Cited by 131Attention Deficit Hyperactivity DisorderVagus Nerve Stimulation ResearchTranscranial Magnetic Stimulation Studies

The DOI matches its Crossref record; 46 of the 47 references it cites were found in a registry or an index; none of the 23 sources its claims cite is checked for support yet.

Double-Blind, Sham-Controlled, Pilot Study of Trigeminal Nerve Stimulation for Attention-Deficit/Hyperactivity Disorder

Open access

McGough, James J., Sturm, Alexandra, Cowen, Jennifer, Tung, Kelly, Salgari, Giulia C., Leuchter, Andrew F., Cook, Ian A., Sugar, Catherine A., Loo, Sandra K.·2019·Journal of the American Academy of Child & Adolescent Psychiatry

DOI 10.1016/j.jaac.2018.11.013PMC PMC6481187

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Abstract

Objective Trigeminal nerve stimulation (TNS), a minimal-risk noninvasive neuromodulation method, showed potential benefits for attention-deficit/hyperactivity disorder (ADHD) in an unblinded open study. The present blinded sham-controlled trial was conducted to assess the efficacy and safety of TNS for ADHD and potential changes in brain spectral power using resting-state quantitative electroencephalography.Method Sixty-two children 8 to 12 years old, with full-scale IQ of at least 85 and Schedule for Affective Disorders and Schizophrenia-diagnosed ADHD, were randomized to 4 weeks of nightly treatment with active or sham TNS, followed by 1 week without intervention. Assessments included weekly clinician-administered ADHD Rating Scales (ADHD-RS) and Clinical Global Impression (CGI) scales and quantitative electroencephalography at baseline and week 4.Results ADHD-RS total scores showed significant group-by-time interactions (F 1,228 = 8.12, p = .005; week 4 Cohen d = 0.5). CGI-Improvement scores also favored active treatment (χ 21,168 = 8.75, p = .003; number needed to treat = 3). Resting-state quantitative electroencephalography showed increased spectral power in the right frontal and frontal midline frequency bands with active TNS. Neither group had clinically meaningful adverse events.Conclusion This study demonstrates TNS efficacy for ADHD in a blinded sham-controlled trial, with estimated treatment effect size similar to non-stimulants. TNS is well tolerated and has minimal risk. Additional research should examine treatment response durability and potential impact on brain development with sustained use.Clinical trial registration information Trigeminal Nerve Stimulation for ADHD; http://clinicaltrials.gov/; NCT02155608.

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Written from the paper’s full text.

TL;DR

In a 4-week double-blind, sham-controlled pilot, nightly trigeminal nerve stimulation (TNS) in 62 children aged 8–12 with ADHD improved clinician-rated ADHD-RS total scores versus sham (group-by-time F = 8.12, df = 1/228, p = .005; week 4 Cohen’s d = .50) and CGI-I (χ² = 8.75, df = 1/168, p = .003; NNT = 3). TNS was well tolerated with no serious adverse events, and qEEG showed increased right frontal and frontal midline spectral power with active treatment.

Key findings

ADHD-RS totals showed a significant group-by-time interaction (F = 8.12, df = 1/228, p = .005), with week 4 Cohen’s d = .50. CGI-I also favored active treatment (χ² = 8.75, df = 1/168, p = .003), NNT = 3; raw CGI-I improvement rates for active vs sham were 25% vs 13%, 34% vs 15%, 47% vs 12%, and 52% vs 14% at weeks 1–4.
Resting-state qEEG showed increased broadband power with active TNS and decreased power with sham in the right frontal region. Significant group-by-time effects occurred for right frontal F4 delta, theta, beta, and gamma bands and frontal midline Fz gamma, with trend-level effects for Fz delta, theta, and beta. Week 4 changes in F4 theta/beta and Fz gamma 1 correlated with ADHD-RS total and hyperactive/impulsive changes (r’s range −.34 to −.41).
After treatment discontinuation, ADHD-RS worsened in both groups from week 4 to week 5: active means 23.39 (SD 7.88) to 25.52 (7.84); sham 27.50 (8.08) to 29.11 (7.79). Time effect was significant (F = 6.23, df = 1/57, p = .02), with a trend for group differences (F = 4.18, df = 1/57, p = .05) but no group-by-time interaction (F = .12, df = 1/57, p = .73); week 5 Cohen’s d = .46.
No serious adverse events occurred and no participant withdrew for adverse events. Active TNS was associated with significant increases in weight and pulse versus sham, and side-effect ratings showed notable increases in fatigue, headache, and increased appetite with active TNS, and increased hyperactivity with sham.

