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

Table 2 Inclusion and exclusion criteria

Inclusion criteria	Exclusion criteria
Age 13-18 years inclusive	Previous significant medical history
Mild traumatic brain injury [139]	Previous concussion within 12 months
Symptomatic (increase in PCS symptoms compared with pre-injury) at 30 days post injury	Lactose intolerance, as the placebo contains lactose
	Use of drugs that are likely to affect TMS, fMRI and/or sleep
	Inability to complete questionnaires or evaluation
	Claustrophobia or inability to tolerate MRI
	Contraindications to TMS (including history of seizures, unexplained loss of consciousness, metal in the head and/or implanted brain medical devices, cardiac pacemaker, and so on)

Post Concussion Syndrome (PCS), Transcranial Magnetic Stimulation (TMS), Magnetic Resonance Imaging (MRI), functional MRI (fMRI).

ISSN: 1745-6215