Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2025-12-31 @ 3:10 PM
Study NCT ID:
NCT07060651
Status:
RECRUITING
Last Update Posted:
2025-07-11
First Post:
2022-12-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Characterization of Human Olfactory Amygdala Subregions Exp3
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-10', 'studyFirstSubmitDate': '2022-12-22', 'studyFirstSubmitQcDate': '2025-07-10', 'lastUpdatePostDateStruct': {'date': '2025-07-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Olfactory perception ratings using visual analog scale', 'timeFrame': '5 years', 'description': 'We will assess the change in olfactory ratings of odor stimuli due to electrical stimulation of the amygdala. The scale will be in arbutrary units based on the location of the cursor on the screen'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Human Olfactory Amygdala Function']}, 'descriptionModule': {'briefSummary': 'We aim to better understand the functions of the subregions of the human amygdala that receive direct projections from the olfactory bulb', 'detailedDescription': 'The human amygdala is part of primary olfactory cortex, in that it receives direct monosynaptic input from the olfactory bulb1-4. This suggests an important role for the amygdala in olfactory processing, yet the anatomical and functional properties of olfactory inputs to the human amygdala are largely unexplored. The overarching goal of this proposal is to elucidate the role of amygdala subregions in human olfactory processing.\n\nThe olfactory bulb projects in parallel to multiple cortical areas, each of which is thought to play a unique role in olfactory processing5-10. Within the amygdala, several distinct subregions receive direct, monosynaptic bulb input, suggesting distinct roles, yet their olfactory functions are not fully understood. Rodent studies have begun to explore potential roles for these subregions in olfactory-guided social and approach/avoid behaviors11- 15, with the first-ever recordings of the posterolateral cortical amygdala accomplished recently16. However, our understanding of these areas is still incomplete. Notably, most rodent studies on the olfactory amygdala subregions have focused on the accessory olfactory system, which humans lack. Furthermore, most human studies have not considered olfactory amygdala subregions separately17-21. This is a critical consideration, both because the majority of amygdala subregions do not receive olfactory inputs and because those that do likely play distinct roles in olfactory processing. These roles cannot be understood without analyzing the subregions separately. Thus, there is a strong need for more research into the role of the human amygdala subregions in olfaction. Importantly, olfactory amygdala subregions have been implicated in SUDEP22-26, the leading cause of death in temporal lobe epilepsy. Understanding the anatomical and functional properties of these regions is therefore of clinical importance as well.\n\nThis research will study human olfactory amygdala subregions using a multi-faceted, rigorous approach. It will combine specialized high-resolution diffusion-weighted imaging, high-resolution amygdala-targeted fMRI, rare direct electrical stimulation of the human amygdala (purely clinically prescribed) and human psychophysics, each suited to address a different question.\n\nThis experiment will assess the necessity of olfactory amygdala subregions in distinct olfactory behaviors. To assess the necessity of olfactory amygdala subregions in distinct olfactory behaviors , this experiment will use intracranial electrophysiology methods to record directly from, and deliver electrical stimulation directly into, human olfactory amygdala sub-regions during olfactory tasks. This method provides direct recordings of neural activity, and allows disruption of neural activity to test the necessity of specific regions for particular behaviors. This experiment will character effects of electrical stimulation on olfactory approach/avoid behaviors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* older than 18 years of age\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT07060651', 'briefTitle': 'Characterization of Human Olfactory Amygdala Subregions Exp3', 'organization': {'class': 'OTHER', 'fullName': 'Northwestern University'}, 'officialTitle': 'Characterization of Human Olfactory Amygdala Subregions Experiment 3', 'orgStudyIdInfo': {'id': 'STU00201349-3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'record and stimulate brain activity while smelling odors', 'description': 'Record and stimulate brain activity while smelling odors', 'interventionNames': ['Other: Present odors to participants while recording and stimulating brain activity']}], 'interventions': [{'name': 'Present odors to participants while recording and stimulating brain activity', 'type': 'OTHER', 'description': 'Present odors to participants while recording brain activity', 'armGroupLabels': ['record and stimulate brain activity while smelling odors']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Research Study Assistant', 'role': 'CONTACT', 'phone': '312-503-4437'}], 'facility': 'Northwestern human olfaction lab', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'centralContacts': [{'name': 'Christina Zelano, PhD', 'role': 'CONTACT', 'email': 'c-zelano@northwestern.edu', 'phone': '312-503-4437'}, {'name': 'Gregory Lane', 'role': 'CONTACT', 'email': 'lane@northwestern.edu', 'phone': '312-503-4437'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ANALYTIC_CODE'], 'timeFrame': 'Some of the above may be made available on our lab website, if relevant for the particular study. Data will be available with no time limitations. Data will be made available once published.', 'ipdSharing': 'YES', 'description': 'All data will be made freely available on our lab website and/or GitHub page. All raw data will be available'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwestern University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Christina Zelano', 'investigatorAffiliation': 'Northwestern University'}}}}