A double-blind, placebo-controlled intervention trial of 3 and 10 mg sublingual melatonin for post-concussion syndrome in youths PLAYGAME: study protocol for a randomized controlled trialReport as inadecuate




A double-blind, placebo-controlled intervention trial of 3 and 10 mg sublingual melatonin for post-concussion syndrome in youths PLAYGAME: study protocol for a randomized controlled trial - Download this document for free, or read online. Document in PDF available to download.

Trials

, 15:271

First Online: 07 July 2014Received: 31 March 2014Accepted: 17 June 2014DOI: 10.1186-1745-6215-15-271

Cite this article as: Barlow, K.M., Brooks, B.L., MacMaster, F.P. et al. Trials 2014 15: 271. doi:10.1186-1745-6215-15-271

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.

KeywordsConcussion Traumatic brain injury Melatonin Placebo Pediatric Randomized controlled trial AbbreviationsACHAlberta Children’s Hospital

ANOVAAnalysis of variance

BASC-2Behavioral assessment system for children

CHEOChildren’s Hospital of Eastern Ontario

CHQChild health questionnaire

CHREBUniversity of Calgary Health Research Ethics Board

DSMBData safety monitoring board

EDEmergency department

mTBIMild traumatic brain injury

PCSPost-concussion syndrome

PCSIPost-concussion symptom inventory

PCSI-PPost-concussion symptom inventory-parent

PCSI-YPost-concussion symptom inventory-youth

PTHPost-traumatic headache

TBITraumatic brain injury

TSCTrial steering committee.

Electronic supplementary materialThe online version of this article doi:10.1186-1745-6215-15-271 contains supplementary material, which is available to authorized users.

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Author: Karen M Barlow - Brian L Brooks - Frank P MacMaster - Adam Kirton - Trevor Seeger - Michael Esser - Susan Crawford - Alb

Source: https://link.springer.com/







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