Traumatic Brain InjuryLED-TBINCT02404402
LED Treatment to Improve Cognition and Promote Recovery in TBI
A study testing LED in people with Traumatic Brain Injury and Posttraumatic Stress Disorder, run by VA Office of Research and Development at 1 site in United States.
Trial summary
This study investigates the efficacy of a novel neuromodulation treatment, light emitting diodes (LED), on cognition, neuropsychiatric status and quality of life in individuals with traumatic brain injury (TBI). Read more about this study
- Who is it for?
- Ages 21 to 55 years
- Conditions the study is for
- Traumatic Brain Injury, Posttraumatic Stress Disorder
- What is being tested?
- LED
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2015to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 21 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- OEF/OIF active-duty personnel or Veterans with history of TBI or blast-exposure
- Meets criteria for mild TBI
- LOC of 30 min or less
- Age: 21-55
- Primary language is English
Who cannot join
- Evidence of penetrating head injury
- History of previous neurological diagnosis
- History of previous psychotic disorder prior to TBI
- Hearing or vision impairment
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, 02130-4817
About this study
Official title: Noninvasive LED Treatment to Improve Cognition and Promote Recovery in Blast TBI
This study investigates the efficacy of a novel neuromodulation treatment, light emitting diodes (LED), on cognition, neuropsychiatric status and quality of life in individuals with traumatic brain injury (TBI).
Read the detailed description
The most common traumatic brain injury (TBI)-associated problems are cognitive deficits and neuropsychiatric problems, such as sleep disturbance and PTSD. This study evaluates a novel neuromodulation intervention, light emitting diodes (LED), for treatment of patients with TBI. LED is a noninvasive, non-thermal, painless treatment, which does not involve any needles or any form of surgery. LED treatment improves cellular activity of the brain tissue that has been damaged by TBI. Half of the study participants will receive active LED treatment, and a control group will receive sham LED. This study takes place in Boston, Massachusetts: at the VA Boston Healthcare System.
- Being tested
- LED, sham LED
- Keywords
- Traumatic Brain Injury, Light Emitting Diodes, Cognition, Neuromodulation, PTSD, Neurorehabilitation, Veterans, Sleep
- Medical subject headings
- Brain Injuries, Traumatic, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LEDOther
Low Level Light Therapy
sham LEDOther
Inactive (sham) LED treatment
| Study group | Role | What they receive |
|---|---|---|
| Active LED | Experimental | Active LED Treatment Receives: Other: LED |
| Sham LED | Sham comparator | Inactive (sham) LED Treatment Receives: Other: sham LED |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive Functioning_Attention/Executive
Stroop Test ("Color-Word" test; Delis, Kaplan \& Kramer, 2001)
Measured: Eight Weeks
Cognitive Functioning_Learning/Memory
California Verbal Learning Test-II (CVLT-II; Delis, Kramer, Kaplan, \& Ober, 2000)
Measured: Eight weeks
Secondary outcomes (3)
Neuropsychiatric Status/Mood
Beck Depression inventory (BDI; Beck, 2006)
Measured: Eight weeks
Neuropsychiatric status/PTSD
PTSD Checklist - Military Version (PCL-M)
Measured: Eight weeks
Neuropsychiatric status/Sleep
Pittsburgh Sleep Quality Index (PSQI; Buysse et al., 1989)
Measured: Eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2015 (estimated)
- Study start1 May 2015
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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, Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Yelena Bogdanova, PhD PhD, Principal investigator, VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02404402
- Sponsor's protocol ID
- N1773-P
- Acronym
- LED-TBI
- Status last verified
- Apr 2026
- First submitted
- 25 Feb 2015
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Naeser MA, Martin PI, Ho MD, Krengel MH, Bogdanova Y, Knight JA, Yee MK, Zafonte R, Frazier J, Hamblin MR, Koo BB. Transcranial, Red/Near-Infrared Light-Emitting Diode Therapy to Improve Cognition in Chronic Traumatic Brain Injury. Photomed Laser Surg. 2016 Dec;34(12):610-626. doi: 10.1089/pho.2015.4037.
PubMed 28001756
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noninvasive LED Treatment to Improve Cognition and Promote Recovery in Blast TBI
- ClinicalTrials.gov ID
- NCT02404402
- Acronym / sponsor ID
- LED-TBI / N1773-P
- Keywords
- Traumatic Brain Injury, Light Emitting Diodes, Cognition, Neuromodulation, PTSD, Neurorehabilitation, Veterans, Sleep
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 May 2015 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 31 Mar 2015 (estimated)
- 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.
This study investigates the efficacy of a novel neuromodulation treatment, light emitting diodes (LED), on cognition, neuropsychiatric status and quality of life in individuals with traumatic brain injury (TBI).
Detailed description
The most common traumatic brain injury (TBI)-associated problems are cognitive deficits and neuropsychiatric problems, such as sleep disturbance and PTSD. This study evaluates a novel neuromodulation intervention, light emitting diodes (LED), for treatment of patients with TBI. LED is a noninvasive, non-thermal, painless treatment, which does not involve any needles or any form of surgery. LED treatment improves cellular activity of the brain tissue that has been damaged by TBI. Half of the study participants will receive active LED treatment, and a control group will receive sham LED. This study takes place in Boston, Massachusetts: at the VA Boston Healthcare System.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active LED | Experimental | Other: LEDActive LED Treatment |
| Sham LED | Sham comparator | Other: sham LEDInactive (sham) LED Treatment |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- OEF/OIF active-duty personnel or Veterans with history of TBI or blast-exposure
- Meets criteria for mild TBI
- LOC of 30 min or less
- Age: 21-55
- Primary language is English
Key exclusion criteria (4 listed)
- Evidence of penetrating head injury
- History of previous neurological diagnosis
- History of previous psychotic disorder prior to TBI
- Hearing or vision impairment
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 |
|---|---|---|
| LEDLow Level Light Therapy | Other | Active LED |
| sham LEDInactive (sham) LED treatment | Other | Sham LED |
Primary outcome
Cognitive Functioning_Attention/Executive
Time frame: Eight Weeks
Stroop Test ("Color-Word" test; Delis, Kaplan \& Kramer, 2001)
Cognitive Functioning_Learning/Memory
Time frame: Eight weeks
California Verbal Learning Test-II (CVLT-II; Delis, Kramer, Kaplan, \& Ober, 2000)
3 secondary outcomes
Neuropsychiatric Status/Mood
Time frame: Eight weeks
Neuropsychiatric status/PTSD
Time frame: Eight weeks
Neuropsychiatric status/Sleep
Time frame: Eight weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Results publication: PubMed 28001756Naeser MA, Martin PI, Ho MD, Krengel MH, Bogdanova Y, Knight JA, Yee MK, Zafonte R, Frazier J, Hamblin MR, Koo BB. Transcranial, Red/Near-Infrared Light-Emitting Diode Therapy to Improve Cognition in Chronic Traumatic Brain Injury. Photomed Laser Surg. 2016 Dec;34(12):610-626. doi: 10.1089/pho.2015.4037.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Yelena Bogdanova, PhD PhD principal investigator
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LED in people with Traumatic Brain Injury and Posttraumatic Stress Disorder, run by VA Office of Research and Development 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 5 inclusion and 4 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: finished, as of the sponsor's last update on 15 Apr 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive Functioning_Attention/Executive (time frame: Eight 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?
On the ClinicalTrials.gov record for NCT02404402, which also lists 1 linked publication.
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 Apr 2026.