Abstract
BackgroundBy the age of sixteen, one in five children will sustain a mild traumatic brain injury also known as concussion. Our research found that one in seven school children with mild traumatic brain injury suffer post-concussion syndrome symptoms for three months or longer. Post-concussion syndrome is associated with significant disability in the child and his/her family and yet there are no evidence-based medical treatments available. Melatonin has several potential mechanisms of action that could be useful following mild traumatic brain injury, including neuroprotective effects. The aim of this study is to determine if treatment with melatonin improves post-concussion syndrome in youths following mild traumatic brain injury. Our hypothesis is that treatment of post-concussion syndrome following mild traumatic brain injury with 3 or 10 mg of sublingual melatonin for 28 days will result in a decrease in post-concussion syndrome symptoms compared with placebo.Methods/DesignNinety-nine youths with mild traumatic brain injury, aged between 13 and 18 years, who are symptomatic at 30 days post-injury will be recruited. This study will be conducted as a randomized, double blind, placebo-controlled superiority trial of melatonin. Three parallel treatment groups will be examined with a 1:1:1 allocation: sublingual melatonin 3 mg, sublingual melatonin 10 mg, and sublingual placebo. Participants will receive treatment for 28 days. The primary outcome is a change on the Post-Concussion Symptom Inventory (Parent and Youth). The secondary outcomes will include neurobehavioral function, health-related quality of life and sleep. Neurophysiological and structural markers of change, using magnetic resonance imaging techniques and transcranial magnetic stimulation, will also be investigated.DiscussionMelatonin is a safe and well-tolerated agent that has many biological properties that may be useful following a traumatic brain injury. This study will determine whether it is a useful treatment for children with post-concussion syndrome. Recruitment commenced on 4 December 2014.Trial registrationThis trial was registered on 6 June 2013 at ClinicalTrials.gov. Registration number: NCT01874847.
Highlights
By the age of sixteen, one in five children will sustain a mild traumatic brain injury known as concussion
This study will determine whether it is a useful treatment for children with post-concussion syndrome
Pilot data using melatonin in post-concussion syndrome (PCS) We found that children with prolonged PCS and headaches had a significant response to melatonin treatment [61,121]
Summary
By the age of sixteen, one in five children will sustain a mild traumatic brain injury known as concussion. Mild traumatic brain injury (mTBI) is the acute neurophysiological effect of blunt impact or other mechanical energy applied to the head, such as from sudden acceleration, deceleration or rotational forces [5,6] It accounts for 90% of all TBIs [7]. It has been shown that 2% of mTBI children continue to have PCS symptoms one year later [10] Using these figures, we estimate that annually over a 1000 children in Canada have PCS for over a year due to a ‘mild’ TBI and yet there are no evidence-based medical treatments available [18]. Our neurobiological understanding of PCS is lacking [6,18], and routine clinical tests are not informative and so are not helpful in guiding treatment
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