LED Therapy for the Treatment of Concussive Brain Injury

Description

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 Start Date

September 2012

Estimated Completion Date

May 2016

Interventions

  • Device: MedX Health Console model 1100

Specialties

  • Neurology: Trauma
  • Family Medicine: Complementary Medicine
  • Physician Assistant: Neurology

MeSH Terms

  • Brain Concussion
  • MedX Health Console model 1100

Study ID

Children's Hospital Boston -- IRB-P00002527

Status

Unknown

Trial ID

NCT02383472

Study Type

Interventional

Trial Phase

N/A

Enrollment Quota

48

Sponsor

Children's Hospital Boston

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

Gender

Both

Ages

11 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (2)

Study Location Distance Name Phone Email
Boston Childrens Hospital - Boston, Massachusetts 2.6 miles Nathalie Slick MS 617-355-4636 nathalie.slick@childrens.harvard.edu
Boston Childrens Hospital at Waltham - Waltham, Massachusetts 4.7 miles Michael Pepin MA 781-216-2872 michael.pepin@childrens.harvard.edu

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