Kaimen Rigor reviewed

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

Name: Kaimen Rigor review — 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: 100
Author: Alpha1

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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Kaimen Rigor review — 3.25★ (Adequate), 0 critical, 3 high issues for “External trigeminal nerve stimulation in youth with ADHD: a randomized, sham-controlled, phase 2b trial.”

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Alpha1 Editorial

This rigor review was examined and confirmed by Alpha1 Editorial · August 15, 2026

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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

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DOI

10.1038/s41591-025-04075-x

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Kaimen Rigor reviewed

Rigor-Reviewed Manuscript

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.

Read full text (PMC)

Embed this Rigor badge

Links back to this Kaimen Rigor review.

Alpha1 Editorial

This rigor review was examined and confirmed by Alpha1 Editorial · August 15, 2026

Kaimen Rigor review

Kaimen Rigor reviewed

3.25 / 5

Adequate — real issues to address

Interventional Study

Critical

High-priority

How this rating was calculated▸

Started at 5★ — deductions

IntegrityIntegrity concern ×2−1★
ClaimsOverstated claim−0.5★
CitationsUnresolved reference−0.25★

Model-reported confidence: highReviewer agreement: highEngine: 7.39.0Source: full text

Not verified in this report

Declared data/code links were not checked for liveness or content.

Biggest issues

01Conclusion reaches beyond the evidence
mediumOverreachreviewer-assessedFull detail
The MEWS improvement may represent a clinically meaningful benefit.
“this may represent a clinically meaningful benefit of the treatment.”
Discussion ¶5Find in source

Findings by category

101ArithmeticNumerical inconsistencies 202OverreachOverstated conclusions 03AuthenticityNone found 04DisclosureNone found 105AvailabilityBroken references and links · partly checked 06Copyedit4 minor suggestions

This Kaimen Rigor review uses Kaimen 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 randomized sham-controlled trial. The methods are rigorous, ethical approvals are documented, and data are publicly available. Minor reporting inconsistencies and an overstated claim in the discussion are the main weaknesses.

Both reviewers independently scored all dimensions as pass with high confidence; no divergence. The study is an interventional RCT; non-applicable criteria (e.g., animal housing, cell lines) were excluded. Statistics verification covered only 2 tests; other reported statistics were not machine-verified.

Numerical inconsistencies

1 finding · worst low

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

Recomputed 2 tests: 2 consistent, 0 inconsistent; 2 via agent-written checks.

Overstated conclusions

2 findings · worst medium

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 overstated beyond the evidenceAssessed
Conclusions only partially backed by the presented evidenceAssessed

5 major claims checked against the paper's own evidence: 1 not fully backed by the presented evidence (unsupported or overstated), 1 only partially supported (evidence backs part of the claim; gaps or caveats remain).

Data authenticity concerns

None found

An adversarial read for patterns associated with data that may not be genuine: results that look too clean, implausibly large effects, duplicated data or images, and methods that do not match the results reported.

Checked — nothing surfaced.

Reporting gaps

None found

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.

Checked — nothing surfaced.

Eight Dimensions8 pass

The introduction cites the pilot RCT (McGough et al.) and a meta-analysis of TNS safety, and explains the need for a definitive multicenter trial. It also addresses limitations of prior work, such as the pilot's short duration and narrow age range, and describes how the current study addresses these gaps. The hypothesis follows logically from the cited evidence.

Sub-criteria

prior work citedADEQUATE

premise rationaleADEQUATE

limitations addressedADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The paper establishes a clear scientific premise by citing prior research, including the pilot RCT that led to FDA clearance, and provides a logical rationale for the confirmatory trial.

Evidence

paraphrase[Introduction, paragraph 3]

“Our recent meta-analysis showed that TNS is safe with good tolerability for neurological and psychiatric conditions.”

paraphrase[Introduction, paragraph 4]

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

“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).”

Introduction ¶4Find in source

PASSReviewer 2· 90% conf

The paper establishes a clear scientific premise by citing prior research, including the pilot RCT that led to FDA clearance, and provides a logical rationale for the confirmatory trial.