Methods

Randomized, double-blind, sham-controlled pilot: 62 children aged 8–12 years with KSADS-diagnosed ADHD, full-scale IQ ≥ 85, baseline ADHD-RS ≥ 24, and CGI-S ≥ 4 were randomized 1:1 to active (n = 32) or sham (n = 30) TNS, stratified by low/high parent ARI scores. Treatment was nightly for 4 weeks, followed by 1 blinded week without intervention.
Outcomes included weekly clinician-administered ADHD-RS and CGI scales, parent/teacher behavioral ratings, cognitive tests, safety measures, and resting-state qEEG at baseline and week 4. qEEG data for 3 participants were excluded for movement artifact, leaving 56 participants (active n = 30; sham n = 26) for EEG analyses.
Analyses used SAS 9.4 general linear mixed models with group, time, and group-by-time predictors, subject-level random intercepts, and a piecewise linear time trend (time2 after week 1); categorical CGI-I was assessed by chi-square. Effect sizes used Cohen’s d and NNT, with uncorrected α = .05.

Limitations

The paper states the study assessed only acute 4-week response and does not inform whether additional improvement would accrue with ongoing treatment or whether benefits persist over time; it did not assess TNS as adjunctive therapy; it failed to support open-label executive functioning (BRIEF) and selected sleep (CSHQ) benefits, though mean ratings on those measures were subclinical; pulse increases were statistically significant but not clinically abnormal and may be outlier findings from a small sample; replication in additional patient groups is needed.
Evident from the text: this was a small pilot with uncorrected significance for exploratory outcomes, blinding was assessed only by parent questionnaire, qEEG analyses included 56 of 62 randomized participants, and the study does not address potential effects on brain development with sustained use.

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Crossref · 10.1016/j.jaac.2018.11.013

Cites

46 of 46 references verified0 citation errors · 0 not checkable

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Claims the paper makes

0 of 23 cited sources checked · 0 supported · 0 flagged

A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Resting-state qEEG showed increased spectral power in right frontal and frontal midline frequency bands with active TNS.”
- Also stated in: § Efficacy Measures · boosted
  “With resting state qEEG, active TNS demonstrated increased broadband power, whereas sham exhibit decreased power in the right frontal region (Figure 2).”
- Also stated in: § Efficacy Measures · plain
  “reveal significant group-by-time effects for frequency bands in the right frontal (F4 delta, theta, beta, gamma) and frontal midline (Fz gamma) channels”
§ Double-Blind, Sham-Controlled, Pilot Study of Trigeminal Nerve Stimulation for ADHD > Abstract > Results:
Load-bearingStrength:boosted· not yet calibratedCausal:direct· not yet calibrated
Tests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passes
In the paper
“with estimated treatment effect size similar to non-stimulants.”
- Also stated in: § DISCUSSION · plain
  “The week 4 medium-sized treatment effect is within the same range typically evidenced with non-stimulant ADHD medications.38”
§ Double-Blind, Sham-Controlled, Pilot Study of Trigeminal Nerve Stimulation for ADHD > Abstract > Conclusion:
What the sources say
- Not checked yetcites [38] Faraone, 2006, Comparing the efficacy of medications for ADHD using meta-analysis, MedGenMed
Load-bearingStrength:plain· not yet calibrated
Tests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passes

Show all 28 claims

It may state two separate claims as one. 45
The quote only partly states this claim. 1
Probably not a substantial claim. 9

