tPBM in Older Adults With Traumatic Brain Injury
Transcranial Photobiomodulation in Older Adults With Traumatic Brain Injury: Effects on Cerebral Blood Flow and Cognition
2 other identifiers
interventional
70
1 country
1
Brief Summary
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2025
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 24, 2025
CompletedFirst Posted
Study publicly available on registry
May 4, 2025
CompletedStudy Start
First participant enrolled
December 29, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2028
January 15, 2026
April 1, 2025
2.5 years
April 24, 2025
January 14, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in prefrontal Cerebral Blood Flow (CBF)
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
Baseline, end-of-treatment (up to 6 weeks)
Change in Executive Function (EF) composite scores
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.
Baseline, end-of-treatment (up to 6 weeks)
Secondary Outcomes (1)
Change in number of treatment emergent adverse events as measured by the Systematic Assessment for Treatment Emergent Effects-Systematic Inquiry (SAFTEE-SI)
Baseline, end-of-treatment (up to 6 weeks)
Study Arms (2)
Active tPBM
EXPERIMENTALSubjects 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.
Sham tPBM
SHAM COMPARATORSubjects 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.
Interventions
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).
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).
Eligibility Criteria
You may qualify if:
- Able to give written informed consent and follow study procedures.
- Age ≥ 55 years and ≤ 85 years.
- History of non-penetrating TBI of at least moderate severity,
- defined by Emergency Department Glasgow Coma Scale (GCS) \< 13,
- or post-traumatic amnesia \> 24 hours,
- or loss of consciousness \> 30 minutes,
- or evidence of trauma-related abnormality on acute neuroimaging.
- Between 1 and 2 years post injury.
You may not qualify if:
- Delayed loss of consciousness due to expanding lesions
- Diagnosis of dementia, history of brain tumor, or other serious neurological disorder
- 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)
- History of significant cardiovascular or cerebrovascular pathology before sustaining TBI
- Unstable medical conditions or medications impacting cognition (e.g., topiramate)
- Significant skin conditions on the subject's scalp in the area of illumination
- Large bilateral prefrontal cortex (PFC) lesions (i.e., more than 50% of our middle frontal gyrus region of interest (ROI) in both hemispheres)
- Claustrophobia or metallic foreign bodies that would preclude MRI
- Unwilling/unable to comply with study as judged by the Principal Investigator
- Body mass index \> 40 kg/m2 to fit comfortably in MRI
- Past intolerance or hypersensitivity to tPBM
- Any use of light-activated drugs (photodynamic therapy) within 14 days prior to study enrollment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- United States Department of Defensecollaborator
- NYU Langone Healthlead
Study Sites (1)
NYU Langone Health
New York, New York, 10016, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tamara Bushnik, PhD
NYU Langone Health
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 24, 2025
First Posted
May 4, 2025
Study Start
December 29, 2025
Primary Completion (Estimated)
July 1, 2028
Study Completion (Estimated)
July 1, 2028
Last Updated
January 15, 2026
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
- Access Criteria
- 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.
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.