Rigor Reviewed

Rigor-Reviewed Manuscript

External trigeminal nerve stimulation in youth with ADHD: a randomized, sham-controlled, phase 2b trial.

Name: Αlpha¹ Rigor Record — External trigeminal nerve stimulation in youth with ADHD: a randomized, sham-controlled, phase 2b trial.
Item: External trigeminal nerve stimulation in youth with ADHD: a randomized, sham-controlled, phase 2b trial.
Rating: 59
Author: Αlpha¹

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

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Αlpha¹ Rigor Review — 2.75★ (Weak), 0 critical, 6 high issues for “External trigeminal nerve stimulation in youth with ADHD: a randomized, sham-controlled, phase 2b trial.”

Links back to this Rigor Record.

Αlpha¹ Editorial

This rigor review was examined and confirmed by Αlpha¹ Editorial · August 10, 2026

Αlpha¹ Rigor Review

Rigor Reviewed

2.75 / 5

Weak — serious problems found

Interventional Study

Critical

High-priority

How this rating was calculated▸

Started at 5★ — deductions

IntegrityIntegrity concern ×3−1.5★
ReportingStatistical analysis not met−0.5★
CitationsUnresolved reference−0.25★

Model-reported confidence: highReviewer agreement: highEngine: 7.29.0Source: full text

Not verified in this report

The numeric-impossibility checks (GRIM/GRIMMER/DEBIT/SPRITE) did not run on this paper: the pass that reads its reported means did not complete. No reported mean was checked for arithmetic impossibility.
No data or code availability links were detected to verify.

Problems surfaced5 types

Numerical inconsistencies1

Values that contradict each other or are impossible for the stated sample: recomputed p-values and test statistics, GRIM/GRIMMER checks on summary numbers, percentages against their own counts, totals against their parts, and estimates against their own confidence intervals.

Internal contradictions in the reported numbersAssessed

Overstated conclusions1

Conclusions that reach past what the paper's own results support — including a significance claim that no longer holds when the statistic is recomputed, and efficacy resting on an unvalidated surrogate endpoint.

Conclusions only partially backed by the presented evidenceAssessed

Reporting gaps1

Required detail the manuscript never states — study design, biological variables, ethics approval and consent, key resources, statistical reporting, data and code availability, and overall transparency.

Statistical reporting inadequateAssessed

Broken references and links1

References checked against Crossref, OpenAlex and Retraction Watch for retractions and resolvability, plus declared data and code links probed for whether they resolve to content matching the paper.

References not resolvable to a published paperRecomputed

Copyediting1

Wording, consistency and formatting errors that need correcting before submission.

Wording or formatting errors that need correctingAssessed

This Αlpha¹ 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.

The paper is a well-designed RCT with strong reporting transparency, but it contains demonstrable arithmetic errors in Table 1 and the Results section that undermine its statistical integrity. The key strengths are the rigorous study design, ethical approvals, and data availability, while the errors warrant a correction and informed reader scrutiny.

This audit evaluated eight dimensions of research integrity using two independent automated reviews and a copyedit pass. All dimensions were applicable. The two reviewers agreed on seven dimensions (pass) but disagreed on statistical analysis; the fail status was adopted based on concrete evidence of arithmetic errors confirmed by the copyedit and integrity checks.

8 major claims checked against the paper's own evidence: all adequately supported.

Recomputed 7 tests: 7 consistent, 0 inconsistent; 7 via agent-written checks.

3 integrity concerns flagged (0 high).

Reporting

Eight Dimensions7 pass · 1 fail

Prior work (McGough 2019 pilot RCT, Westwood meta-analysis) is cited with strengths and weaknesses acknowledged — the pilot was small, restricted to 8–12-year-olds, and its sham condition delivered no stimulation. The rationale links TNS neurobiology (locus coeruleus/noradrenaline) to ADHD deficits, and the hypothesis follows directly. Limitations of prior research are explicitly addressed (multicenter design, adolescent inclusion, 6-month follow-up, improved sham).

Sub-criteria

prior work citedADEQUATE

premise rationaleADEQUATE

limitations addressedADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

The study clearly establishes its scientific foundation, citing the pilot RCT that informed FDA clearance, a prior TNS meta-analysis, and the gaps the trial addresses.

Evidence

paraphrase[Main, paragraph 2]

“The evidence for FDA clearance was based on a pilot double-blind RCT in 62 unmedicated children, showing that 4 weeks of nightly real versus sham TNS significantly decreased parent-rated ADHD symptoms... with medium effect size (Cohen's d = 0.5).”

paraphrase[Main, paragraph 2]

“Furthermore, the pilot study did not assess effects beyond 4 weeks and was limited to very young children aged 8−12 years.”

direct quote[Main, paragraph 2]

“We hypothesized that 4 weeks of nightly real versus sham TNS in children and adolescents with ADHD would improve core symptoms, as measured by parent-rated scales (primary outcome).”