Light Therapy for Moderate Traumatic Brain Injury

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.

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