Moderate Traumatic Brain Injury (TBI)LLLT for TBINCT02233413
Light Therapy for Moderate Traumatic Brain Injury
A study testing Active LLLT helmet application and Non-active LLLT helmet application in people with Moderate Traumatic Brain Injury (TBI), run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The purpose of this research study is to find out if a specialized helmet that provides low levels of near infrared light, also known as low-level light therapy (LLLT) has any effect on the recovery of people who have recently (within 72h) suffered a moderate traumatic brain injury (TBI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Moderate Traumatic Brain Injury (TBI)
- What is being tested?
- Active LLLT helmet application and Non-active LLLT helmet application
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to Jul 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years old;
- Injury within 72 hours at the time of consent;
- Head injury requiring hospital admission;
- A Glasgow Coma Scale (GCS) score of 9-12 or 13-15 with abnormal imaging.
Who cannot join
- Need for emergency neurosurgical intervention (including placement of intracranial pressure monitoring devices or drainage catheters);
- Hemodynamic instability as determined by the clinician;
- History of any of the following: (i) brain tumor; (ii) prior TBI occurring within the past year and requiring hospital admission; (iii) a new diagnosis within the past year of either stroke or epilepsy; (iv) an established diagnosis of any of the following neurodegenerative diseases: Alzheimer's, Picks, Parkinson's, Lewy body dementia, Huntington's, amytropic lateral sclerosis, spinocerebellar ataxia, vascular dementia, HIZ-associated dementia, dementia due to metabolic causes (Addison, Cushing, hypothyroidism, renal failure, prophyrias, Wilson, mitochondrial diseases, Wernicke-Korsakoff syndrome, and dementia of unknown etiology.
- Pregnancy (all women of child-bearing age will need to have a negative pregnancy test prior to the start of the interventional portion of the study);
- Electrical implants such as cardiac pacemakers or perfusion pumps;
- Ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, tattoos near the eye, or steel implants, or any other contra-indications to MRI.
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- Clinical determination that subject cannot undergo MRI
- Breastfeeding
- Unstable cervical fractures
- Scalp lacerations or surgical wounds severe enough to preclude safe application of device
- Unreliable to follow up
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Low Level Light Therapy (LLLT) With Near Infrared Light Emitting Diodes in Patients With Moderate Traumatic Brain Injury (TBI)
The purpose of this research study is to find out if a specialized helmet that provides low levels of near infrared light, also known as low-level light therapy (LLLT) has any effect on the recovery of people who have recently (within 72h) suffered a moderate traumatic brain injury (TBI).
Read the detailed description
The specific aim of this pilot study is to determine the feasibility of using the LLLT helmet in patients with moderate TBI and to quantify the response to LLLT using magnetic resonance (MR) and clinical outcome measures. We hypothesize that we will be able to quantify the response to LLLT through MR imaging and clinical outcome measures.
- Conditions
- Moderate Traumatic Brain Injury (TBI)
- Being tested
- Active LLLT helmet application, Non-active LLLT helmet application
- Keywords
- Traumatic brain injury, TBI, Low-level light therapy, LLLT, LLLT helmet
- 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.
Active LLLT helmet applicationDevice
LED helmet applied with light activated
Non-active LLLT helmet applicationDevice
LED helmet applied without light activated
| Study group | Role | What they receive |
|---|---|---|
| Non-active LLLT helmet application | Sham comparator | A helmet containing near infrared LED's (LLLT helmet) will be applied to the head, however, the LEDs will not be turned on / activated. Receives: Device: Non-active LLLT helmet application |
| Active LLLT helmet application | Active comparator | A helmet containing near infrared LEDs (LLLT helmet) will be applied and the LEDs will be turned on/activated Receives: Device: Active LLLT helmet application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Feasibility of Applying Light Therapy After Moderate TBI
Number of subjects to successfully complete light therapy without serious unanticipated adverse events related to application of the device.
Measured: up to seven days after enrollment
Secondary outcomes (3)
Neuroreactivity of Light Therapy to the Injured Brain Based on MRI Using the Fazekas Scale for Periventricular White Matter (PVWM)
The presence of chronic white matter disease was evaluated using Fazekas scale. The scale divides the white matter in periventricular and deep white matter, and each region is given a grade depending on the size and confluence of lesions.
periventricular white matter (PVWM). 0 = absent
- = "caps" or pencil-thin lining
- = smooth "halo"
- = irregular periventricular signal extending into the deep white matter
A neuroradiologist evaluated the 3D T2-SPACE-FLAIR images to detect the presence of T2 hyperintensities and their degree (0: absent; 1: mild; 2: moderate; and 3: severe) for PVWM. Higher values represent a worse outcome.
