Clinical trial NCT02383472: LED Therapy for the Treatment of Concussive Brain Injury
Official title: Transcranial LED Therapy for the Treatment of Chronic Mild Traumatic Brain Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Concussion
Keywords: Concussion
Mild Traumatic Brain Injury
MTBI
LED
Light Emitting Diode
Headache
Brain Concussion
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
name: National Football League
First posted: 2015-03-09
Enrollment: 53
Sex: ALL
Minimum age (years): 11
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 description: 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.

Eligibility criteria: Inclusion Criteria:

* Patients 11 years old or greater
* Diagnosed with a concussion whose symptoms have persisted for more than 4 weeks
* Total score on the cognitive components of the post-concussion symptom scale exceeds 9, or if they have a composite score on any one of the 4 main outputs of the computerized neurocognitive assessment: Immediate Post-concussion Assessment and Cognitive Testing (ImPACT) that is below the 90th percentile for their age.

Exclusion Criteria:

* Clinically indicated imaging has been obtained where a hemorrhage is demonstrated
* Being considered for an alternate diagnosis (other than concussion)
* Have a pre-injury diagnosis of any of the following: depression, post-traumatic stress disorder, other psychiatric disorder
* Taking any of the following medications: amantadine, , amphetamine, atomoxetine

Primary outcomes:
measure: Mean Difference in Change in Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) Score at Baseline and 6 Weeks.
timeFrame: From baseline to 6 weeks
Secondary outcomes:
measure: Mean Difference in Change in Delis-Kaplan Executive Function System (D-KEF) Color-Word Interference and Trail Making Test Performance at Weeks 3 and 6.
timeFrame: From baseline to 3 weeks and from baseline to 6 weeks
measure: Mean Difference in Change in Delis-Kaplan Executive Function System (D-KEF) Verbal Fluency Performance at Weeks 3 and 6.
timeFrame: From baseline to 3 weeks and from baseline to 6 weeks
measure: Mean Difference in Change in Total Post Concussion Symptom Score (PCSS) at Weeks 3 and Weeks 6.
timeFrame: From baseline to 3 weeks and from baseline to 6 weeks
measure: Mean Difference in Change in Total Cognitive Symptom Score at Weeks 3 and Weeks 6
timeFrame: From baseline to 3 weeks and from baseline to 6 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
city: Waltham
country: United States
facility: Boston Children's Hospital at Waltham
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: William P Meehan, MD
role: PRINCIPAL_INVESTIGATOR
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