Ignite Creation Date:
2025-12-25 @ 3:19 AM
Ignite Modification Date:
2025-12-26 @ 1:57 AM
Study NCT ID:
NCT07242105
Status:
RECRUITING
Last Update Posted:
2025-11-21
First Post:
2025-11-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Optimizing Brain Excitability in Depression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003865', 'term': 'Depressive Disorder, Major'}], 'ancestors': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D050781', 'term': 'Transcranial Magnetic Stimulation'}], 'ancestors': [{'id': 'D055909', 'term': 'Magnetic Field Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 145}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-10-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2029-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-19', 'studyFirstSubmitDate': '2025-11-11', 'studyFirstSubmitQcDate': '2025-11-19', 'lastUpdatePostDateStruct': {'date': '2025-11-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2029-08-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in Anterior EL-TEP Amplitude after spTMS', 'timeFrame': 'Baseline, end of spTMS (6 hours)', 'description': 'Changes in Early Local TMS-Evoked Potentials (EL-TEP) following 6 hours of either active or sham spTMS between optimized and non-optimized stimulation conditions in the anterior dlPFC.'}, {'measure': 'Changes in Posterior EL-TEP Amplitude after spTMS', 'timeFrame': 'Baseline, end of spTMS (6 hours)', 'description': 'Changes in Early Local TMS-Evoked Potentials (EL-TEP) following 6 hours of either active or sham spTMS between optimized and non-optimized stimulation conditions in the posterior dlPFC.'}, {'measure': 'Changes in iTEP Amplitude after TMS-iEEG', 'timeFrame': 'Baseline, end of spTMS (20 minutes)', 'description': 'Changes in the interaction between gyral/sulcal targets and coil angles (45 vs 90 degrees) on local dlPFC iTEP amplitude.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['tms', 'eeg'], 'conditions': ['Major Depressive Disorder']}, 'descriptionModule': {'briefSummary': 'The goal of this study is to improve depression treatment by establishing reliable prefrontal excitability markers through Targeting with Automated Real-time Guidance for Enhancing TEPs (TARGET).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women, ages 18 to 65\n* Diagnosis of major depressive disorder, assessed through a Structured Clinical Interview for DSM-5 (SCID-5)\n* In a current depressive episode, assessed through a Structured Clinical Interview for DSM-5 (SCID-5)\n* Moderate-to-severe depression as indicated by a score between 11-20 on the Quick Inventory of Depressive Symptoms (QIDS)\n* Must comprehend English well to ensure adequate comprehension of the EEG and TMS instructions, and of clinical scales\n* No current or history of neurological disorders\n* No seizure disorder or risk of seizures\n* Neurosurgical patients: Men and women ages 18-65 with medication-refractory epilepsy who are admitted for phase II intracranial monitoring to detect a seizure focus will be considered appropriate for this study. Participants must have the intellectual capacity to understand the consent process and agree to the study.\n\nExclusion Criteria:\n\n* Those with a contraindication for MRIs (e.g. implanted metal)\n* History of head trauma with loss of consciousness\n* History of seizures or on medications that reduce seizure threshold (e.g., olanzapine, chlorpromazine, lithium)\n* Neurological or uncontrolled medical disease\n* Any unstable medical condition\n* Active substance abuse\n* Diagnosis of psychotic or bipolar disorder\n* A prior history of ECT failure\n* History of suicide attempt in the past year\n* Currently pregnant or breastfeeding\n* rTMS treatment in the past six months'}, 'identificationModule': {'nctId': 'NCT07242105', 'acronym': 'TARGET', 'briefTitle': 'Optimizing Brain Excitability in Depression', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Optimized Methods for Measuring Brain Excitability in Depression', 'orgStudyIdInfo': {'id': '72673-1'}, 'secondaryIdInfos': [{'id': '1R01MH139650', 'link': 'https://reporter.nih.gov/quickSearch/1R01MH139650', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active TMS, Sham TMS with iEEG', 'description': 'Neurosurgical participants receive both active single-pulse TMS and sham single-pulse TMS delivered to predefined dlPFC sites while undergoing intracranial EEG recording. The order of active and sham stimulation is randomized.', 'interventionNames': ['Device: Active Single-Pulse TMS', 'Device: Sham Single-Pulse TMS', 