Measured: up to 3 months after treatment
Neuroreactivity of Light Therapy to the Injured Brain Based on MRI Using the Fazekas Scale for Deep White Matter (DWM)
The presence of chronic white matter disease was evaluated using Fazekas scale. The scale divides the white matter in periventricular and deep white matter, and each region is given a grade depending on the size and confluence of lesions.
deep white matter (DWM) 0 = absent
- = punctate foci
- = beginning confluence
- = large confluent areas
A neuroradiologist evaluated the 3D T2-SPACE-FLAIR images to detect the presence of T2 hyperintensities and their degree (0: absent; 1: mild; 2: moderate; and 3: severe) for DWM. Higher values represent a worse outcome.
Measured: up to 3 months after treatment
Neuroreactivity of Light Therapy to the Injured Brain Based on Neurcognitive Function
RPQ is a 16 item self-assessment questionnaire completed via an in-person or phone interview. Each item in the questionnaire is assessed on a 5-point scale ranging from 0 (no problem) - 4 (severe problem). The questions are grouped in two non-overlapping sets: the RPQ-3 includes early, objective, physical symptoms, and the RPQ-13 group includes later, more cognitive and behavioral symptoms. The RPQ-3 encompasses headache, dizziness, and nausea/vomiting. The RPQ-13 includes questions evaluating noise sensitivity, sleep disturbance, fatigue, irritability, depressed mood, forgetfulness, poor concentration, longer thinking time, blurred vision, light sensitivity, double vision, and restlessness. The RPQ-3 ranges from 0 - 12 (best to worst) and RPQ-13 ranges from 0 - 52 (best to worst). RPQ Total is the theoretical max/min RPQ score with a combined possible score ranging from 0-64 (best to worst). The outcome measures are
Measured: RPQ scores were collected at approx 72 hours, 14 days, 3 months, and 6 months and the mean was calculated for the values reported.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2014 (estimated)
- Study startJun 2014
- Primary completion31 Jul 2019
- Study completionJul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Moderate Traumatic Brain Injury (TBI)Studies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rajiv Gupta, Massachusetts General Hospital
- Investigators
- Rajiv Gupta, MD, PhD, Principal investigator, Massachusetts General HospitalBenjamin Vakoc, PhD, Study director, Massachussetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02233413
- Sponsor's protocol ID
- 2013P000430
- Other IDs
- W81XWH-13-2-0067 CDMRP
- Acronym
- LLLT for TBI
- Status last verified
- Nov 2020
- First submitted
- 5 Jun 2014
- Last updated
- 3 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Chan ST, Mercaldo N, Figueiro Longo MG, Welt J, Avesta A, Lee J, Lev MH, Ratai EM, Wenke MR, Parry BA, Drake L, Anderson RR, Rauch T, Diaz-Arrastia R, Kwong KK, Hamblin M, Vakoc BJ, Gupta R. Effects of Low-Level Light Therapy on Resting-State Connectivity Following Moderate Traumatic Brain Injury: Secondary Analyses of a Double-blinded Placebo-controlled Study. Radiology. 2024 May;311(2):e230999. doi: 10.1148/radiol.230999.
PubMed 38805733Figueiro Longo MG, Tan CO, Chan ST, Welt J, Avesta A, Ratai E, Mercaldo ND, Yendiki A, Namati J, Chico-Calero I, Parry BA, Drake L, Anderson R, Rauch T, Diaz-Arrastia R, Lev M, Lee J, Hamblin M, Vakoc B, Gupta R. Effect of Transcranial Low-Level Light Therapy vs Sham Therapy Among Patients With Moderate Traumatic Brain Injury: A Randomized Clinical Trial. JAMA Netw Open. 2020 Sep 1;3(9):e2017337. doi: 10.1001/jamanetworkopen.2020.17337.
PubMed 32926117
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Level Light Therapy (LLLT) With Near Infrared Light Emitting Diodes in Patients With Moderate Traumatic Brain Injury (TBI)
- ClinicalTrials.gov ID
- NCT02233413
- Acronym / sponsor ID
- LLLT for TBI / 2013P000430
- Conditions
- Moderate Traumatic Brain Injury (TBI)
- Keywords
- Traumatic brain injury, TBI, Low-level light therapy, LLLT, LLLT helmet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- Jul 2020 (actual)
- First posted
- 8 Sep 2014 (estimated)
- Results
- Posted 3 Dec 2020
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 research study is to find out if a specialized helmet that provides low levels of near infrared light, also known as low-level light therapy (LLLT) has any effect on the recovery of people who have recently (within 72h) suffered a moderate traumatic brain injury (TBI).
