LED Therapy for the Treatment of Concussive Brain Injury
Completed · Not applicable · Has a placebo group
Conditions studied: Brain Concussion
In brief
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.
Key facts
- Study ID
- NCT02383472
- Run by
- Boston Children's Hospital
- People needed
- 53
- Starts
- 2012-09-01
- Expected to finish
- 2016-05-01
- Last updated by the study team
- 2018-07-26
Who can join
Age: 11 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Boston Children's Hospital — Boston, Massachusetts, United States
- Boston Children's Hospital at Waltham — Waltham, Massachusetts, United States
Full record on ClinicalTrials.gov
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