Ignite Creation Date:
2025-12-25 @ 1:03 AM
Ignite Modification Date:
2025-12-25 @ 11:16 PM
Study NCT ID:
NCT06083493
Status:
COMPLETED
Last Update Posted:
2024-11-19
First Post:
2023-10-03
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Neuromodulation of Conscious Perception: Investigating Thalamic Roles Through Ultrasonic Stimulation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'huangzu@med.umich.edu', 'phone': '734-615-2875', 'title': 'Zirui Huang', 'organization': 'University of Michigan'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 32 days', 'description': 'Adverse events were reviewed during the following 3 time points: at the time of the one-study visit, 24 hours via telephone after the study visit, and 30-days via medical chart review.', 'eventGroups': [{'id': 'EG000', 'title': 'LIFUP Excitation', 'description': 'The study will involve the enrollment of 60 participants, who will be randomly assigned to two groups, with each group consisting of 30 participants. The participants will be divided based on the type of transcranial LIFUP they will receive, either excitation or inhibition, targeting four specific thalamic areas.\n\nLIFUP excitation: The experimental will consist of a 10-minute baseline period (LIFUP-OFF) followed by four 10-minute sessions of stimulating (LIFUP-ON-excitation) four thalamic areas. The order of thalamic area stimulation will be counterbalanced across participants and will include the ventral anterior (VA), dorsal anterior (DA), ventral posterior (VP), and dorsal posterior (DP) sections of the thalamus.', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 4, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'LIFUP Inhibition', 'description': 'The study will involve the enrollment of 60 participants, who will be randomly assigned to two groups, with each group consisting of 30 participants. The participants will be divided based on the type of transcranial LIFUP they will receive, either excitation or inhibition, targeting four specific thalamic areas.\n\nLIFUP inhibition: The experimental will consist of a 10-minute baseline period (LIFUP-OFF) followed by four 10-minute sessions of stimulating (LIFUP-ON-inhibition) four thalamic areas. The order of thalamic area stimulation will be counterbalanced across participants and will include the ventral anterior (VA), dorsal anterior (DA), ventral posterior (VP), and dorsal posterior (DP) sections of the thalamus.', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 3, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Skin Irritation - Ear', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Eye Irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Muscle Spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Blurred Vision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Sensitivity Derived From the Signal Detection Theory (SDT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LIFUP Excitation', 'description': 'The study will involve the enrollment of 60 participants, who will be randomly assigned to two groups, with each group consisting of 30 participants. The participants will be divided based on the type of transcranial LIFUP they will receive, either excitation or inhibition, targeting four specific thalamic areas.\n\nLIFUP excitation: The experimental will consist of a 10-minute baseline period (LIFUP-OFF) followed by four 10-minute sessions of stimulating (LIFUP-ON-excitation) four thalamic areas. The order of thalamic area stimulation will be counterbalanced across participants and will include the ventral anterior (VA), dorsal anterior (DA), ventral posterior (VP), and dorsal posterior (DP) sections of the thalamus.'}, {'id': 'OG001', 'title': 'LIFUP Inhibition', 'description': 'The study will involve the enrollment of 60 participants, who will be randomly assigned to two groups, with each group consisting of 30 participants. The participants will be divided based on the type of transcranial LIFUP they will receive, either excitation or inhibition, targeting four specific thalamic areas.\n\nLIFUP inhibition: The experimental will consist of a 10-minute baseline period (LIFUP-OFF) followed by four 10-minute sessions of stimulating (LIFUP-ON-inhibition) four thalamic areas. The order of thalamic area stimulation will be counterbalanced across participants and will include the ventral anterior (VA), dorsal anterior (DA), ventral posterior (VP), and dorsal posterior (DP) sections of the thalamus.