Evidence

paraphrase[Introduction, paragraph 3]

“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 on the ADHD Rating Scale (ADHD-RS), with medium effect size (Cohen’s d = 0.5).”

paraphrase[Introduction, paragraph 4]

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

Randomization was done by minimization with a validated web-based system, and blinding was comprehensive (participants, parents, researchers, and analysts). A priori sample size calculation is provided. Inclusion/exclusion criteria are detailed. The analysis population (ITT) and handling of missing data (CACE analysis) are described. The trial is a human RCT, so replicate_distinction, controls, and independent_replication are not applicable.

Sub-criteria

controlsN/A

power analysisADEQUATE

blinding levelsADEQUATE

outlier handlingADEQUATE

randomization unitADEQUATE

inclusion exclusionADEQUATE

randomization methodADEQUATE

replicate distinctionN/A

independent replicationN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

The trial design is rigorous: randomization method, blinding, sample size justification, inclusion/exclusion criteria, and analysis population are all adequately described.

Evidence

paraphrase[Methods, Randomization and blinding]

“Randomization was done by minimization by sex (male/female), medication status (on medication, off medication/naive), site (London, Southampton) and age (8–13.5 years, 13.6−19 years) using a validated, online, web-based system from King’s Clinical Trials unit.”

“Participants, parents/carers, postdoctoral research associates, principal investigator, co-investigators and analysts were blinded to treatment group except for the trial manager (L.J.) and trial manager assistants (S.E.M. and J.H.)”

MethodsFind in source

paraphrase[Methods, Sample size justification]

“The estimated sample size of 128 participants (64:64) was calculated using a baseline to posttreatment correlation of 0.5, 90% power, 5% type I error and an anticipated effect size of 0.5 for a reduction in ADHD symptoms at 4 weeks.”

PASSReviewer 2· 95% conf

The trial design is rigorous: randomized, double-blind, sham-controlled, with a prespecified statistical analysis plan, sample size justification, and clear inclusion/exclusion criteria.

Evidence

paraphrase[Methods, Randomization and blinding]

MethodsFind in source

paraphrase[Methods, Sample size justification]

Sex at birth is reported for all participants, and both sexes are included, so sex_justified is not applicable. Age, weight, and health status are reported. Demographics include ethnicity, handedness, and deprivation index. Species/strain and housing conditions are not applicable for a human trial.

Sub-criteria

demographicsADEQUATE

sex reportedADEQUATE

sex justifiedN/A

age weight healthADEQUATE

housing conditionsN/A

species strain sourceN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

Biological variables are well reported: sex, age, health status, and demographics are all described in detail.

Evidence

“150 (97 males, 64.7%) were enrolled in the study”

ResultsFind in source

“Participants had a mean age (s.d.) of 12.6 years (2.8)”

ResultsFind in source

paraphrase[Table 1]

“Child ethnicity | White | 61 (81.3) | 58 (77.3) | 119 (79.3)”

PASSReviewer 2· 90% conf

Demographic and clinical characteristics are well reported, including sex, age, ethnicity, and medication status.

Evidence

paraphrase[Table 1]

“Child sex at birth | Male | 49 (65.3) | 48 (64.0) | 97 (64.7)”

“White | 61 (81.3) | 58 (77.3) | 119 (79.3)”

Table 1Find in source

The trial was approved by the West Midlands–Solihull NHS Research Ethics Committee (with reference numbers) and the MHRA. Informed consent/assent is described. Compliance with the Declaration of Helsinki is stated. All applicable criteria are met.

Sub-criteria

iacuc statementN/A

informed consentADEQUATE

irb ethics statementADEQUATE

regulatory complianceADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

Ethical approvals are fully documented: named ethics committee, regulatory approval, informed consent, and compliance with the Declaration of Helsinki.

Evidence

“The trial was approved by the West Midlands–Solihull NHS Research Ethics Committee (REC; Ref21:/WN/0169; IRAS: 299703) and the Medicines and Healthcare products Regulatory Agency (MHRA; Ref: CI/2022/0003/GB).”

MethodsFind in source

“Children/adolescents and their parents/carers provided both digital and written informed consents/assents”

MethodsFind in source

“It was conducted in accordance with the 1975 Declaration of Helsinki”

MethodsFind in source

PASSReviewer 2· 95% conf

Ethical approval and consent are clearly documented with named bodies and protocol numbers.

