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Light Therapy for Moderate Traumatic Brain Injury (LLLT for TBI)

Primary Purpose

Moderate Traumatic Brain Injury (TBI)

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Active LLLT helmet application
Non-active LLLT helmet application
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Moderate Traumatic Brain Injury (TBI) focused on measuring Traumatic brain injury, TBI, Low-level light therapy, LLLT, LLLT helmet

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Active Comparator

Arm Label

Non-active LLLT helmet application

Active LLLT helmet application

Arm Description

A helmet containing near infrared LED's (LLLT helmet) will be applied to the head, however, the LEDs will not be turned on / activated.

A helmet containing near infrared LEDs (LLLT helmet) will be applied and the LEDs will be turned on/activated

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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

Full Information

First Posted
June 5, 2014
Last Updated
November 10, 2020
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02233413
Brief Title
Light Therapy for Moderate Traumatic Brain Injury
Acronym
LLLT for TBI
Official Title
Low Level Light Therapy (LLLT) With Near Infrared Light Emitting Diodes in Patients With Moderate Traumatic Brain Injury (TBI)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
July 31, 2019 (Actual)
Study Completion Date
July 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Moderate Traumatic Brain Injury (TBI)
Keywords
Traumatic brain injury, TBI, Low-level light therapy, LLLT, LLLT helmet

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Non-active LLLT helmet application
Arm Type
Sham Comparator
Arm Description
A helmet containing near infrared LED's (LLLT helmet) will be applied to the head, however, the LEDs will not be turned on / activated.
Arm Title
Active LLLT helmet application
Arm Type
Active Comparator
Arm Description
A helmet containing near infrared LEDs (LLLT helmet) will be applied and the LEDs will be turned on/activated
Intervention Type
Device
Intervention Name(s)
Active LLLT helmet application
Intervention Description
LED helmet applied with light activated
Intervention Type
Device
Intervention Name(s)
Non-active LLLT helmet application
Intervention Description
LED helmet applied without light activated
Primary Outcome Measure Information:
Title
Safety and Feasibility of Applying Light Therapy After Moderate TBI
Description
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 Outcome Measure Information:
Title
Neuroreactivity of Light Therapy to the Injured Brain Based on MRI Using the Fazekas Scale for Periventricular White Matter (PVWM)
Description
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.
Time Frame
up to 3 months after treatment
Title
Neuroreactivity of Light Therapy to the Injured Brain Based on MRI Using the Fazekas Scale for Deep White Matter (DWM)
Description
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.
Time Frame
up to 3 months after treatment
Title
Neuroreactivity of Light Therapy to the Injured Brain Based on Neurcognitive Function
Description
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
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rajiv Gupta, MD, PhD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Benjamin Vakoc, PhD
Organizational Affiliation
Massachussetts General Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
32926117
Citation
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.
Results Reference
derived

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Light Therapy for Moderate Traumatic Brain Injury

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