Light Therapy for Moderate Traumatic Brain Injury

Massachusetts General Hospital68 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

TRIPLE

Enrollment

Conditions

Moderate Traumatic Brain Injury (TBI)

Interventions

Active LLLT helmet applicationDEVICE

LED helmet applied with light activated

Non-active LLLT helmet applicationDEVICE

LED helmet applied without light activated

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Massachusetts General Hospital

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

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.

Time frame: up to seven days after enrollment

Secondary Outcomes

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 1. = "caps" or pencil-thin lining 2. = smooth "halo" 3. = 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.

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)

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 1. = punctate foci 2. = beginning confluence 3. = 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.

Time frame: 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

Data from ClinicalTrials.gov

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