A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“CGI-Improvement also favored active treatment (Chisq = 8.75, df = 1/168, p = .003); number-needed-to-treat (NNT) = 3.”
- Also stated in: § Efficacy Measures · plain
  “CGI-I over the 4-week course similarly favored active over sham (X2 = 8.75, df = 1/168, p = .003).”
- Also stated in: § Efficacy Measures · plain
  “Number-needed-to-treat (NNT) based on CGI-I at week 4 was 3.”
§ Double-Blind, Sham-Controlled, Pilot Study of Trigeminal Nerve Stimulation for ADHD > Abstract > Results:
Load-bearingStrength:plain· not yet calibratedCausal:direct· not yet calibrated
Tests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passes
It may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Neither group had clinically meaningful adverse events.”
- Also stated in: § Safety and Tolerability · plain
  “There were no serious adverse events in either group and no participant withdrew for adverse events.”
§ Double-Blind, Sham-Controlled, Pilot Study of Trigeminal Nerve Stimulation for ADHD > Abstract > Results:
Load-bearingStrength:plain· not yet calibrated
Tests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passes
It may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“ADHD-RS totals showed significant group-by-time interactions (F = 8.12, df = 1/228, p = .005); week 4 Cohen’s d = .5.”
- Also stated in: § Efficacy Measures · boosted
  “ADHD-RS totals showed significant group-by-time interaction, demonstrating a differential treatment effect (F = 8.12, df = 1/228, p = .005).”
- Also stated in: § Efficacy Measures · hedged
  “Estimated Cohen’s d at week 4 was 0.50, suggesting a medium-size treatment effect.”
§ Double-Blind, Sham-Controlled, Pilot Study of Trigeminal Nerve Stimulation for ADHD > Abstract > Results:
Load-bearingStrength:boosted· not yet calibratedCausal:direct· not yet calibrated
Tests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passes
It may state two separate claims as one. The quote only partly states this claim.
In the paper
“TNS is well-tolerated and minimal risk.”
- Also stated in: § DISCUSSION · boosted
  “As with previous reports, results confirm that TNS carries minimal risk and is well tolerated and accepted by ADHD-affected children and their parents.17”
§ Double-Blind, Sham-Controlled, Pilot Study of Trigeminal Nerve Stimulation for ADHD > Abstract > Conclusion:
What the sources say
- Not checked yetcites [17] McGough, 2015, An eight-week, open-trial, pilot feasibility study of trigeminal nerve stimulant in youth with attention-deficit/hyperactivity disorder, Brain Stimul source
Load-bearingStrength:boosted· not yet calibrated
Tests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passes
It may state two separate claims as one.
In the paper
“Finally, TNS is extremely well tolerated in adults and virtually without adverse events, suggesting suitability for pediatric testing.16”
§ Double-Blind, Sham-Controlled, Pilot Study of Trigeminal Nerve Stimulation for ADHD > INTRODUCTION
What the sources say
- Not checked yetcites [16] DeGiorgio, 2011, Trigeminal nerve stimulation: seminal animal and human studies for epilepsy and depression, Neurosurg Clin North Am source
Load-bearingStrength:plain· not yet calibrated
Tests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passes
It may state two separate claims as one.
In the paper
“As with the vagus nerve, TNS is known to elicit parasympathetic activity, which is expected to result in pulse decreases or bradycardia.43”
§ Double-Blind, Sham-Controlled, Pilot Study of Trigeminal Nerve Stimulation for ADHD > DISCUSSION
What the sources say
- Not checked yetcites [43] Kumada M, Dampney RA, Reis DJ. The trigeminal depressor response: a novel vasodepressor response originating from the trigeminal system. Brain Res. 177;119:305-326. source
Strength:boosted· not yet calibratedCausal:conditional· not yet calibrated
Tests✓ Asserted: passes✓ Checkable: passes? Load-bearing: unclear✓ Based: passes
It may state two separate claims as one.
None of the sources cited for this claim have been checked yet.
In the paper
“Previous scalp qEEG studies reported increased power in delta, theta, and beta frequency bands at right frontal electrodes with successful stopping within a stop signal task,39, 40 suggesting a significant association between right frontal cortex and inhibitory control.”
§ Double-Blind, Sham-Controlled, Pilot Study of Trigeminal Nerve Stimulation for ADHD > DISCUSSION
What the sources say
- Not checked yetcites [39] Huster, 2013, Electroencephalography of response inhibition tasks: functional networks and cognitive contributions, Int J Psychophysiol source
