N/A
N=68
Light Therapy for Moderate Traumatic Brain Injury
Moderate Traumatic Brain Injury (TBI)
Bottom Line
View on ClinicalTrials.gov: NCT02233413 ↗Enrolled (actual)
68
Serious AEs
18.6%
Results posted
Dec 2020
Primary outcome: Primary: Safety and Feasibility of Applying Light Therapy After Moderate TBI — 24; 19 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Active LLLT helmet application (Device); Non-active LLLT helmet application (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Jul 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety and Feasibility of Applying Light Therapy After Moderate TBI |
24; 19 | — |
| SECONDARY Neuroreactivity of Light Therapy to the Injured Brain Based on MRI Using the Fazekas Scale for Periventricular White Matter (PVWM) |
19; 18; 3; 1; 1; 0 | — |
| SECONDARY Neuroreactivity of Light Therapy to the Injured Brain Based on MRI Using the Fazekas Scale for Deep White Matter (DWM) |
19; 16; 3; 3; 1; 0 | — |
| SECONDARY Neuroreactivity of Light Therapy to the Injured Brain Based on Neurcognitive Function |
4.55; 3.94; 12.64; 10.94; 17.18; 14.88 | — |
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).
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
Data sourced from ClinicalTrials.gov (NCT02233413). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.