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)

The eTNS4ADHD pilot feasibility trial will test four weeks of active external trigeminal nerve stimulation versus sham in children and adolescents aged 7–17 with ADHD, using intention-to-treat analyses.

• Why it matters: A larger randomized clinical trial is needed, but feasibility metrics—recruitment, compliance, acceptability, follow-up, and concomitant treatment use—must be established first to guide a definitive study.
• What they did: Participants are randomized to active eTNS or sham for four weeks, with feasibility outcomes summarized as proportions with 95% confidence intervals and exploratory ADHD-related outcomes analyzed via regression or non-parametric methods as appropriate.
• The result: Blinded statisticians will produce conclusions before unblinding, and any exploratory clinical findings will be treated as hypothesis-generating to inform feasibility, outcome selection, and future sample size and methods.

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