- Not checked yetcites [40] Wagner, 2018, Establishing a right frontal beta signature for stopping active in scalp electroencephalography: implications for testing inhibitory control in other task contexts, J Cognitive Neuroscience source
Load-bearingStrength:hedged· not yet calibratedCausal:correlational· not yet calibrated
Tests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passes
It may state two separate claims as one.
None of the sources cited for this claim have been checked yet.
In the paper
“Similar to the vagus nerve, the trigeminal conveys sensory inputs from skin, muscles, and skull to extensive connections within the locus coeruleus, reticular activating system, and nucleus tractus solitarius,12 regions involved in selective maintenance of attention.13”
§ Double-Blind, Sham-Controlled, Pilot Study of Trigeminal Nerve Stimulation for ADHD > INTRODUCTION
What the sources say
- Not checked yetcites [12] Nolte, 1999
- Not checked yetcites [13] Peterson, 2012, The attention system of the human brain: 20 years after, Annu Rev Neurosci source
Load-bearingStrength:plain· not yet calibratedCausal:correlational· not yet calibrated
Tests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passes
It may state two separate claims as one.
In the paper
“To assess study blinding effectiveness, parents completed an Early Impressions Questionnaire25 after the initial treatment week to quantify expectations of success with their assigned condition.”
§ Double-Blind, Sham-Controlled, Pilot Study of Trigeminal Nerve Stimulation for ADHD > METHOD > TNS Intervention
What the sources say
- Not checked yetcites [25] Devilly, 2000, Psychometric properties of the credibility/expectancy questionnaire, J Beh Ther Exp Psychiatry source
Strength:plain· not yet calibrated
Tests✓ Asserted: passes✓ Checkable: passes✗ Load-bearing: fails✓ Based: passes
Probably not a substantial claim. The paper’s conclusions may not depend on it.
In the paper
“A preliminary open trial in ADHD-diagnosed youth suggested TNS was 1) readily accepted by parents and children; 2) associated with substantial reductions in parent and clinician ADHD symptom ratings and significant improvements on multiple indices of parent-reported executive functioning; and, 3) associated with dramatic improvements in laboratory measures of response inhibition.17”
§ Double-Blind, Sham-Controlled, Pilot Study of Trigeminal Nerve Stimulation for ADHD > INTRODUCTION
What the sources say
- Not checked yetcites [17] McGough, 2015, An eight-week, open-trial, pilot feasibility study of trigeminal nerve stimulant in youth with attention-deficit/hyperactivity disorder, Brain Stimul source
Load-bearingStrength:hedged· not yet calibratedCausal:correlational· not yet calibrated
Tests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passes
It may state two separate claims as one.
In the paper
“This study demonstrated the efficacy and safety of TNS in ADHD treatment, confirming and expanding previous open-label findings.17”
§ Double-Blind, Sham-Controlled, Pilot Study of Trigeminal Nerve Stimulation for ADHD > DISCUSSION
What the sources say
- Not checked yetcites [17] McGough, 2015, An eight-week, open-trial, pilot feasibility study of trigeminal nerve stimulant in youth with attention-deficit/hyperactivity disorder, Brain Stimul source
Load-bearingStrength:boosted· not yet calibratedCausal:direct· not yet calibrated
Tests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passes
It may state two separate claims as one.
None of the sources cited for this claim have been checked yet.
In the paper
“Trigeminal nerve stimulation (TNS) is a non-invasive, minimal risk neuromodulation method approved in Canada and Europe for adult treatment of medication-resistant major depression,9, 10 and epilepsy.11”
§ Double-Blind, Sham-Controlled, Pilot Study of Trigeminal Nerve Stimulation for ADHD > INTRODUCTION
What the sources say
- Not checked yetcites [9] Schrader, 2011, Trigeminal nerve stimulation in major depressive disorder: first proof of concept in an open pilot trial, Epilepsy Behav source
- Not checked yetcites [10] Cook, 2016, Trigeminal nerve stimulation for comorbid posttraumatic stress disorder and major depressive disorder, Neuromodulation source
- Not checked yetcites [11] Cook, 2015, The potential use of trigeminal nerve stimulation in the treatment of epilepsy, Ther Deliv source
Load-bearingStrength:plain· not yet calibrated
Tests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passes
It may state two separate claims as one.

