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LED Therapy for the Treatment of Concussive Brain Injury

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ClinicalTrials.gov Identifier: NCT02383472
Recruitment Status : Completed
First Posted : March 9, 2015
Results First Posted : June 29, 2018
Last Update Posted : July 26, 2018
Sponsor:
Collaborators:
United States Department of Defense
National Football League
Information provided by (Responsible Party):
William Meehan III, Boston Children's Hospital

Tracking Information
First Submitted Date  ICMJE March 4, 2015
First Posted Date  ICMJE March 9, 2015
Results First Submitted Date  ICMJE March 21, 2018
Results First Posted Date  ICMJE June 29, 2018
Last Update Posted Date July 26, 2018
Study Start Date  ICMJE September 2012
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 31, 2018)		 Mean Difference in Change in Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) Score at Baseline and 6 Weeks. [ Time Frame: From baseline to 6 weeks ]
The primary outcome is mean difference on composite scores of Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) between entry into the study and completion of treatment (visit 18, week 6) for both the LED group and the placebo group. The mean difference is calculated by taking the mean of differences of the entry scores minus the 6 week scores. There are 5 composite scores on the ImPACT test; verbal memory, visual memory, visual motor speed, reaction time, and symptom score. The ranges for these subscales are as follows: verbal memory and visual memory: 0-100, visual motor speed: 0-60, reaction time: 0-1.0, and symptom score: 0-132. A higher verbal memory, visual memory, and visual motor speed represent a better outcome, while a lower reaction time and lower symptom score represent a better outcome.
Original Primary Outcome Measures  ICMJE
 (submitted: March 4, 2015)		 ImPACT Score mean difference [ Time Frame: 6 weeks ]
The primary outcome is mean difference on composite scores of ImPACT between entry into the study and final test at week 6.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 31, 2018)
  • 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. [ Time Frame: From baseline to 3 weeks and from baseline to 6 weeks ]
    This measure indicates the mean differences in Delis-Kaplan Executive Function System (D-KEF) tests between entry into the study and 3 weeks and entry into the study and 6 weeks for both the LED group and the placebo group. The mean difference is calculated by taking the mean of differences of the entry scores minus the 3 week scores and the entry scores minus the 6 week scores. D-KEFs color-word interferences, made up of color naming, word reading, and inhibition, is measured in seconds, a smaller number represents a better outcome. Participants were given 90 seconds to complete color naming and word reading and 180 seconds to complete inhibition. D-KEFs trail making test, made up of number sequencing, letter sequencing, and number-letter sequencing, is measured in seconds, a faster speed (lower number) represents a better outcome. Participants were given 150 seconds to complete number and letter sequencing and 240 seconds to complete number-letter sequencing.
  • Mean Difference in Change in Delis-Kaplan Executive Function System (D-KEF) Verbal Fluency Performance at Weeks 3 and 6. [ Time Frame: From baseline to 3 weeks and from baseline to 6 weeks ]
    This measure indicates the mean differences in Delis-Kaplan Executive Function System (D-KEF) tests between entry into the study and 3 weeks and entry into the study and 6 weeks for both the LED group and the placebo group. The mean difference is calculated by taking the mean of differences of the entry scores minus the 3 week scores and the entry scores minus the 6 week scores. D-KEFs Verbal Fluency Test, made up of letter fluency and category fluency, is measured by number of responses, a larger number represents a better outcome. Participants were given 60 seconds to complete each fluency test.
  • Mean Difference in Change in Total Post Concussion Symptom Score (PCSS) at Weeks 3 and Weeks 6. [ Time Frame: From baseline to 3 weeks and from baseline to 6 weeks ]
    This measure indicates the mean differences in total post concussion symptom score (PCSS) between entry into the study and 3 weeks and entry into the study and 6 weeks for both the LED group and the placebo group. The mean difference is calculated by taking the mean of differences of the entry scores minus the 3 week scores and the entry scores minus the 6 week scores. The PCSS is a sum of severity scores from 0-6 (0=none, 6=severe) for 22 individual symptoms, like headache, neck pain, or drowsiness. The range for the PCSS is 0-132, a lower score represents a better outcome.
  • Mean Difference in Change in Total Cognitive Symptom Score at Weeks 3 and Weeks 6 [ Time Frame: From baseline to 3 weeks and from baseline to 6 weeks ]
    This measure indicates the mean difference in total cognitive symptom scores between entry into the study and 3 weeks and entry into the study and 6 weeks for both the LED group and the placebo group. The mean difference is calculated by taking the mean of differences of the entry scores minus the 3 week scores and the entry scores minus the 6 weeks scores. The total cognitive symptom scored is a sum of 7 symptom scores from the PCSS; feeling slowed down, feeling like "in a fog", "don't feel right", difficulty concentrating, difficulty remembering, fatigue or low energy, and confusion. The severity of these symptoms are scored 0-6, 0=none, 6=severe. The range for the total cognitive symptom score is 0-42, a lower score represents a better outcome.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 4, 2015)		 Means total post concussion symptom scale score [ Time Frame: 3 to 6 weeks ]
Finding mean difference in total post concussion symptom scale score at weeks 3 and 6.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures
 (submitted: March 4, 2015)
  • Total Cognitive Score [ Time Frame: 3 to 6 weeks ]
    Finding mean differences in total score on the cognitive components of the post concussion symptom scale.
  • Total Post Concussion Symptom Score [ Time Frame: 3 to 6 weeks ]
    Finding mean differences in total post concussion symptom scale score.
  • ImPACT paradigms [ Time Frame: 3 to 6 weeks ]
    Finding mean difference in raw scores of the individual ImPACT paradigms.
  • D-KEFS [ Time Frame: 3 to 6 weeks ]
    Finding mean differences in performance on the D-KEFS.
 
