LED Therapy for the Treatment of Concussive Brain Injury
NCT ID: NCT02383472
Last Updated: 2018-07-26
Study Results
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View full resultsBasic Information
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COMPLETED
NA
53 participants
INTERVENTIONAL
2012-09-30
2016-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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.
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
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.
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.
Interventions
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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
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
11 Years
ALL
No
Sponsors
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United States Department of Defense
FED
National Football League
OTHER
Boston Children's Hospital
OTHER
Responsible Party
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William Meehan III
MD, Director of Research - Sports Medicine
Principal Investigators
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William P Meehan, MD
Role: PRINCIPAL_INVESTIGATOR
Boston Children's Hospital
Locations
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Boston Children's Hospital
Boston, Massachusetts, United States
Boston Children's Hospital at Waltham
Waltham, Massachusetts, United States
Countries
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References
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Other Identifiers
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IRB-P00002527
Identifier Type: -
Identifier Source: org_study_id
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