48 of 48

The authors state this as an assumption.
Benefits of vagal nerve stimulation rely in part on the same brain connections as trigeminal nerve stimulation.
“Assuming that benefits of vagal stimulation rely in part on the same brain connections, it was hypothesized that TNS similarly improve seizures and mood, but without costs and risks associated with surgical device implantation.”
The paper relies on this without support.
This is the first blinded sham-controlled trial of TNS for ADHD or any pediatric condition.
“This is the first blinded sham-controlled trial of TNS for ADHD or any pediatric condition.”

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Week 5 effect is below the paper's medium-effect cutoff
Minor
The paper defines .5 as the cutoff for a medium Cohen's d, but calls the week 5 value of .46 medium-sized.

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Authors: McGough, J. J., Sturm, A., Cowen, J., Tung, K., Salgari, G. C., Leuchter, A. F., Cook, I. A., Sugar, C. A., & Loo, S. K.
Affiliations: University of California, Los Angeles (US)
Corresponding author: McGough, James J.
ORCID: McGough, James J.
Sturm, Alexandra
Leuchter, Andrew F.
Cook, Ian A.
Sugar, Catherine A.
Loo, Sandra K.
Venue: Journal of the American Academy of Child & Adolescent Psychiatry
Publisher: Elsevier BV
Published: 2019-04
Volume: 58
Issue: 4
Pages: 403-411.e3
ISSN: 0890-8567 (ISSN-L)
DOI: 10.1016/j.jaac.2018.11.013
PMC: PMC6481187
OpenAlex: W2914647410
Semantic Scholar: 8d6d8f15fe2c3b0e48ab4ffd88fafca077c02746
Cited by: 131
References: 47
Citations by year: 2026: 14 · 2025: 20 · 2024: 21 · 2023: 23 · 2022: 15 · 2021: 18 · 2020: 12 · 2019: 7
FWCI: 10.36
Type: journal article
Language: en
Open access: bronze
doi.org
Licence: www.elsevier.com/tdm/userlicense/1.0/ (tdm)
Locations: Journal of the American Academy of Child & Adolescent Psychiatry (publishedVersion)
PubMed (publishedVersion)
PubMed Central (acceptedVersion)
eScholarship (California Digital Library) (submittedVersion)
Funders: National Institute of Mental Health (R34MH101282)
Topics: Health Sciences › Medicine › Psychiatry and Mental health › Attention Deficit Hyperactivity Disorder
Life Sciences › Neuroscience › Neurology › Vagus Nerve Stimulation Research
Life Sciences › Neuroscience › Neurology › Transcranial Magnetic Stimulation Studies
Keywords: trigeminal nerve stimulation, attention deficit hyperactivity disorder, non-invasive neuromodulation, children, quantitative EEG, treatment efficacy, treatment safety
MeSH terms: Attention Deficit Disorder with Hyperactivity, Child, Double-Blind Method, Electric Stimulation Therapy, Female, Humans, Male, Pilot Projects, Psychiatric Status Rating Scales, Trigeminal Nerve, United States, Logistic Models, Treatment Outcome, Executive Function

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Double-Blind, Sham-Controlled, Pilot Study of Trigeminal Nerve Stimulation for Attention-Deficit/Hyperactivity Disorder

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