Traumatic Brain InjuryNCT06956404
tPBM in Older Adults With Traumatic Brain Injury
A study testing Transcranial photobiomodulator (tPBM) in people with Traumatic Brain Injury, run by NYU Langone Health at 1 site in United States.
Trial 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) Read more about this study
- Who is it for?
- Ages 55 to 85 years
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- Transcranial photobiomodulator (tPBM)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Dec 2025to Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
NYU Langone Health
New York, New York, 10016
About this study
Official title: Transcranial Photobiomodulation in Older Adults With Traumatic Brain Injury: Effects on Cerebral Blood Flow and Cognition
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)
- Conditions
- Traumatic Brain Injury
- Being tested
- Transcranial photobiomodulator (tPBM), Transcranial photobiomodulator (tPBM) in sham mode
- Keywords
- TBI
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial photobiomodulator (tPBM)Device
Also called Transcranial PhotoBioModulation-1000 (tPBM-2.0)
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).
Transcranial photobiomodulator (tPBM) in sham modeDevice
Also called Transcranial PhotoBioModulation-1000 (tPBM-2.0)
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).
| Study group | Role | What they receive |
|---|---|---|
| Active tPBM | Experimental | 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. Receives: Device: Transcranial photobiomodulator (tPBM) |
| Sham tPBM | Sham comparator | 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. Receives: Device: Transcranial photobiomodulator (tPBM) in sham mode |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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)
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.
Measured: Baseline, end-of-treatment (up to 6 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2025
- Study start29 Dec 2025
- Primary completionJul 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- Tamara Bushnik, PhD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06956404
- Sponsor's protocol ID
- 24-00956
- Other IDs
- CDMRP-TP230318
- Status last verified
- Apr 2025
- First submitted
- 24 Apr 2025
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Photobiomodulation in Older Adults With Traumatic Brain Injury: Effects on Cerebral Blood Flow and Cognition
- ClinicalTrials.gov ID
- NCT06956404
- Acronym / sponsor ID
- 24-00956
- Conditions
- Traumatic Brain Injury
- Keywords
- TBI
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 29 Dec 2025 (actual)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 4 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active tPBM | Experimental | Device: Transcranial photobiomodulator (tPBM)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. |
| Sham tPBM | Sham comparator | Device: Transcranial photobiomodulator (tPBM) in sham modeSubjects 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. |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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,
- Between 1 and 2 years post injury.
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial photobiomodulator (tPBM)Also: Transcranial PhotoBioModulation-1000 (tPBM-2.0)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). | Device | Active tPBM |
| Transcranial photobiomodulator (tPBM) in sham modeAlso: Transcranial PhotoBioModulation-1000 (tPBM-2.0)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). | Device | Sham tPBM |
Primary outcome
Change in prefrontal Cerebral Blood Flow (CBF)
Time frame: Baseline, end-of-treatment (up to 6 weeks)
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
Change in Executive Function (EF) composite scores
Time frame: Baseline, end-of-treatment (up to 6 weeks)
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.
1 secondary outcome
Change in number of treatment emergent adverse events as measured by the Systematic Assessment for Treatment Emergent Effects-Systematic Inquiry (SAFTEE-SI)
Time frame: Baseline, end-of-treatment (up to 6 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tamara Bushnik, PhD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial photobiomodulator (tPBM) in people with Traumatic Brain Injury, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tamara Bushnik, PhD (646-565-0468, Tamara.bushnik@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in prefrontal Cerebral Blood Flow (CBF) (time frame: Baseline, end-of-treatment (up to 6 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.