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0.7452', 'spread': '0.1128', 'groupId': 'OG000'}, {'value': '0.7419', 'spread': '0.1250', 'groupId': 'OG001'}]}]}, {'title': 'Following intervention', 'categories': [{'measurements': [{'value': '0.7520', 'spread': '0.1014', 'groupId': 'OG000'}, {'value': '0.7120', 'spread': '0.1674', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.02', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Up to 60 minutes after intervention', 'description': "SDT was a means of measuring participants' ability to differentiate between information-bearing patterns and random patterns that distract from the information. Sensitivity measured a participant's ability to differentiate between real and scrambled images on a scale from 0.0 to 1.0, with higher scores indicating better accuracy in detecting a signal when it was present and lower scores indicating more missed signals. A score of 1.0 was perfect sensitivity (i.e., never missing a real signal).", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Perceptual Criterion Derived From the Signal Detection Theory (SDT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LIFUP Excitation', 'description': 'The study will involve the enrollment of 60 participants, who will be randomly assigned to two groups, with each group consisting of 30 participants. The participants will be divided based on the type of transcranial LIFUP they will receive, either excitation or inhibition, targeting four specific thalamic areas.\n\nLIFUP excitation: The experimental will consist of a 10-minute baseline period (LIFUP-OFF) followed by four 10-minute sessions of stimulating (LIFUP-ON-excitation) four thalamic areas. The order of thalamic area stimulation will be counterbalanced across participants and will include the ventral anterior (VA), dorsal anterior (DA), ventral posterior (VP), and dorsal posterior (DP) sections of the thalamus.'}, {'id': 'OG001', 'title': 'LIFUP Inhibition', 'description': 'The study will involve the enrollment of 60 participants, who will be randomly assigned to two groups, with each group consisting of 30 participants. The participants will be divided based on the type of transcranial LIFUP they will receive, either excitation or inhibition, targeting four specific thalamic areas.\n\nLIFUP inhibition: The experimental will consist of a 10-minute baseline period (LIFUP-OFF) followed by four 10-minute sessions of stimulating (LIFUP-ON-inhibition) four thalamic areas. The order of thalamic area stimulation will be counterbalanced across participants and will include the ventral anterior (VA), dorsal anterior (DA), ventral posterior (VP), and dorsal posterior (DP) sections of the thalamus.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0.3008', 'spread': '0.2589', 'groupId': 'OG000'}, {'value': '0.2092', 'spread': '0.2940', 'groupId': 'OG001'}]}]}, {'title': 'Following intervention', 'categories': [{'measurements': [{'value': '0.3113', 'spread': '0.3000', 'groupId': 'OG000'}, {'value': '0.2770', 'spread': '0.3322', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.20', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Up to 60 minutes after intervention', 'description': 'SDT was a means of measuring participants\' ability to differentiate between information-bearing patterns and random patterns that distract from the information. Perceptual criterion measured a participant\'s tendency to say "yes" or "no" when the participant was unsure if a signal was present. Perceptual criterion was measured on a scale from -1.0 to 1.0, with a score of 0 indicating no bias towards "yes" or "no". Negative scores meant a bias towards "yes" (more likely to say a signal was present), while positive scores meant a bias towards "no" (more likely to say a signal was absent).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'LIFUP Excitation', 'description': 'The study will involve the enrollment of 60 participants, who will be randomly assigned to two groups, with each group consisting of 30 participants. The participants will be divided based on the type of transcranial LIFUP they will receive, either excitation or inhibition, targeting four specific thalamic areas.\n\nLIFUP excitation: The experimental will consist of a 10-minute baseline period (LIFUP-OFF) followed by four 10-minute sessions of stimulating (LIFUP-ON-excitation) four thalamic areas. The order of thalamic area stimulation will be counterbalanced across participants and will include the ventral anterior (VA), dorsal anterior (DA), ventral posterior (VP), and dorsal posterior (DP) sections of the thalamus.'}, {'id': 'FG001', 'title': 'LIFUP Inhibition', 'description': 'The study will involve the enrollment of 60 participants, who will be randomly assigned to two groups, with each group consisting of 30 participants. The participants will be divided based on the type of transcranial LIFUP they will receive, either excitation or inhibition, targeting four specific thalamic areas.