Light Therapy for Moderate Traumatic Brain Injury

Completed · Not applicable

Conditions studied: Moderate Traumatic Brain Injury (TBI)

In brief

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).

Key facts

Study ID

NCT02233413

Run by

Massachusetts General Hospital

People needed

68

Starts

2014-06-01

Expected to finish

2020-07-01

Last updated by the study team

2020-12-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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