Light Therapy for Moderate Traumatic Brain Injury

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Low Level Light Therapy (LLLT) With Near Infrared Light Emitting Diodes in Patients With Moderate Traumatic Brain Injury (TBI)

Conditions
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Moderate Traumatic Brain Injury (TBI)

Intervention / Treatment
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* Device: Active LLLT helmet application
* Device: Non-active LLLT helmet application


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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. 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Non-active LLLT helmet application<br>A helmet containing near infrared LED's (LLLT helmet) will be applied to the head, however, the LEDs will not be turned on / activated. | Device: Non-active LLLT helmet application<br>* LED helmet applied without light activated<br>|
| Active Comparator: Active LLLT helmet application<br>A helmet containing near infrared LEDs (LLLT helmet) will be applied and the LEDs will be turned on/activated | Device: Active LLLT helmet application<br>* LED helmet applied with light activated<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 = 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. | 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. | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Traumatic brain injury, TBI, Low-level light therapy, LLLT, LLLT helmet