External trigeminal nerve stimulation in youth with ADHD: a randomized, sham-controlled, phase 2b trial.
Conti AA, Bozhilova N, Eraydin IE, Stringer D, Johansson L, Marhenke R, Bilbow A, El Masri S, Hyde J, Giaroli G, Liang H, Fiori F, Mehta MA, Santosh P, Carter B, Cortese S, Rubia K
Paper source
External trigeminal nerve stimulation in youth with ADHD: a randomized, sham-controlled, phase 2b trial.
This rigor review was examined and confirmed by Adcurare Editorial · July 7, 2026
How this rating was calculated▸
- IntegrityIntegrity concern−0.5★
- Declared data/code links were not checked for liveness or content.
- Internal contradictions in the reported numbers
This Adcurare Rigor Review uses AI Rigor Reviewers trained on a curated corpus of high-fidelity and retracted papers, with expert supervision and curation. It can still make mistakes; verify each finding against the source before relying on it.
This is a well-conducted and well-reported confirmatory phase 2b RCT of TNS for ADHD. The manuscript is strong across all eight rigor dimensions, with minor gaps in statistical reporting (model assumptions not explicitly verified) and a few copyedit issues (Table 1 percentage error, Table 3 formatting).
Three independent reviewers (all AI) scored all dimensions and fully agreed on pass/fail status for every dimension. Reviewers diverged only on the sub-criterion 'assumptions verified' (R1: reported but inadequate; R2, R3: reported and adequate). The copyedit pass flagged 5 minor issues, mostly in tables. Citation verification found no retracted or unresolved references. Statistics verification successfully recomputed 2 tests with consistent results (coverage limited to tests with full statistics).
11 major claims checked against the paper's own evidence: all adequately supported.
Recomputed 2 tests: 2 consistent, 0 inconsistent, 2 via agent-written checks.
1 integrity concern flagged (0 high).
5 copyedit issues flagged: mostly consistency, clarity, punctuation.
Checked 63 references: 3 verified — 60 not checked.
Registered (1 ID: ISRCTN). Reporting guideline cited: CONSORT.
Ready to submit after minor edits. The two most important fixes are: (1) correct the percentage error in Table 1 for left/mixed handedness (currently 50.6%, should be 25.3%), and (2) add a brief statement verifying the linear mixed model assumptions (e.g., residual plots or a reference justifying robustness). Addressing the other copyedit issues and reviewer suggestions will polish the manuscript for a clean submission.
- 1.HIGHcopyeditCorrect the percentage for 'Left/mixed handed' in the overall column of Table 1: 38 out of 150 participants is 25.3%, not 50.6%. Verify and correct the actual numbers or the percentage.This is a demonstrable arithmetic error that could lead to reviewer scrutiny about data quality.
- 2.HIGHstatisticsAdd a brief statement in the Methods (Statistical analysis) that the assumptions of the linear mixed model (e.g., normality of residuals, homoscedasticity) were checked via residual plots or similar diagnostics, or cite a reference justifying their robustness for the sample size.Explicitly verifying model assumptions strengthens the statistical reporting and preempts reviewer concerns.
- 3.MEDIUMreportingInclude the pre-specified statistical analysis plan (SAP) as a supplementary file or explicitly reference the protocol supplement where it can be found.Improves reproducibility and transparency, as one reviewer suggested.
- 4.MEDIUMreportingIn the Discussion, explicitly note that the positive finding on the MEWS (commission errors) should be considered exploratory due to the lack of correction for multiple comparisons, even if pre-specified.Prevents over-interpretation of a single significant secondary outcome amidst null primary results.
- 5.MEDIUMcopyeditFix the formatting error in Table 3 for the commission errors row: change '0.95 1 (0.80, 1.13)' to '0.95 (0.80, 1.13)' or '0.951 (0.80, 1.13)' as appropriate.The extra space and digit are a typographical error that should be corrected for clarity.
- 6.MEDIUMreportingClarify whether the decision to not analyze teacher-rated secondary outcomes due to high missing data (80%) was a pre-specified criterion or a post-hoc decision, and state this in the Results.Transparency about deviations from the analysis plan is important for integrity.
- 7.MEDIUMreportingAdd exact p-values for all reported secondary outcomes in the text (currently only in Table 3 and for MEWS in text), as suggested by one reviewer.Consistency in reporting p-values improves completeness and reader trust.
- 8.MEDIUMreportingReport the blinding assessment data for the 6-month follow-up if it was collected, to fully characterize blinding integrity over the longer term.Provides a more complete picture of blinding success for the entire trial duration.
- 9.LOWreportingConsider adding a brief note in the Methods on how missing data for the primary outcome were handled in the mixed model (e.g., under missing-at-random assumption).Clarifies the missing data handling approach, which is good practice for clinical trials.
- 10.LOWreportingAdd a reference for the anticipated effect size or the formula used in the sample size calculation.Minor addition to improve completeness of the power analysis justification.
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