LED Therapy for the Treatment of Concussive Brain Injury
| Status: | Completed |
|---|---|
| Conditions: | Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 11 - Any |
| Updated: | 7/27/2018 |
| Start Date: | September 2012 |
| End Date: | May 2016 |
Transcranial LED Therapy for the Treatment of Chronic Mild Traumatic Brain Injury
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.
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.
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.
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.
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
We found this trial at
2
sites
300 Longwood Ave
Boston, Massachusetts 02115
Boston, Massachusetts 02115
(617) 355-6000
Phone: 617-355-4636
Boston Children's Hospital Boston Children's Hospital is a 395-bed comprehensive center for pediatric health care....
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Waltham, Massachusetts 02453
Principal Investigator: William P Meehan, MD
Phone: 781-216-2872
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