Clinical trial NCT02233413: Light Therapy for Moderate Traumatic Brain Injury
Official title: Low Level Light Therapy (LLLT) With Near Infrared Light Emitting Diodes in Patients With Moderate Traumatic Brain Injury (TBI)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Moderate Traumatic Brain Injury (TBI)
Keywords: Traumatic brain injury
TBI
Low-level light therapy
LLLT
LLLT helmet
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2014-09-08
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Safety and Feasibility of Applying Light Therapy After Moderate TBI
timeFrame: up to seven days after enrollment
Secondary outcomes:
measure: Neuroreactivity of Light Therapy to the Injured Brain Based on MRI Using the Fazekas Scale for Periventricular White Matter (PVWM)
timeFrame: up to 3 months after treatment
measure: Neuroreactivity of Light Therapy to the Injured Brain Based on MRI Using the Fazekas Scale for Deep White Matter (DWM)
timeFrame: up to 3 months after treatment
measure: Neuroreactivity of Light Therapy to the Injured Brain Based on Neurcognitive Function
timeFrame: RPQ scores were collected at approx 72 hours, 14 days, 3 months, and 6 months and the mean was calculated for the values reported.
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Rajiv Gupta, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Massachussetts General Hospital
name: Benjamin Vakoc, PhD
role: STUDY_DIRECTOR
References:
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.