MedTrace Logo

LED Therapy for the Treatment of Concussive Brain Injury

NCT02383472 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2018-07-26

Study results available
· View outcomes & findings →

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.

Conditions

  • Brain Concussion

Interventions

DEVICE

MedX Health Console model 1100

All treatments will be administered using the MedX Health Console model 1100. These units were cleared by the FDA as non-significant risk in 2003 and approved for home treatment use in 2005 "for temporary increase in local blood flow circulation . . . for temporary relief of minor muscle and joint aches." Cluster heads are 2 inches in diameter. Each contains 9 red (633nm wavelength) diodes and 52 near infrared (870 nm wavelength) diodes. LED cluster heads would be applied to the frontal, parietal and temporal areas, as well as the mid sagittal suture line

DEVICE

MedX Health Console model 1100-placebo

The placebo machine is identical in appearance as the treatment machine; It vibrates, warms, and does everything the treatment machine does except it does not have LED lights on the marker, therefore it cannot emit light. Subjects enrolled in the placebo group will be on the same schedule as the treatment group. They will have two, 10 minute treatments, three times a week totaling 18 visits. The placebo allows the researchers to isolate the effect of the study treatment. If patient's in the LED treatment group fare significantly better than those in the placebo treatment group, the study helps support the conclusion that the LED therapy is effective.

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • National Football League

    collaborator OTHER

  • Boston Children's Hospital

    lead OTHER

Principal Investigators

  • William P Meehan, MD · Boston Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
11 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2016-05-31
Completion
2016-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02383472 on ClinicalTrials.gov