Evidence

MethodsFind in source

“Children/adolescents and their parents/carers provided both digital and written informed consents/assents”

MethodsFind in source

The device is named with manufacturer (NeuroSigma, Inc.) and full stimulation parameters are given. Statistical software (Stata 18) and data capture system (MACRO) are identified. No antibodies, cell lines, or organisms are used, so those are not applicable.

Sub-criteria

mycoplasma testingN/A

reagents identifiedADEQUATE

organisms identifiedN/A

antibodies identifiedN/A

cell line authenticationN/A

software tools identifiedADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The investigational device (Monarch TNS System) is identified with manufacturer and detailed settings; software tools are identified with versions.

Evidence

“Real and sham TNS was performed with the Monarch TNS System (NeuroSigma, Inc.).”

MethodsFind in source

“Analyses were performed in Stata 18 (StataCorp LLC, version 18.0)”

Statistical analysisFind in source

“Study data were entered and managed using the MACRO Electronic Data Capture system (version 4.15.0.116).”

MethodsFind in source

PASSReviewer 2· 90% conf

The investigational device (Monarch TNS System) is identified with manufacturer and detailed settings; software tools are named with versions.

Evidence

“Real and sham TNS was performed with the Monarch TNS System (NeuroSigma, Inc.).”

MethodsFind in source

“Analyses were performed in Stata 18 (StataCorp LLC, version 18.0)”

Statistical analysisFind in source

Tests are named (linear mixed models, MMRM, CACE). Assumptions are handled by design (mixed models). Exact p-values are reported for primary and secondary outcomes. Effect sizes with CIs are reported. Software is identified. Data presentation includes per-group n and CIs. Mathematical plausibility checks were not applicable for most continuous outcomes, but no inconsistencies were found.

Sub-criteria

tests namedADEQUATE

exact p valuesADEQUATE

effect sizes ciADEQUATE

data presentationADEQUATE

software identifiedADEQUATE

assumptions verifiedADEQUATE

mathematical plausibilityN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

Statistical methods are appropriate and well described; effect sizes with confidence intervals are reported; no arithmetic errors detected.

Evidence

“For the primary analysis, a longitudinal linear mixed model was used”

Statistical analysisFind in source

paraphrase[Results, Primary outcome]

“P = 0.622”

“Cohen’s d = 0.09”

ResultsFind in source

PASSReviewer 2· 90% conf

Statistical methods are appropriate and well described, with exact p-values and effect sizes with confidence intervals.

Evidence

“estimated adjusted mean difference (aMD) = 0.83; 95% confidence interval: –2.47 to 4.13; P = 0.622; Cohen’s d = 0.09”

ResultsFind in source

“P values were calculated using two-sided z -tests from the linear mixed models as outlined in methods.”

Table 2Find in source

The data availability statement names a concrete repository (figshare) with a DOI. Since no custom code was generated, code_sharing is not applicable. Repository deposit and accession numbers are satisfied by the figshare DOI.

Sub-criteria

code sharingN/A

accession numbersADEQUATE

repository depositADEQUATE

data availability statementADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

Data are deposited in a public repository with a DOI; no custom code was used.

Evidence

“All data supporting the findings of this study have been deposited in the figshare repository and are publicly available at 10.6084/m9.figshare.29414744.v1.”

Data availabilityFind in source

“No custom code was generated or used in this study.”

Data availabilityFind in source

PASSReviewer 2· 95% conf

Data are deposited in a public repository with a DOI, and a clear data availability statement is provided.

Evidence

“All data supporting the findings of this study have been deposited in the figshare repository and are publicly available at 10.6084/m9.figshare.29414744.v1.”

Data availabilityFind in source

Trial registration number is provided. CONSORT guidelines are referenced. All pre-specified outcomes are reported, including negative results. Limitations are explicitly discussed. Conclusions are proportional to the evidence. Funding sources and competing interests are stated.

Sub-criteria

funding coiADEQUATE

trial registrationADEQUATE

reporting guidelineADEQUATE

methods completenessADEQUATE

all outcomes reportedADEQUATE

limitations discussedADEQUATE

conclusions proportionalADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

The trial is registered, reported per CONSORT, all outcomes are reported, limitations are discussed, and funding/COI are disclosed.