Detailed description
The specific aim of this pilot study is to determine the feasibility of using the LLLT helmet in patients with moderate TBI and to quantify the response to LLLT using magnetic resonance (MR) and clinical outcome measures. We hypothesize that we will be able to quantify the response to LLLT through MR imaging and clinical outcome measures.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-active LLLT helmet application | Sham comparator | Device: Non-active LLLT helmet applicationA helmet containing near infrared LED's (LLLT helmet) will be applied to the head, however, the LEDs will not be turned on / activated. |
| Active LLLT helmet application | Active comparator | Device: Active LLLT helmet applicationA helmet containing near infrared LEDs (LLLT helmet) will be applied and the LEDs will be turned on/activated |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- At least 18 years old;
- Injury within 72 hours at the time of consent;
- Head injury requiring hospital admission;
- A Glasgow Coma Scale (GCS) score of 9-12 or 13-15 with abnormal imaging.
Key exclusion criteria (11 listed)
- Need for emergency neurosurgical intervention (including placement of intracranial pressure monitoring devices or drainage catheters);
- Hemodynamic instability as determined by the clinician;
- History of any of the following: (i) brain tumor; (ii) prior TBI occurring within the past year and requiring hospital admission; (iii) a new diagnosis within the past year of either stroke or epilepsy; (iv) an established diagnosis of any of the following neurodegenerative diseases: Alzheimer's, Picks, Parkinson's, Lewy body dementia, Huntington's, amytropic lateral sclerosis, spinocerebellar ataxia, vascular dementia, HIZ-associated dementia, dementia due to metabolic causes (Addison, Cushing, hypothyroidism, renal failure, prophyrias, Wilson, mitochondrial diseases, Wernicke-Korsakoff syndrome, and dementia of unknown etiology.
- Pregnancy (all women of child-bearing age will need to have a negative pregnancy test prior to the start of the interventional portion of the study);
- Electrical implants such as cardiac pacemakers or perfusion pumps;
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 |
|---|---|---|
| Active LLLT helmet applicationLED helmet applied with light activated | Device | Active LLLT helmet application |
| Non-active LLLT helmet applicationLED helmet applied without light activated | Device | Non-active LLLT helmet application |
Primary outcome
Safety and Feasibility of Applying Light Therapy After Moderate TBI
Time frame: up to seven days after enrollment
Number of subjects to successfully complete light therapy without serious unanticipated adverse events related to application of the device.
3 secondary outcomes
Neuroreactivity of Light Therapy to the Injured Brain Based on MRI Using the Fazekas Scale for Periventricular White Matter (PVWM)
Time frame: up to 3 months after treatment
Neuroreactivity of Light Therapy to the Injured Brain Based on MRI Using the Fazekas Scale for Deep White Matter (DWM)
Time frame: up to 3 months after treatment
Neuroreactivity of Light Therapy to the Injured Brain Based on Neurcognitive Function
Time frame: RPQ scores were collected at approx 72 hours, 14 days, 3 months, and 6 months and the mean was calculated for the values reported.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38805733Chan ST, Mercaldo N, Figueiro Longo MG, Welt J, Avesta A, Lee J, Lev MH, Ratai EM, Wenke MR, Parry BA, Drake L, Anderson RR, Rauch T, Diaz-Arrastia R, Kwong KK, Hamblin M, Vakoc BJ, Gupta R. Effects of Low-Level Light Therapy on Resting-State Connectivity Following Moderate Traumatic Brain Injury: Secondary Analyses of a Double-blinded Placebo-controlled Study. Radiology. 2024 May;311(2):e230999. doi: 10.1148/radiol.230999.
- Derived from this study: PubMed 32926117Figueiro Longo MG, Tan CO, Chan ST, Welt J, Avesta A, Ratai E, Mercaldo ND, Yendiki A, Namati J, Chico-Calero I, Parry BA, Drake L, Anderson R, Rauch T, Diaz-Arrastia R, Lev M, Lee J, Hamblin M, Vakoc B, Gupta R. Effect of Transcranial Low-Level Light Therapy vs Sham Therapy Among Patients With Moderate Traumatic Brain Injury: A Randomized Clinical Trial. JAMA Netw Open. 2020 Sep 1;3(9):e2017337. doi: 10.1001/jamanetworkopen.2020.17337.
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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.
Rajiv Gupta, MD, PhD principal investigator
Massachusetts General Hospital
Benjamin Vakoc, PhD study director
Massachussetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active LLLT helmet application and Non-active LLLT helmet application in people with Moderate Traumatic Brain Injury (TBI), run by Massachusetts General Hospital 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 4 inclusion and 11 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 3 Dec 2020. 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?
Yes. Results are posted in the registry (first posted 3 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Safety and Feasibility of Applying Light Therapy After Moderate TBI (time frame: up to seven days after enrollment). 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 NCT02233413, which also lists 2 linked publications.
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 3 Dec 2020.