Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2025-12-25 @ 9:24 PM
Study NCT ID:
NCT05298956
Status:
UNKNOWN
Last Update Posted:
2023-08-01
First Post:
2022-02-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Brain Substrates for Cardiovascular Stress Physiology
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-09-20', 'releaseDate': '2024-05-18'}, {'resetDate': '2025-07-10', 'releaseDate': '2025-06-22'}], 'estimatedResultsFirstSubmitDate': '2024-05-18'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D015775', 'term': 'Fractures, Stress'}], 'ancestors': [{'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D028022', 'term': 'Low-Level Light Therapy'}], 'ancestors': [{'id': 'D053685', 'term': 'Laser Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D010789', 'term': 'Phototherapy'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-03-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2024-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-07-28', 'studyFirstSubmitDate': '2022-02-21', 'studyFirstSubmitQcDate': '2022-03-25', 'lastUpdatePostDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Oxygen consumption in response to acute psychological stress', 'timeFrame': 'Immediately following intervention (up to 60 minutes)', 'description': 'This measurement takes into account oxygen consumption at baseline and during the stress task.'}, {'measure': 'Heart rate in response to acute psychological stress', 'timeFrame': 'Immediately following intervention (up to 60 minutes)', 'description': 'This measurement takes into account heart rate at baseline and during the stress task.'}, {'measure': 'Additional heart rate in response to acute psychological stress', 'timeFrame': 'Immediately following intervention (up to 60 minutes)', 'description': 'This measurement takes into account additional heart rate at baseline and during stress.'}], 'secondaryOutcomes': [{'measure': 'Perceived stress', 'timeFrame': 'Immediately following intervention (up to 60 minutes)', 'description': 'Ratings of perceived stressfulness (1 = not at all stressful, 7 = very stressful) of the acute psychological stress task'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stress Reaction']}, 'descriptionModule': {'briefSummary': 'Transcranial infrared laser stimulation is a non-invasive neuromodulation technique. The study will examine the effect of transcranial infrared laser stimulation on cardiovascular and metabolic responses to stress.', 'detailedDescription': 'Physiological responses to stress may be a potential pathway by which psychological stress relates to cardiovascular disease. Disproportionate (metabolically exaggerated) stressor-evoked cardiovascular reactions may accelerate atherosclerosis or influence risk of greater cardiovascular disease endpoints. The aim of this project is to use an experimental approach to examine if neuromodulation (transcranial infrared laser stimulation) alters stressor-evoked metabolic and cardiovascular responses.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n18-30 years old\n\nExclusion Criteria:\n\nHistory of a diagnosed chronic medical or neurological disorder Current pregnancy Current illness or infection (e.g., cold, flu) Any condition that would prohibit them from engaging in physical exercise'}, 'identificationModule': {'nctId': 'NCT05298956', 'briefTitle': 'Brain Substrates for Cardiovascular Stress Physiology', 'organization': {'class': 'OTHER', 'fullName': 'Baylor University'}, 'officialTitle': 'Brain Substrates for Cardiovascular Stress Physiology', 'orgStudyIdInfo': {'id': '1437574'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'Sham', 'description': 'Participants will receive sham laser to the right forehead.', 'interventionNames': ['Other: Low-level laser therapy (LLLT)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Transcranial infrared laser stimulation', 'description': 'Participants will receive transcranial infrared laser stimulation to the right forehead.', 'interventionNames': ['Other: Low-level laser therapy (LLLT)']}], 'interventions': [{'name': 'Low-level laser therapy (LLLT)', 'type': 'OTHER', 'description': 'Sham Comparator: Participants will receive 8 counts of 60 seconds of the same laser to the right forehead, however the laser power will be turned off and will be 0 Watts.\n\nTranscranial infrared laser stimulation: Participants will receive 8 counts of 60 seconds of transcranial infrared laser stimulation to the right forehead. The wavelength will be 1064 nm and the laser power will be 3.4 Watts.', 'armGroupLabels': ['Sham', 'Transcranial infrared laser stimulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '76798', 'city': 'Waco', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Annie T. Ginty, PhD', 'role': 'CONTACT', 'email': 'annie_ginty@baylor.edu', 'phone': '254-710-2236'}], 'facility': 'Annie T. Ginty', 'geoPoint': {'lat': 31.54933, 'lon': -97.14667}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Baylor University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Annie Ginty', 'investigatorAffiliation': 'Baylor University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2024-05-18', 'type': 'RELEASE'}, {'date': '2024-09-20', 'type': 'RESET'}, {'date': '2025-06-22', 'type': 'RELEASE'}, {'date': '2025-07-10', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Annie Ginty, Assistant Professor, Baylor University'}}}}