Evidence

“Trial registration: ISRCTN82129325”

AbstractFind in source

paraphrase[Methods, Trial design]

“It is reported following CONSORT guidelines”

“Limitations include a high rate of missing data on teacher ratings (80%) due to low teacher participation.”

Discussion ¶7Find in source

PASSReviewer 2· 95% conf

The trial is registered, reported per CONSORT, and includes funding and COI statements; limitations are discussed.

Evidence

“Trial registration: ISRCTN82129325 (http://www.isrctn.com/ISRCTN82129325)”

AbstractFind in source

paraphrase[Methods, Trial design]

“It was conducted in accordance with the 1975 Declaration of Helsinki and is reported following CONSORT guidelines.”

“Limitations include a high rate of missing data on teacher ratings (80%) due to low teacher participation.”

Discussion ¶8Find in source

Registered (1 ID: ISRCTN). Reporting guideline cited: CONSORT.

Broken references and links

1 finding · worst low

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

Checked 63 references by DOI: 3 verified — 1 DOI unresolved, 59 no DOI (shown, not verified).

Copyediting

4 minor

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

No major wording or formatting errors. 4 minor suggestions below.

4 copyedit issues flagged: mostly consistency, typo.

Kaimen Rigor Action ItemsFinal pass before journal submission

The published work is robust and well-reported. An informed reader should weigh the minor reporting inconsistencies (handedness percentage, age criterion) and the overstated MEWS claim, which may warrant a correction or clarification. No major validity threats identified.

1.
HIGHreporting
Temper the claim that the MEWS improvement may represent a clinically meaningful benefit in the Discussion, noting it was not replicated in older adolescents and could be a type I error.
The claim audit rated this as overstated; the paper's own text acknowledges the limitation.
2.
HIGHreporting
Clarify in the Results (Participant disposition) whether the four participants who turned 19 before randomization were included despite exceeding the stated age criterion, and reconcile with the inclusion criteria.
The copyedit and integrity checks flagged a potential internal contradiction with the 8-18 year inclusion criterion.
3.
HIGHreporting
Correct the handedness row in Table 1: the real TNS group percentage should be 20.0% (not 20) and the overall percentage should sum to 100% with the right-handed percentage.
The copyedit and integrity checks flagged an arithmetic inconsistency in the handedness percentages.
4.
MEDIUMreporting
Add a note in the Discussion about the potential for type I error due to multiple testing, particularly for the MEWS finding.
Reviewer 2 suggested this to improve interpretation of secondary outcomes.
5.
MEDIUMreporting
Report the exact p-values for all secondary outcomes in the tables instead of threshold-only values.
Both reviewers noted some secondary outcomes are reported as thresholds, reducing precision.
6.
MEDIUMreporting
Provide the full statistical analysis plan as a supplementary file or appendix.
Both reviewers suggested this to enhance transparency and allow independent replication.
7.
MEDIUMreporting
Include a CONSORT flow diagram in the main text (or ensure Fig. 1 is clearly labeled as such) and report the number of participants completing the 6-month follow-up.
Reviewer 2 noted the flow diagram is referenced but not explicitly included; clarifying attrition improves reporting completeness.
8.
MEDIUMdata code
Provide a data dictionary or codebook for the deposited figshare data to facilitate reuse.
Both reviewers suggested this to improve data usability.
9.
MEDIUMreporting
Add a statement in the Limitations about the generalizability of findings to non-UK settings.
Reviewer 2 suggested this to address external validity.
10.
LOWcopyedit
Fix the extra space in Table 3, Mackworth Vigilance Task commission errors row ("0.95 1" should be "0.95").
Minor typo flagged by copyedit.
11.
LOWcopyedit
Use consistent terminology ("participants" instead of "children") in the Results section.
Copyedit flagged inconsistent terminology.
12.
LOWreporting
Report the results of the CACE analysis in the main text rather than only in extended data.
Reviewer 1 suggested this to improve accessibility of sensitivity analyses.
13.
LOWreporting
Report the results of post hoc subgroup analyses in the main text or clearly label them as exploratory.
Reviewer 1 suggested this to avoid over-interpretation.
14.
LOWreporting
Report the intraclass correlation coefficient or variance components from the mixed models.
Both reviewers suggested this to aid power calculations for future trials.

