Ignite Creation Date:
2025-12-24 @ 2:05 PM
Ignite Modification Date:
2026-01-01 @ 6:57 PM
Study NCT ID:
NCT06159595
Status:
RECRUITING
Last Update Posted:
2025-11-04
First Post:
2023-11-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Behavioral and Neuronal Correlates of Human Mood States
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003865', 'term': 'Depressive Disorder, Major'}, {'id': 'D004827', 'term': 'Epilepsy'}], 'ancestors': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2025-10-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-31', 'studyFirstSubmitDate': '2023-11-16', 'studyFirstSubmitQcDate': '2023-12-04', 'lastUpdatePostDateStruct': {'date': '2025-11-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-12-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quantitative Audio-Facial Change', 'timeFrame': '5 minutes', 'description': 'Quantitative percent change in each audio-facial feature before and after direct electrical stimulation at each site.'}, {'measure': 'Quantitative Mood Change', 'timeFrame': '5 minutes', 'description': 'Quantitative percent change in Immediate Mood Scaler (IMS) after direct electrical stimulation at each site compared to a baseline period before sham. The minimum score on the IMS is 7 and the maximum is 154, with lower scores reflecting more negative mood states.'}], 'secondaryOutcomes': [{'measure': 'Correlation between Audio-Facial and Mood Change', 'timeFrame': '5 minutes', 'description': 'Quantitative audio facial changes will be compared to quantitative changes in mood at each site by means of correlation and binary comparisons.'}, {'measure': 'Qualitative Mood Change', 'timeFrame': '5 minutes', 'description': 'Qualitative articulation of mood (participants freely articulate mood after direct electrical stimulation at each site) and speech transcripts will be analyzed for ratio of positive and negative valence words.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Major Depressive Disorder', 'Epilepsy']}, 'descriptionModule': {'briefSummary': 'Optimizing treatments in mental health requires an easy to obtain, continuous, and objective measure of internal mood. Unfortunately, current standard-of-care clinical scales are sparsely sampled, subject to recency bias, underutilized, and are not validated for acute mood monitoring. The recent shift to remote care also requires novel methods to measure internal mood. Recent advances in computer vision have allowed the accurate quantification of observable speech patterns and facial representations. The continuous and objective nature of these audio-facial behavioral outputs also enable the study of their neural correlates. Here, the investigators hypothesize that video-derived audio-facial behaviors have discrete neural representations in the limbic network and can provide a critical set of reliable longitudinal estimates of mood at low cost across home and clinic settings.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age range between 18 and 65\n* Major depressive disorder (MDD) in a current major depressive episode diagnosed with the Mini-International Neuropsychiatric Interview (MINI)\n* No medical or surgical contraindication to electrode implantation\n* Patient capable of understanding the scope of our project or signing informed consent independently.\n\nExclusion Criteria:\n\n* Diffuse epilepsy involving several lobes of the brain'}, 'identificationModule': {'nctId': 'NCT06159595', 'briefTitle': 'Behavioral and Neuronal Correlates of Human Mood States', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Behavioral and Neuronal Correlates of Human Mood States', 'orgStudyIdInfo': {'id': '11354-2'}, 'secondaryIdInfos': [{'id': '1R21MH134172', 'link': 'https://reporter.nih.gov/quickSearch/1R21MH134172', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Active Direct electrical stimulation (DES)', 'description': 'Intracranial electrodes will be used for the delivery of invasive brain stimulation.', 'interventionNames': ['Device: Intracranial electrodes']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham Direct electrical stimulation (DES)', 'description': 'Intracranial electrodes will be used for the delivery of invasive brain stimulation.', 'interventionNames': ['Device: Intracranial electrodes']}], 'interventions': [{'name': 'Intracranial electrodes', 'type': 'DEVICE', 'description': 'Surgically-implanted intracranial electrodes.', 'armGroupLabels': ['Active Direct electrical stimulation (DES)', 'Sham Direct electrical stimulation (DES)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Stanford', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jade Truong', 'role': 'CONTACT', 'email': 'kellerlab@stanford.edu'}], 'facility': 'Stanford University', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}], 'centralContacts': [{'name': 'Jade Truong', 'role': 'CONTACT', 'email': 'kellerlab@stanford.edu', 'phone': '(408) 840-3313'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, Associate Professor', 'investigatorFullName': 'Corey Keller', 'investigatorAffiliation': 'Stanford University'}}}}