Light Therapy for Moderate Traumatic Brain Injury (LLLT for TBI)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02233413|
Recruitment Status : Recruiting
First Posted : September 8, 2014
Last Update Posted : May 17, 2018
|Condition or disease||Intervention/treatment||Phase|
|Moderate Traumatic Brain Injury (TBI)||Device: Active LLLT helmet application Device: Non-active LLLT helmet application||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Low Level Light Therapy (LLLT) With Near Infrared Light Emitting Diodes in Patients With Moderate Traumatic Brain Injury (TBI)|
|Study Start Date :||June 2014|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
Sham Comparator: Non-active LLLT helmet application
A helmet containing near infrared LED's (LLLT helmet) will be applied to the head, however, the LEDs will not be turned on / activated.
Device: Non-active LLLT helmet application
LED helmet applied without light activated
Active Comparator: Active LLLT helmet application
A helmet containing near infrared LEDs (LLLT helmet) will be applied and the LEDs will be turned on/activated
Device: Active LLLT helmet application
LED helmet applied with light activated
- Safety and feasibility of applying light therapy after moderate TBI [ Time Frame: up to seven days after enrollment ]Number of subjects to successfully complete light therapy without serious unanticipated adverse events related to application of the device.
- Neuroreactivity of light therapy to the injured brain based on MRI [ Time Frame: up to 12 months after treatment ]Quantitative MRI metrics.
- Neuroreactivity of light therapy to the injured brain based on neurcognitive function [ Time Frame: up to 12 months after treatment ]Neurocognitive function based on clinical exams.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02233413
|Contact: Rajiv Gupta, MD, PhD||617-726-8354|
|United States, Massachusetts|
|Massachusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Contact: Rajiv Gupta, MD, PhD 617-726-8354|
|Principal Investigator: Rajiv Gupta, MD, PhD|
|Principal Investigator:||Rajiv Gupta, MD, PhD||Massachusetts General Hospital|
|Study Director:||Benjamin Vakoc, PhD||Massachussetts General Hospital|