Clinical Trial: LED Therapy for the Treatment of Concussive Brain Injury

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Transcranial LED Therapy for the Treatment of Chronic Mild Traumatic Brain Injury

Brief Summary: A double blind randomized trial of light-emitting diode (LED) therapy for patients suffering from mild traumatic brain injury (mTBI). Patients seen in the Sports Concussion Clinic with cognitive symptoms lasting for greater than 4 weeks will be randomized to either placebo therapy (controls) or treatment with LED therapy (cases). Both cases and controls would complete post-concussion symptom scales Delis-Kaplan Executive Function System (D-KEFS), and ImPACT studies on entry into the study and at weeks 3 and 6, or earlier if their symptoms resolve before the end of the 6 week period.

Detailed Summary:

Concussion, also known as mild traumatic brain injury (mTBI), results from a rotational acceleration of the brain. The biomechanical forces which cause concussion lead to the opening of ion channels within the neuronal cell membranes, allowing for a massive influx of sodium and efflux of potassium. This results in a spreading depression type of phenomenon, leading to the depolarization of neurons diffusely throughout the brain.19 In order to restore the homeostatic ion gradients across the membrane, the sodium-potassium pumps require increasing amounts of adenosine triphosphate (ATP). Thus, there is an increased need for ATP after concussion. ATP is supplied by the glycolysis of glucose from the blood stream. Both experimental models of concussion and human studies, however, show decreased cerebral blood flow after the initial response to injury. Thus, there is an increased demand for ATP after concussion; but a diminished supply of glucose to meet the demand.

The absorption of light in the red/near infrared wavelength spectrum by cytochrome C oxidase increases ATP synthesis. Thus, by increasing ATP synthesis, red/near infrared LEDs can treat the underlying pathophysiological cause of concussion symptoms. If successful, this would be the first therapy to directly treat the underlying pathophysiology of concussion.


Sponsor: Boston Children’s Hospital

Current Primary Outcome: ImPACT Score mean difference [ Time Frame: 6 weeks ]

The primary outcome is mean difference on composite scores of ImPACT between entry into the study and final test at week 6.


Original Primary Outcome: Same as current

Current Secondary Outcome: Means total post concussion symptom scale score [ Time Frame: 3 to 6 weeks ]

Finding mean difference in total post concussion symptom scale score at weeks 3 and 6.


Original Secondary Outcome: Same as current

Information By: Boston Children’s Hospital

Dates:
Date Received: March 4, 2015
Date Started: September 2012
Date Completion:
Last Updated: August 22, 2016
Last Verified: August 2016