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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

Read full text (PMC)

DOI

10.1038/s41591-025-04075-x

Share this Kaimen Rigor review

Post on X Share on LinkedIn Share via Email

Embed this Rigor badge

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  <img src="https://alpha1science.com/verify/9a93922a-d3ea-4ac5-85c1-1f8e05b4e52b/badge" alt="Kaimen Rigor review — 3.25★ (Adequate), 0 critical, 3 high issues for “External trigeminal nerve stimulation in youth with ADHD: a randomized, sham-controlled, phase 2b trial.”" width="440" height="104" style="max-width:100%;height:auto" />
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Record fingerprint

bdf724ffc3534b99de1538678069c3bef67ce014490b51ee74eda23d8e8c324f

Verify via API

Issued Aug 15, 2026Engine 7.39.0

Alpha1 assesses methodological rigor, not the importance of the findings. See how we calibrate →

Kaimen Rigor review

Kaimen Rigor reviewed

3.25 / 5

Adequate — real issues to address

Interventional Study

Critical

High-priority

How this rating was calculated▸

Started at 5★ — deductions

IntegrityIntegrity concern ×2−1★
ClaimsOverstated claim−0.5★
CitationsUnresolved reference−0.25★

Model-reported confidence: highReviewer agreement: highEngine: 7.39.0Source: full text

Not verified in this report

Declared data/code links were not checked for liveness or content.

Biggest issues

01Conclusion reaches beyond the evidence
mediumOverreachreviewer-assessedFull detail
The MEWS improvement may represent a clinically meaningful benefit.
“this may represent a clinically meaningful benefit of the treatment.”
Discussion ¶5Find in source

Findings by category

Numerical inconsistencies

1 finding · worst low

Internal contradictions in the reported numbersAssessed

Recomputed 2 tests: 2 consistent, 0 inconsistent; 2 via agent-written checks.

Overstated conclusions

2 findings · worst medium

Conclusions overstated beyond the evidenceAssessed
Conclusions only partially backed by the presented evidenceAssessed

Data authenticity concerns

None found

Checked — nothing surfaced.

Reporting gaps

None found

Checked — nothing surfaced.

Eight Dimensions8 pass

Sub-criteria

prior work citedADEQUATE

premise rationaleADEQUATE

limitations addressedADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The paper establishes a clear scientific premise by citing prior research, including the pilot RCT that led to FDA clearance, and provides a logical rationale for the confirmatory trial.

Evidence

paraphrase[Introduction, paragraph 3]

“Our recent meta-analysis showed that TNS is safe with good tolerability for neurological and psychiatric conditions.”

paraphrase[Introduction, paragraph 4]

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

“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).”

Introduction ¶4Find in source

PASSReviewer 2· 90% conf

The paper establishes a clear scientific premise by citing prior research, including the pilot RCT that led to FDA clearance, and provides a logical rationale for the confirmatory trial.

Evidence

paraphrase[Introduction, paragraph 3]

paraphrase[Introduction, paragraph 4]

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

Sub-criteria

controlsN/A

power analysisADEQUATE

blinding levelsADEQUATE

outlier handlingADEQUATE

randomization unitADEQUATE

inclusion exclusionADEQUATE

randomization methodADEQUATE

replicate distinctionN/A

independent replicationN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

The trial design is rigorous: randomization method, blinding, sample size justification, inclusion/exclusion criteria, and analysis population are all adequately described.

Evidence

paraphrase[Methods, Randomization and blinding]

MethodsFind in source

paraphrase[Methods, Sample size justification]

PASSReviewer 2· 95% conf

The trial design is rigorous: randomized, double-blind, sham-controlled, with a prespecified statistical analysis plan, sample size justification, and clear inclusion/exclusion criteria.

Evidence

paraphrase[Methods, Randomization and blinding]

MethodsFind in source

paraphrase[Methods, Sample size justification]

Sub-criteria

demographicsADEQUATE

sex reportedADEQUATE

sex justifiedN/A

age weight healthADEQUATE

housing conditionsN/A

species strain sourceN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

Biological variables are well reported: sex, age, health status, and demographics are all described in detail.

