Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2025-12-25 @ 7:06 PM
Study NCT ID:
NCT06956404
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-05-04
First Post:
2025-04-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
tPBM in Older Adults With Traumatic Brain Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}], 'ancestors': [{'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2028-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-24', 'studyFirstSubmitDate': '2025-04-24', 'studyFirstSubmitQcDate': '2025-04-24', 'lastUpdatePostDateStruct': {'date': '2025-05-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in prefrontal Cerebral Blood Flow (CBF)', 'timeFrame': 'Baseline, end-of-treatment (up to 6 weeks)', 'description': 'CBF will be demonstrated by using arterial spin-labeled (ASL) magnetic resonance imaging (MRI), a method that can reliably quantify absolute CBF level across longer time intervals'}, {'measure': 'Change in Executive Function (EF) composite scores', 'timeFrame': 'Baseline, end-of-treatment (up to 6 weeks)', 'description': 'EF composite scores will be derived from five neuropsychological tests (Repeatable Battery for the Assessment of Neuropsychological Status - RBANS, Stroop Color-Word Test, Controlled Oral Word Association Test/FAS, Trail Making Test-A\\& B) that assess various aspects of EF.'}], 'secondaryOutcomes': [{'measure': 'Change in number of treatment emergent adverse events as measured by the Systematic Assessment for Treatment Emergent Effects-Systematic Inquiry (SAFTEE-SI)', 'timeFrame': 'Baseline, end-of-treatment (up to 6 weeks)', 'description': 'The SAFTEE-SI is a commonly used instrument originally developed by National Institute of Mental Health (NIMH) and adapted into a self-report instrument. The scale examines in a systematic fashion all possible treatment-emergent side effects and probes specific adverse symptoms, including suicidal thoughts and behaviors, and self-injurious behavior.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['TBI'], 'conditions': ['Traumatic Brain Injury']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effect of transcranial photobiomodulation (tPBM) in older patients with chronic traumatic brain injury (TBI). The study aims to examine the effect of tPBM on prefrontal cerebral blood flow (CBF) and executive function (EF)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Able to give written informed consent and follow study procedures.\n2. Age ≥ 55 years and ≤ 85 years.\n3. History of non-penetrating TBI of at least moderate severity,\n\n 1. defined by Emergency Department Glasgow Coma Scale (GCS) \\< 13,\n 2. or post-traumatic amnesia \\> 24 hours,\n 3. or loss of consciousness \\> 30 minutes,\n 4. or evidence of trauma-related abnormality on acute neuroimaging.\n4. Between 1 and 2 years post injury.\n\nExclusion Criteria:\n\n1. Delayed loss of consciousness due to expanding lesions\n2. Diagnosis of dementia, history of brain tumor, or other serious neurological disorder\n3. Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 diagnosis of alcohol or drug use disorder or history of other major psychiatric illness diagnosed with Mini-International Neuropsychiatric Interview (MINI)\n4. History of significant cardiovascular or cerebrovascular pathology before sustaining TBI\n5. Unstable medical conditions or medications impacting cognition (e.g., topiramate)\n6. Significant skin conditions on the subject's scalp in the area of illumination\n7. Large bilateral prefrontal cortex (PFC) lesions (i.e., more than 50% of our middle frontal gyrus region of interest (ROI) in both hemispheres)\n8. Claustrophobia or metallic foreign bodies that would preclude MRI\n9. Unwilling/unable to comply with study as judged by the Principal Investigator\n10. Body mass index \\> 40 kg/m2 to fit comfortably in MRI\n11. Past intolerance or hypersensitivity to tPBM\n12. Any use of light-activated drugs (photodynamic therapy) within 14 days prior to study enrollment"}, 'identificationModule': {'nctId': 'NCT06956404', 'briefTitle': 'tPBM in Older Adults With Traumatic Brain Injury', 'organization': {'class': 'OTHER', 'fullName': 'NYU Langone Health'}, 'officialTitle': 'Transcranial Photobiomodulation in Older Adults With Traumatic Brain Injury: Effects on Cerebral Blood Flow and Cognition', 'orgStudyIdInfo': {'id': '24-00956'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active tPBM', 'description': 'Subjects complete 18 t-PBM treatments, \\~12 min per day, 3 days per week, for 6 weeks. tPBM will be administered via continuous, 808 nm wavelength laser delivery to the forehead at the standard scalp location.', 'interventionNames': ['Device: Transcranial photobiomodulator (tPBM)']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham tPBM', 'description': 'Subjects complete 18 sham treatments, \\~12 min per day, 3 days per week, for 6 weeks. The sham treatment will be administered to the forehead at the standard scalp location.', 'interventionNames': ['Device: Transcranial photobiomodulator (tPBM) in sham mode']}], 'interventions': [{'name': 'Transcranial photobiomodulator (tPBM)', 'type': 'DEVICE', 'otherNames': ['Transcranial PhotoBioModulation-1000 (tPBM-2.0)'], 'description': 'The tPBM-2.0 device consists of a therapeutic laser console (that produces laser energy as NIR), and an optical delivery system consisting of a flexible, double-sheathed optical fiber connected to a custom helmet (cap). tPBM will be administered via continuous, 808 nm wavelength laser delivery to the forehead at the standard scalp location \\~12 minutes per day, 3 days per week, for 6 weeks (18 total sessions).', 'armGroupLabels': ['Active tPBM']}, {'name': 'Transcranial photobiomodulator (tPBM) in sham mode', 'type': 'DEVICE', 'otherNames': ['Transcranial PhotoBioModulation-1000 (tPBM-2.0)'], 'description': 'The tPBM-2.0 device consists of a therapeutic laser console (which will be in sham mode, which does not produce laser energy), and an optical delivery system consisting of a flexible, double-sheathed optical fiber connected to a custom helmet (cap).', 'armGroupLabels': ['Sham tPBM']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'NYU Langone Health', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'centralContacts': [{'name': 'Tamara Bushnik, PhD', 'role': 'CONTACT', 'email': 'Tamara.bushnik@nyulangone.org', 'phone': '646-565-0468'}, {'name': 'Michelle Smith', 'role': 'CONTACT', 'email': 'Michelle.smith@nyulangone.org', 'phone': '646-501-9162'}], 'overallOfficials': [{'name': 'Tamara Bushnik, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NYU Langone Health'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.', 'ipdSharing': 'YES', 'description': "The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: jkim@med.cuny.edu. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.", 'accessCriteria': "The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to jkim@med.cuny.edu. To gain access, data requestors will need to sign a data access agreement. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's DSSB."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NYU Langone Health', 'class': 'OTHER'}, 'collaborators': [{'name': 'United States Department of Defense', 'class': 'FED'}], 'responsibleParty': {'type': 'SPONSOR'}}}}