'Other: Intracranial EEG (iEEG) Recording']}, {'type': 'EXPERIMENTAL', 'label': 'Sham TMS, Active TMS with iEEG', 'description': 'Neurosurgical participants receive sham single-pulse TMS followed by active single-pulse TMS at predefined dlPFC sites during intracranial EEG recording. The order of stimulation conditions is randomized.', 'interventionNames': ['Device: Active Single-Pulse TMS', 'Device: Sham Single-Pulse TMS', 'Other: Intracranial EEG (iEEG) Recording']}, {'type': 'EXPERIMENTAL', 'label': 'Optimized TMS, Non-optimized TMS with EEG', 'description': 'Participants receive both TARGET optimized single-pulse TMS and non-optimized (open-loop) single-pulse TMS to the dlPFC while undergoing concurrent scalp EEG. The sequence of optimized and non-optimized stimulation is randomized.', 'interventionNames': ['Device: TARGET-optimized TMS', 'Device: Non-optimized (Open-Loop) TMS', 'Other: EEG Recording']}, {'type': 'EXPERIMENTAL', 'label': 'Non-optimized TMS, Optimized TMS with EEG', 'description': 'Participants receive non-optimized (open-loop) single-pulse TMS followed by TARGET optimized single-pulse TMS to the dlPFC with concurrent scalp EEG. The order of stimulation conditions is randomized.', 'interventionNames': ['Device: TARGET-optimized TMS', 'Device: Non-optimized (Open-Loop) TMS', 'Other: EEG Recording']}], 'interventions': [{'name': 'Active Single-Pulse TMS', 'type': 'DEVICE', 'description': 'Single-pulse transcranial magnetic stimulation is delivered to the left dorsolateral prefrontal cortex using a MagVenture X100 stimulator and B65 A/P coil across predefined locations, coil angles, and stimulation intensities.', 'armGroupLabels': ['Active TMS, Sham TMS with iEEG', 'Sham TMS, Active TMS with iEEG']}, {'name': 'Sham Single-Pulse TMS', 'type': 'DEVICE', 'description': 'Sham single-pulse TMS is delivered using a flipped coil and concurrent scalp electrical stimulation to mimic auditory and somatosensory sensations without producing cortical stimulation.', 'armGroupLabels': ['Active TMS, Sham TMS with iEEG', 'Sham TMS, Active TMS with iEEG']}, {'name': 'TARGET-optimized TMS', 'type': 'DEVICE', 'description': 'Single-pulse TMS parameters (location, angle, and intensity) are adjusted in real time using the TARGET closed-loop algorithm based on concurrent EEG measurements to deliver optimized stimulation.', 'armGroupLabels': ['Non-optimized TMS, Optimized TMS with EEG', 'Optimized TMS, Non-optimized TMS with EEG']}, {'name': 'Non-optimized (Open-Loop) TMS', 'type': 'DEVICE', 'description': 'Single-pulse TMS is delivered using a predefined open-loop set of stimulation parameter combinations across multiple dlPFC locations, coil angles, and intensities without real-time adjustment.', 'armGroupLabels': ['Non-optimized TMS, Optimized TMS with EEG', 'Optimized TMS, Non-optimized TMS with EEG']}, {'name': 'EEG Recording', 'type': 'OTHER', 'description': 'Participants undergo concurrent 64-channel TMS-compatible scalp EEG recording during stimulation to measure TMS-evoked neural responses.', 'armGroupLabels': ['Non-optimized TMS, Optimized TMS with EEG', 'Optimized TMS, Non-optimized TMS with EEG']}, {'name': 'Intracranial EEG (iEEG) Recording', 'type': 'OTHER', 'description': 'Neurosurgical participants undergo intracranial EEG recording using clinically implanted electrodes during TMS to measure local and downstream neural activity.', 'armGroupLabels': ['Active TMS, Sham TMS with iEEG', 'Sham TMS, Active TMS with iEEG']}]}, 'contactsLocationsModule': {'locations': [{'zip': '52246', 'city': 'Iowa City', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jade T Truong, BS', 'role': 'CONTACT', 'email': 'kellerlab@stanford.edu', 'phone': '408-840-3313'}, {'name': 'Aaron D Boes, MD, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University of Iowa', 'geoPoint': {'lat': 39.29156, 'lon': -121.47747}}, {'zip': '94305', 'city': 'Stanford', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jade T Truong, BS', 'role': 'CONTACT', 'email': 'kellerlab@stanford.edu', 'phone': '408-840-3313'}, {'name': 'Corey J Keller, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Stanford University', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}], 'centralContacts': [{'name': 'Jade T Truong, BS', 'role': 'CONTACT', 'email': 'kellerlab@stanford.edu', 'phone': '408-840-3313'}], 'overallOfficials': [{'name': 'Corey J Keller, MD, PhD', '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': 'Associate Professor', 'investigatorFullName': 'Corey Keller', 'investigatorAffiliation': 'Stanford University'}}}}