Evidence

“150 (97 males, 64.7%) were enrolled in the study”

ResultsFind in source

“Participants had a mean age (s.d.) of 12.6 years (2.8)”

ResultsFind in source

paraphrase[Table 1]

“Child ethnicity | White | 61 (81.3) | 58 (77.3) | 119 (79.3)”

PASSReviewer 2· 90% conf

Demographic and clinical characteristics are well reported, including sex, age, ethnicity, and medication status.

Evidence

paraphrase[Table 1]

“Child sex at birth | Male | 49 (65.3) | 48 (64.0) | 97 (64.7)”

“White | 61 (81.3) | 58 (77.3) | 119 (79.3)”

Table 1Find in source

Sub-criteria

iacuc statementN/A

informed consentADEQUATE

irb ethics statementADEQUATE

regulatory complianceADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

Ethical approvals are fully documented: named ethics committee, regulatory approval, informed consent, and compliance with the Declaration of Helsinki.

Evidence

MethodsFind in source

“Children/adolescents and their parents/carers provided both digital and written informed consents/assents”

MethodsFind in source

“It was conducted in accordance with the 1975 Declaration of Helsinki”

MethodsFind in source

PASSReviewer 2· 95% conf

Ethical approval and consent are clearly documented with named bodies and protocol numbers.

Evidence

MethodsFind in source

“Children/adolescents and their parents/carers provided both digital and written informed consents/assents”

MethodsFind in source

Sub-criteria

mycoplasma testingN/A

reagents identifiedADEQUATE

organisms identifiedN/A

antibodies identifiedN/A

cell line authenticationN/A

software tools identifiedADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The investigational device (Monarch TNS System) is identified with manufacturer and detailed settings; software tools are identified with versions.

Evidence

“Real and sham TNS was performed with the Monarch TNS System (NeuroSigma, Inc.).”

MethodsFind in source

“Analyses were performed in Stata 18 (StataCorp LLC, version 18.0)”

Statistical analysisFind in source

“Study data were entered and managed using the MACRO Electronic Data Capture system (version 4.15.0.116).”

MethodsFind in source

PASSReviewer 2· 90% conf

The investigational device (Monarch TNS System) is identified with manufacturer and detailed settings; software tools are named with versions.

Evidence

“Real and sham TNS was performed with the Monarch TNS System (NeuroSigma, Inc.).”

MethodsFind in source

“Analyses were performed in Stata 18 (StataCorp LLC, version 18.0)”

Statistical analysisFind in source

Sub-criteria

tests namedADEQUATE

exact p valuesADEQUATE

effect sizes ciADEQUATE

data presentationADEQUATE

software identifiedADEQUATE

assumptions verifiedADEQUATE

mathematical plausibilityN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

Statistical methods are appropriate and well described; effect sizes with confidence intervals are reported; no arithmetic errors detected.

Evidence

“For the primary analysis, a longitudinal linear mixed model was used”

Statistical analysisFind in source

paraphrase[Results, Primary outcome]

“P = 0.622”

“Cohen’s d = 0.09”

ResultsFind in source

PASSReviewer 2· 90% conf

Statistical methods are appropriate and well described, with exact p-values and effect sizes with confidence intervals.

Evidence

“estimated adjusted mean difference (aMD) = 0.83; 95% confidence interval: –2.47 to 4.13; P = 0.622; Cohen’s d = 0.09”

ResultsFind in source

“P values were calculated using two-sided z -tests from the linear mixed models as outlined in methods.”

Table 2Find in source

Sub-criteria

code sharingN/A

accession numbersADEQUATE

repository depositADEQUATE

data availability statementADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

Data are deposited in a public repository with a DOI; no custom code was used.

Evidence

“All data supporting the findings of this study have been deposited in the figshare repository and are publicly available at 10.6084/m9.figshare.29414744.v1.”

Data availabilityFind in source

“No custom code was generated or used in this study.”

Data availabilityFind in source

PASSReviewer 2· 95% conf

Data are deposited in a public repository with a DOI, and a clear data availability statement is provided.

Evidence

“All data supporting the findings of this study have been deposited in the figshare repository and are publicly available at 10.6084/m9.figshare.29414744.v1.”

Data availabilityFind in source

Sub-criteria

funding coiADEQUATE

trial registrationADEQUATE

reporting guidelineADEQUATE

methods completenessADEQUATE

all outcomes reportedADEQUATE

limitations discussedADEQUATE

conclusions proportionalADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

The trial is registered, reported per CONSORT, all outcomes are reported, limitations are discussed, and funding/COI are disclosed.

