Statistical analysis plan for the feasibility trial assessing external trigeminal nerve stimulation versus sham stimulation for ADHD in children and adolescents aged 7 to 17 years (the eTNS4ADHD trial)

Abstract Background: External trigeminal nerve stimulation (eTNS) is a non-invasive intervention being investigated as a potential treatment for attention-deficit/hyperactivity disorder (ADHD) in children and adolescents. The eTNS4ADHD trial aims to assess the feasibility of conducting a larger randomised clinical trial comparing active eTNS with sham stimulation. This paper presents the prespecified statistical analysis plan for the trial. Methods: The eTNS4ADHD trial is a multicentre, parallel-group, randomised pilot and feasibility trial involving children and adolescents aged 7 to 17 years

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