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

Mass General Brigham

Status: Completed

Conditions: Moderate Traumatic Brain Injury (TBI)

Treatments: Device: Active LLLT helmet application; Device: Non-active LLLT helmet application

Study type: Interventional

Funder types: Other

Identifiers

NCT02233413

2013P000430

W81XWH-13-2-0067 CDMRP (Other Grant/Funding Number)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 68 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

68 participants in 2 patient groups

Non-active LLLT helmet application

Sham Comparator group

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.

Treatment:

Device: Non-active LLLT helmet application

Active LLLT helmet application

Active Comparator group

Description:

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

Treatment:

Device: Active LLLT helmet application