LED Therapy for the Treatment of Concussive Brain Injury
CompletedNot applicableNCT02383472
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Transcranial LED Therapy for the Treatment of Chronic Mild Traumatic Brain Injury
- Conditions
- Brain Concussion
- Interventions
- Device: MedX Health Console model 1100
- Device: MedX Health Console model 1100-placebo
- Sponsor
- Boston Children's Hospital
- Collaborators
- United States Department of Defense; National Football League
- Start date
- 2012-09
- Primary completion
- 2016-05
- Sex
- All
- Age range
- from 11 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- United States
- Total sites listed
- 2
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT02383472