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Neurophysiological recording and stimulation of amygdala']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}], 'overallOfficials': [{'name': 'Mahendra Bhati, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Mahendra Bhati', 'investigatorAffiliation': 'Stanford University'}}}}