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| ID | Type | Description | Link |
|---|---|---|---|
| W81XWH-13-2-0067 CDMRP | Other Grant/Funding Number | Department of Defense |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active LLLT helmet application | Device | LED helmet applied with light activated |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | up to seven days after enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| 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
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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rajiv Gupta, MD, PhD | Massachusetts General Hospital | Principal Investigator |
| Benjamin Vakoc, PhD | Massachussetts General Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38805733 | Derived | 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. | |
| 32926117 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Non-active LLLT Helmet Application | A helmet containing near infrared LED's (LLLT helmet) will be applied to the head, however, the LEDs will not be turned on / activated. Non-active LLLT helmet application: LED helmet applied without light activated |
| FG001 | Active LLLT Helmet Application | A helmet containing near infrared LEDs (LLLT helmet) will be applied and the LEDs will be turned on/activated Active LLLT helmet application: LED helmet applied with light activated |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Non-active LLLT Helmet Application | A helmet containing near infrared LED's (LLLT helmet) will be applied to the head, however, the LEDs will not be turned on / activated. Non-active LLLT helmet application: LED helmet applied without light activated |
| BG001 | Active LLLT Helmet Application |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Subjects who completed light or sham treatment and at least one MRI scan. 43 patients completed the study with at least one MRI scan, 19 subjects in the Light treatment group and 24 subjects in the sham treatment group. | Posted | Count of Participants | Participants | up to seven days after enrollment |
|
Adverse events were monitored/assessed during study enrollment through study completion, an average of 1 year.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Non-active LLLT Helmet Application | A helmet containing near infrared LED's (LLLT helmet) will be applied to the head, however, the LEDs will not be turned on / activated. Non-active LLLT helmet application: LED helmet applied without light activated |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Operation for tibial & fibular fracture | Surgical and medical procedures | Non-systematic Assessment | Severe, unexpected, unrelated. Subject came back for scheduled operation due to nonunion left distal tibial & fibular fracture |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Symptom reporting | Nervous system disorders | Systematic Assessment | Reporting of one or more of the following: Headache, blurred vision, double vision, dizziness, numbness, NV, ringing, noise, light, forgetfulness, thinking, concentrating, irritable, frustrated, restless, sleeping, fatigue, depressed. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Rajiv Gupta | Massachusetts General Hospital | 617-726-0369 | rgupta1@mgh.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 13, 2018 | Jul 30, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 26, 2020 | Jul 30, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Non-active LLLT helmet application | Device | LED helmet applied without light activated |
|
| 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
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. | 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 | RPQ scores were collected at approx 72 hours, 14 days, 3 months, and 6 months and the mean was calculated for the values reported. |
| Derived |
| Figueiro 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. |
A helmet containing near infrared LEDs (LLLT helmet) will be applied and the LEDs will be turned on/activated Active LLLT helmet application: LED helmet applied with light activated |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Injury Mechanism | Count of Participants | Participants |
|
| Active LLLT Helmet Application |
A helmet containing near infrared LEDs (LLLT helmet) will be applied and the LEDs will be turned on/activated Active LLLT helmet application: LED helmet applied with light activated |
|
|
| Secondary | 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
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. | Of the 68 patients that were randomized, 28 completed at least one light therapy session. 43 patients completed the study with at least one MRI scan. 19 subjects in the light treatment group and 24 subjects in the sham treatment group. One MRI was deemed low quality and excluded from analysis (19 light treatment / 23 sham) | Posted | Count of Participants | Participants | up to 3 months after treatment |
|
|
|
| Secondary | 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
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. | Posted | Count of Participants | Participants | up to 3 months after treatment |
|
|
|
| Secondary | 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 | Posted | Mean | Standard Deviation | score on a scale | RPQ scores were collected at approx 72 hours, 14 days, 3 months, and 6 months and the mean was calculated for the values reported. |
|
|
|
| 0 |
| 31 |
| 7 |
| 31 |
| 20 |
| 31 |
| EG001 | Active LLLT Helmet Application | A helmet containing near infrared LEDs (LLLT helmet) will be applied and the LEDs will be turned on/activated Active LLLT helmet application: LED helmet applied with light activated | 0 | 28 | 4 | 28 | 13 | 28 |
|
| Subdural hematoma | Nervous system disorders | Non-systematic Assessment | Severe, expected, unrelated. During data review a SDH was discovered on study MRI which was not present on clinical CT. |
|
| Pancreatitis | Gastrointestinal disorders | Non-systematic Assessment | Severe, unexpected, unrelated. Subject came back to hospital due to pancreatitis |
|
| MSSA bacteremia | Infections and infestations | Non-systematic Assessment | Severe, unexpected, unrelated. Subject went back to hospital due to MSSA bacteremia |
|
| COPD exacerbation | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Severe, unexpected, unrelated. Subject went back to hospital due to COPD exacerbation. |
|
| Hospital visit due to headache | Nervous system disorders | Non-systematic Assessment | Severe, expected, unrelated. |
|
| Suicidal Ideation | Psychiatric disorders | Non-systematic Assessment | Severe, unexpected, unrelated. Subject went back to hospital due to suicidal ideation in the setting of intermittent depressive symptoms over years, chronic pain, and other difficulties. Evaluated and cleared by psychiatry. |
|
| Hemorrhagic cystitis | Renal and urinary disorders | Non-systematic Assessment | Severe, unexpected, unrelated. Subject went back to hospital due to hemorrhagic cystitis. |
|
| Rectal foreign body | Surgical and medical procedures | Non-systematic Assessment | Severe, unexpected, unrelated. Subject went back to hospital due to rectal foreign body |
|
|
| Persistent cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Subject visited urgent care for persistent cough |
|
| Numbness/tingling in toes | Nervous system disorders | Non-systematic Assessment | Subject reported numbness/tingling in toes 1 week to 3 month time point |
|
| Glass from motor vehicle accident removed | Surgical and medical procedures | Non-systematic Assessment | Subject went back to hospital to have glass from motor vehicle accident removed from skin on forehead. |
|
| Broken nose | Surgical and medical procedures | Non-systematic Assessment | Subject went back to hospital to have broken nose corrected. |
|
| Fracture repair | Surgical and medical procedures | Non-systematic Assessment | Subject went back to hospital for repair of zygomaticomaxillary complex (ZMC) and orbital floor fractures. |
|
| Alcohol abuse | Social circumstances | Non-systematic Assessment | Subject went back to hospital due to alcohol abuse/intoxication. |
|
| Musculoskeletal neck pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Subject went back to hospital due to neck pain. |
|
| Fall | Social circumstances | Non-systematic Assessment | Subject went back to hospital due to fall |
|
| Dislocated shoulder | Surgical and medical procedures | Non-systematic Assessment | Subject went back to hospital for dislocated shoulder |
|
| Cataract surgery | Eye disorders | Non-systematic Assessment | Subject went back to hospital for cataract surgery |
|
| Dizziness | Nervous system disorders | Non-systematic Assessment | Subject went back to hospital due to dizziness |
|
| Shoulder sprain | Surgical and medical procedures | Non-systematic Assessment | Subject returned to hospital due to motor vehicle accident with diagnosis of shoulder sprain |
|
| Hemorrhagic cyst | Reproductive system and breast disorders | Non-systematic Assessment | Hemorrhagic cyst |
|
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| D006259 |
| Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| PVWM: Irregular periventricular signal (3) |
|
| DWM: Large confluent areas |
|
| RPQ-Total |
|