\n\nLIFUP inhibition: The experimental will consist of a 10-minute baseline period (LIFUP-OFF) followed by four 10-minute sessions of stimulating (LIFUP-ON-inhibition) four thalamic areas. The order of thalamic area stimulation will be counterbalanced across participants and will include the ventral anterior (VA), dorsal anterior (DA), ventral posterior (VP), and dorsal posterior (DP) sections of the thalamus.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '27'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Technical issues with the interventional device', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Performed incorrect visual task', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Insufficient baseline performance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': '61 participants were consented for this trial. 1 participant was excluded before randomization because of a scheduling conflict.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'LIFUP Excitation', 'description': 'The study will involve the enrollment of 60 participants, who will be randomly assigned to two groups, with each group consisting of 30 participants. The participants will be divided based on the type of transcranial LIFUP they will receive, either excitation or inhibition, targeting four specific thalamic areas.\n\nLIFUP excitation: The experimental will consist of a 10-minute baseline period (LIFUP-OFF) followed by four 10-minute sessions of stimulating (LIFUP-ON-excitation) four thalamic areas. The order of thalamic area stimulation will be counterbalanced across participants and will include the ventral anterior (VA), dorsal anterior (DA), ventral posterior (VP), and dorsal posterior (DP) sections of the thalamus.'}, {'id': 'BG001', 'title': 'LIFUP Inhibition', 'description': 'The study will involve the enrollment of 60 participants, who will be randomly assigned to two groups, with each group consisting of 30 participants. The participants will be divided based on the type of transcranial LIFUP they will receive, either excitation or inhibition, targeting four specific thalamic areas.\n\nLIFUP inhibition: The experimental will consist of a 10-minute baseline period (LIFUP-OFF) followed by four 10-minute sessions of stimulating (LIFUP-ON-inhibition) four thalamic areas. The order of thalamic area stimulation will be counterbalanced across participants and will include the ventral anterior (VA), dorsal anterior (DA), ventral posterior (VP), and dorsal posterior (DP) sections of the thalamus.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '27.2', 'spread': '7.0', 'groupId': 'BG000'}, {'value': '24.5', 'spread': '5.3', 'groupId': 'BG001'}, {'value': '25.9', 'spread': '6.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Of the 61 participants consented, baseline data was not collected from 1 participant who was not randomized and did not participate in the trial.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-09-28', 'size': 1320865, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-10-21T14:08', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 61}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-11-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2024-06-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-24', 'studyFirstSubmitDate': '2023-10-03', 'resultsFirstSubmitDate': '2024-10-24', 'studyFirstSubmitQcDate': '2023-10-03', 'lastUpdatePostDateStruct': {'date': '2024-11-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-10-24', 'studyFirstPostDateStruct': {'date': '2023-10-16', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-11-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Sensitivity Derived From the Signal Detection Theory (SDT)', 'timeFrame': 'Up to 60 minutes after intervention', 'description': "SDT was a means of measuring participants' ability to differentiate between information-bearing patterns and random patterns that distract from the information. Sensitivity measured a participant's ability to differentiate between real and scrambled images on a scale from 0.0 to 1.0, with higher scores indicating better accuracy in detecting a signal when it was present and lower scores indicating more missed signals. A score of 1.0 was perfect sensitivity (i.e., never missing a real signal)."