Evidence

“Trial registration: ISRCTN82129325”

AbstractFind in source

paraphrase[Methods, Trial design]

“It is reported following CONSORT guidelines”

“Limitations include a high rate of missing data on teacher ratings (80%) due to low teacher participation.”

Discussion ¶7Find in source

PASSReviewer 2· 95% conf

The trial is registered, reported per CONSORT, and includes funding and COI statements; limitations are discussed.

Evidence

“Trial registration: ISRCTN82129325 (http://www.isrctn.com/ISRCTN82129325)”

AbstractFind in source

paraphrase[Methods, Trial design]

“It was conducted in accordance with the 1975 Declaration of Helsinki and is reported following CONSORT guidelines.”

“Limitations include a high rate of missing data on teacher ratings (80%) due to low teacher participation.”

Discussion ¶8Find in source

Registered (1 ID: ISRCTN). Reporting guideline cited: CONSORT.

Broken references and links

1 finding · worst low

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

Checked 63 references by DOI: 3 verified — 1 DOI unresolved, 59 no DOI (shown, not verified).

Copyediting

4 minor

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

No major wording or formatting errors. 4 minor suggestions below.

4 copyedit issues flagged: mostly consistency, typo.

Kaimen Rigor Action ItemsFinal pass before journal submission

1.
HIGHreporting
Temper the claim that the MEWS improvement may represent a clinically meaningful benefit in the Discussion, noting it was not replicated in older adolescents and could be a type I error.
The claim audit rated this as overstated; the paper's own text acknowledges the limitation.
2.
HIGHreporting
Clarify in the Results (Participant disposition) whether the four participants who turned 19 before randomization were included despite exceeding the stated age criterion, and reconcile with the inclusion criteria.
The copyedit and integrity checks flagged a potential internal contradiction with the 8-18 year inclusion criterion.
3.
HIGHreporting
Correct the handedness row in Table 1: the real TNS group percentage should be 20.0% (not 20) and the overall percentage should sum to 100% with the right-handed percentage.
The copyedit and integrity checks flagged an arithmetic inconsistency in the handedness percentages.
4.
MEDIUMreporting
Add a note in the Discussion about the potential for type I error due to multiple testing, particularly for the MEWS finding.
Reviewer 2 suggested this to improve interpretation of secondary outcomes.
5.
MEDIUMreporting
Report the exact p-values for all secondary outcomes in the tables instead of threshold-only values.
Both reviewers noted some secondary outcomes are reported as thresholds, reducing precision.
6.
MEDIUMreporting
Provide the full statistical analysis plan as a supplementary file or appendix.
Both reviewers suggested this to enhance transparency and allow independent replication.
7.
MEDIUMreporting
Include a CONSORT flow diagram in the main text (or ensure Fig. 1 is clearly labeled as such) and report the number of participants completing the 6-month follow-up.
Reviewer 2 noted the flow diagram is referenced but not explicitly included; clarifying attrition improves reporting completeness.
8.
MEDIUMdata code
Provide a data dictionary or codebook for the deposited figshare data to facilitate reuse.
Both reviewers suggested this to improve data usability.
9.
MEDIUMreporting
Add a statement in the Limitations about the generalizability of findings to non-UK settings.
Reviewer 2 suggested this to address external validity.
10.
LOWcopyedit
Fix the extra space in Table 3, Mackworth Vigilance Task commission errors row ("0.95 1" should be "0.95").
Minor typo flagged by copyedit.
11.
LOWcopyedit
Use consistent terminology ("participants" instead of "children") in the Results section.
Copyedit flagged inconsistent terminology.
12.
LOWreporting
Report the results of the CACE analysis in the main text rather than only in extended data.
Reviewer 1 suggested this to improve accessibility of sensitivity analyses.
13.
LOWreporting
Report the results of post hoc subgroup analyses in the main text or clearly label them as exploratory.
Reviewer 1 suggested this to avoid over-interpretation.
14.
LOWreporting
Report the intraclass correlation coefficient or variance components from the mixed models.
Both reviewers suggested this to aid power calculations for future trials.

Full text (69,675 chars)Analyzed: Aug 15, 2026