Ignite Creation Date:
2025-12-24 @ 10:14 PM
Ignite Modification Date:
2026-01-02 @ 2:21 PM
Study NCT ID:
NCT05120635
Status:
RECRUITING
Last Update Posted:
2025-12-16
First Post:
2021-10-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intracranial Neurophysiological Signatures of Fear and Anxiety in Humans
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}], 'ancestors': [{'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D046690', 'term': 'Deep Brain Stimulation'}], 'ancestors': [{'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-11', 'studyFirstSubmitDate': '2021-10-04', 'studyFirstSubmitQcDate': '2021-11-03', 'lastUpdatePostDateStruct': {'date': '2025-12-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-11-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Physiological change - eye-blinks', 'timeFrame': 'during the intervention/behavioral tasks with and without stimulation', 'description': 'Eye blinks will be measured using an eye tracking device and will be measure in blinks per second.'}, {'measure': 'Physiological change - heart rate variability', 'timeFrame': 'during the intervention/behavioral tasks with and without stimulation', 'description': 'heart rate variability will be measured in milliseconds.'}, {'measure': 'Physiological change - skin conductance', 'timeFrame': 'during the intervention/behavioral tasks with and without stimulation', 'description': 'Skin conductance will be measured in microSiemens.'}, {'measure': 'Neurophysiological activity', 'timeFrame': 'during the intervention/behavioral tasks with and without stimulation', 'description': 'Neurophysiological activity will be measured in Hz'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Fear', 'GAD', 'Emotional Memory', 'PTSD']}, 'descriptionModule': {'briefSummary': 'Anxiety disorders such as post-traumatic stress disorder (PTSD) and generalized anxiety disorder (GAD) affect a large number of individuals with a significant portion of patients failing to improve with current treatments.\n\nThe purpose of this study is to understand the brain mechanisms that produce fear and anxiety in humans. To accomplish this goal, we will measure the brain activity along with the heart rate and skin perspiration of patients while they are completing tasks on a computer. Some of the tasks will also use a virtual reality headset and transport the patient in a video game-like environment. These tasks will expose the participants to various levels of fear-provoking images. Participants with responsive neurostimulation (RNS) implants will be enrolled under Pro00117931 at Duke, but their results for fear and anxiety tasks will be reported under NCT05120635.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age or older\n* Has undergone acute depth or chronic responsive neurostimulation (RNS) electrode placement\n* Willing to provide informed consent and participate in the study\n* Ability to read and write English fluently\n\nExclusion Criteria:\n\n* Unwilling to provide informed consent\n* Has not undergone acute depth or chronic responsive neurostimulation (RNS) electrode placement\n* Pregnant women\n* Participants with active psychosis\n* Participants with suicidal ideation\n* Participants with substance abuse issues'}, 'identificationModule': {'nctId': 'NCT05120635', 'briefTitle': 'Intracranial Neurophysiological Signatures of Fear and Anxiety in Humans', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Intracranial Neurophysiological Signatures of Fear and Anxiety in Humans', 'orgStudyIdInfo': {'id': 'PRO00118015'}, 'secondaryIdInfos': [{'id': 'R01MH124761', 'link': 'https://reporter.nih.gov/quickSearch/R01MH124761', 'type': 'NIH'}, {'id': 'Pro00117931', 'type': 'OTHER', 'domain': 'Duke University'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'EMU Participants', 'description': 'Subjects participating in the study at the Epilepsy Monitoring Unity (EMU).', 'interventionNames': ['Device: Deep Brain Stimulation', 'Behavioral: Virtual and augmented reality tasks']}, {'type': 'OTHER', 'label': 'RNS Participants', 'description': 'Subjects with RNS implants.', 'interventionNames': ['Device: Deep Brain Stimulation', 'Behavioral: Virtual and augmented reality tasks']}], 'interventions': [{'name': 'Deep Brain Stimulation', 'type': 'DEVICE', 'description': 'Deep brain stimulation will be used', 'armGroupLabels': ['EMU Participants', 'RNS Participants']}, {'name': 'Virtual and augmented reality tasks', 'type': 'BEHAVIORAL', 'description': 'Virtual and augmented reality tasks will be used.', 'armGroupLabels': ['EMU Participants', 'RNS Participants']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90024', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sonja Hiller', 'role': 'CONTACT', 'email': 'suthanalab@mednet.ucla.edu', 'phone': '919-681-2577'}], 'facility': 'University of California Los Angeles', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '27705', 'city': 'Durham', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Gabriela Vilchez', 'role': 'CONTACT', 'email': 'suthanalab@duke.edu', 'phone': '919-681-2577'}, {'name': 'Nanthia Suthana, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Duke University Health System', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'centralContacts': [{'name': 'Gabriela Vilchez', 'role': 'CONTACT', 'email': 'suthanalab@duke.edu', 'phone': '9196812577'}], 'overallOfficials': [{'name': 'Nanthia Suthana, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}, {'name': 'VA Greater Los Angeles Healthcare System', 'class': 'FED'}, {'name': 'NeuroPace', 'class': 'INDUSTRY'}, {'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}