}, {'measure': 'Change in Perceptual Criterion Derived From the Signal Detection Theory (SDT)', 'timeFrame': 'Up to 60 minutes after intervention', 'description': 'SDT was a means of measuring participants\' ability to differentiate between information-bearing patterns and random patterns that distract from the information. Perceptual criterion measured a participant\'s tendency to say "yes" or "no" when the participant was unsure if a signal was present. Perceptual criterion was measured on a scale from -1.0 to 1.0, with a score of 0 indicating no bias towards "yes" or "no". Negative scores meant a bias towards "yes" (more likely to say a signal was present), while positive scores meant a bias towards "no" (more likely to say a signal was absent).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Perception'], 'conditions': ['Thalamus']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the role that the thalamus (the egg-shaped structure in the middle of your brain) plays in perception using a low-intensity ultrasound pulsation (LIFUP) device. The researchers expect to observe differential changes in the perceptual outcomes based on the LIFUP stimulation of different thalamic areas'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must be right-handed.\n* Must have normal or corrected-to-normal vision (while wearing contact lenses). Please note: persons who need eyeglasses to achieve 20/20 vision cannot be included in this study as eyeglasses cannot be worn during the study visit.\n* Must not be on any medications for any neurological, psychological, or psychiatric conditions.\n* Must be English speaking.\n* Must be capable of giving written informed consent.\n\nExclusion Criteria:\n\n• Vision that is not 20/20, or vision that is not corrected to 20/20 while wearing contact lenses.\n\nPlease note: persons needing eyeglasses to achieve 20/20 vision cannot be included in this study as eyeglasses cannot be worn during the study visit.\n\n* History of significant head injury with loss of consciousness.\n* Learning disability or other developmental disorder.\n* Medication use for any neurological, psychological, or psychiatric conditions.\n* Any impairment (sensory or motor loss), activity, or situation that in the judgment of the study coordinator or Principal Investigators would prevent satisfactory completion of the study protocol.'}, 'identificationModule': {'nctId': 'NCT06083493', 'briefTitle': 'Neuromodulation of Conscious Perception: Investigating Thalamic Roles Through Ultrasonic Stimulation', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'Neuromodulation of Conscious Perception: Investigating Thalamic Roles Through Ultrasonic Stimulation', 'orgStudyIdInfo': {'id': 'HUM00240514'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LIFUP excitation', 'description': 'The study will involve the enrollment of 60 participants, who will be randomly assigned to two groups, with each group consisting of 30 participants. The participants will be divided based on the type of transcranial LIFUP they will receive, either excitation or inhibition, targeting four specific thalamic areas.', 'interventionNames': ['Device: LIFUP excitation']}, {'type': 'EXPERIMENTAL', 'label': 'LIFUP inhibition', 'description': 'The study will involve the enrollment of 60 participants, who will be randomly assigned to two groups, with each group consisting of 30 participants. The participants will be divided based on the type of transcranial LIFUP they will receive, either excitation or inhibition, targeting four specific thalamic areas.', 'interventionNames': ['Device: LIFUP inhibition']}], 'interventions': [{'name': 'LIFUP excitation', 'type': 'DEVICE', 'description': 'The experimental will consist of a 10-minute baseline period (LIFUP-OFF) followed by four 10-minute sessions of stimulating (LIFUP-ON-excitation) four thalamic areas. The order of thalamic area stimulation will be counterbalanced across participants and will include the ventral anterior (VA), dorsal anterior (DA), ventral posterior (VP), and dorsal posterior (DP) sections of the thalamus.', 'armGroupLabels': ['LIFUP excitation']}, {'name': 'LIFUP inhibition', 'type': 'DEVICE', 'description': 'The experimental will consist of a 10-minute baseline period (LIFUP-OFF) followed by four 10-minute sessions of stimulating (LIFUP-ON-inhibition) four thalamic areas. The order of thalamic area stimulation will be counterbalanced across participants and will include the ventral anterior (VA), dorsal anterior (DA), ventral posterior (VP), and dorsal posterior (DP) sections of the thalamus.', 'armGroupLabels': ['LIFUP inhibition']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}], 'overallOfficials': [{'name': 'Zirui Huang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan'}, {'name': 'Anthony Hudetz', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Assistant Professor, Anesthesiology and Research Fellow, Anesthesiology', 'investigatorFullName': 'Zirui Huang', 'investigatorAffiliation': 'University of Michigan'}}}}