Descriptive Information
Brief Title  ICMJE LED Therapy for the Treatment of Concussive Brain Injury
Official Title  ICMJE Transcranial LED Therapy for the Treatment of Chronic Mild Traumatic Brain Injury
Brief 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.
Detailed Description

Concussion, also known as mild traumatic brain injury (mTBI), results from a rotational acceleration of the brain. The biomechanical forces which cause concussion lead to the opening of ion channels within the neuronal cell membranes, allowing for a massive influx of sodium and efflux of potassium. This results in a spreading depression type of phenomenon, leading to the depolarization of neurons diffusely throughout the brain.19 In order to restore the homeostatic ion gradients across the membrane, the sodium-potassium pumps require increasing amounts of adenosine triphosphate (ATP). Thus, there is an increased need for ATP after concussion. ATP is supplied by the glycolysis of glucose from the blood stream. Both experimental models of concussion and human studies, however, show decreased cerebral blood flow after the initial response to injury. Thus, there is an increased demand for ATP after concussion; but a diminished supply of glucose to meet the demand.

The absorption of light in the red/near infrared wavelength spectrum by cytochrome C oxidase increases ATP synthesis. Thus, by increasing ATP synthesis, red/near infrared LEDs can treat the underlying pathophysiological cause of concussion symptoms. If successful, this would be the first therapy to directly treat the underlying pathophysiology of concussion.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Brain Concussion
Intervention  ICMJE
  • 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
    Other Names:
    • MedX LCT 100 & Duolight
    • Manufacturer-MedX Health Inc.
  • 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.
    Other Names:
    • MedX LCT 100 & Duolight
    • Manufacturer-MedX Health Inc.
Study Arms  ICMJE
  • Experimental: MedX Health Console model 1100
    The treatment group will receive LED treatments over 6 weeks, 3 times per week, totaling 18 visits. All treatments will take place at Boston Children's Hospital. The cluster heads are applied to frontal, parietal, and temporal areas. Each cluster head is applied to the forehead/scalp areas for up to 10 minutes. There will be two 10-minute LED/placebo treatment periods per visit, each with different cluster head placements on the head/scalp.
    Intervention: Device: MedX Health Console model 1100
  • Placebo Comparator: MedX Health Console model 1100-placebo
    Subjects enrolled in the placebo group will be on the same schedule as the treatment group. The placebo group will receive LED placebo over 6 weeks, 3 times per week, totaling 18 visits. All placebo patients will take place at Boston Children's Hospital. The cluster heads are applied to frontal, parietal, and temporal areas. Each cluster head is applied to the forehead/scalp areas for up to 10 minutes. There will be two 10-minute LED/placebo treatment periods per visit, each with different cluster head placements on the head/scalp.
    Intervention: Device: MedX Health Console model 1100-placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 31, 2018)		 53
Original Estimated Enrollment  ICMJE
 (submitted: March 4, 2015)		 40
Actual Study Completion Date  ICMJE May 2016
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 11 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02383472
Other Study ID Numbers  ICMJE IRB-P00002527
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party William Meehan III, Boston Children's Hospital
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Boston Children's Hospital
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • United States Department of Defense
  • National Football League
Investigators  ICMJE
Principal Investigator: William P Meehan, MD Boston Children's Hospital
PRS Account Boston Children's Hospital
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP