N/A
N=53
LED Therapy for the Treatment of Concussive Brain Injury
Brain Concussion
Bottom Line
View on ClinicalTrials.gov: NCT02383472 ↗Enrolled (actual)
53
Serious AEs
0.0%
Results posted
Jun 2018
Primary outcome: Primary: Mean Difference in Change in Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) Score at Baseline and 6 Weeks. — -0.9; -5.78; 3.52; -7.26 Units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- MedX Health Console model 1100 (Device); MedX Health Console model 1100-placebo (Device)
- Age
- Pediatric, Adult, Older Adult · 11+ yrs
- Sex
- All
- Sponsor
- Boston Children's Hospital
- Primary completion
- May 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Difference in Change in Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) Score at Baseline and 6 Weeks. |
-0.9; -5.78; 3.52; -7.26; -2.04; -5.15 | — |
| SECONDARY 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. |
3.27; 4.76; 3.76; 4.07; 0.95; 4.07 | — |
| SECONDARY Mean Difference in Change in Delis-Kaplan Executive Function System (D-KEF) Verbal Fluency Performance at Weeks 3 and 6. |
-3.45; -6.10; -6.71; -9.89; -1.14; -0.03 | — |
| SECONDARY Mean Difference in Change in Total Post Concussion Symptom Score (PCSS) at Weeks 3 and Weeks 6. |
9.41; 7.03; 7.86; 14.63 | — |
| SECONDARY Mean Difference in Change in Total Cognitive Symptom Score at Weeks 3 and Weeks 6 |
3.95; 1.31; 4.00; 5.00 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT02383472). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.