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    Interventional procedure overview of transcutaneous electrical stimulation of the trigeminal nerve for ADHD

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    Efficacy summary

    ADHD-specific symptom and behavioural measures

    ADHD-RS

    In a randomised controlled trial (RCT) of 62 children (32 who had active treatment and 30 who had sham treatment), total ADHD-RS scores decreased from 32.1 (standard deviation [SD] 6.3) at baseline to 23.39 (SD 7.88) at week 4 in the active treatment group. In the sham group, ADHD-RS total scores decreased from 32.8 (SD 6.2) at baseline to 27.50 (SD 8.08) at week 4. There was a statistically significant group-by-time interaction, indicating a differential treatment effect between the groups (F=8.12, df=1/228, p=0.005). Estimated Cohen's d at week 4 was 0.50, suggesting a medium treatment effect. After treatment discontinuation for 1 week, week 5 ADHD-RS total scores were 25.52 (SD 7.84) and 29.11 (SD 7.79) (McGough, 2019).

    In a secondary analysis of data from McGough (2019), 51 participants were divided into responders (n=25) and non-responders (n=26) (20 people randomised to sham crossed over after the initial 4-week treatment period and were included in this analysis) (Loo, 2021). Responders were those with a 25% or greater reduction in ADHD-RS total score from baseline to end of treatment. Responders and non-responders were then compared to determine if any measures were predictive of treatment response. The following measures were statistically significant predictors of end of treatment ADHD-RS total score:

    • CBCL sluggish cognitive tempo (β=-0.40, 95% CI -0.68 to -0.14, p=0.004)

    • BRIEF working memory (β=-0.40, 95% CI -0.70 to -0.14, p=0.004), planning (β=-0.36, 95% CI -0.51 to -0.08, p=0.01) and metacognition (β=-0.32, 95% CI -0.57 to -0.04, p=0.02)

    • EEG right-frontal theta (β=0.43, 95% CI 0.2 to 1.1, p=0.005) and alpha band power (β=0.45, 95% CI 0.3 to 1.2], p=0.003).

    Statistically significant group-by-time interactions indicated that TNS responders showed treatment-related improvement in BRIEF scores that were not observed in non-responders:

    • metacognition (F(1,45)=38.6, p<0.001, partial eta squared=0.47: large effect size)

    • working memory (F(1,45)=41.1, p<0.001, partial eta squared=0.48: large effect size)

    • initiate (F(1,45)=18.3, p<0.001, partial eta squared=0.29: large effect size)

    • planning (F(1,45)=36.7, p=0.001, partial eta squared=0.51: large effect size)

    • organisation (F(1,45)=19, p=0.001, partial eta squared=0.30: large effect size)

    Treatment-related change in these BRIEF variables and ADHD-RS total scores were very strongly correlated, with Pearson r's ranging from 0.65 (planning, p=6.5E-7) to 0.79 (working memory, p=3.0E-11).

    In an open-label trial of 22 children, there was a statistically significant decrease in ADHD-RS scores from baseline to week 8 (F=42.5, df=2/40, p<0.0001) (McGough, 2015).

    Conners Global Index

    In the RCT of 62 children, there were no statistically significant group-by-time interactions observed for Conners Global Index scores (McGough, 2019).

    Other symptom and behavioural measures

    CGI-I

    In the RCT of 62 children, there was a statistically significantly greater improvement in CGI-I score with active treatment compared with sham treatment (X2=8.75, df=1/168, p=0.003). Improvement rates for active compared with sham treatment were 25% versus 13%, 34% versus 15%, 47% versus 12%, and 52% versus 14%, respectively, based on raw CGI-I at weeks 1, 2, 3, and 4, respectively. The number needed to treat (NNT) based on CGI-I at week 4 was 3 (McGough, 2019).

    In the open-label trial of 22 children, there was a statistically significant decrease in CGI-I scores from baseline to week 8 (F=6.89, df=8/140, p<0.0001). A total of 64% children met the response criteria (improved or very much improved) at week 4, and 71% met these criteria at week 8 (McGough, 2015).

    CSHQ

    In the RCT of 62 children, there were no statistically significant group-by-time interactions observed for CSHQ scores (McGough, 2019).

    In the open-label trial of 22 children, there were statistically significant improvements in CSHQ scores for sleep anxiety (p=0.03), total bedtime problems (p<0.0001), and total sleep problems (p<0.0001) from baseline to 8-week follow up. There were no statistically significant improvements in CSHQ scores for bedtime resistance, sleep onset delay, sleep duration, night wakings, parasomnias, disordered breathing, daytime sleepiness, total sleep behaviour problems, and total problems daytime sleepiness (all p≥0.05) (McGough, 2015).

    ARI

    In the RCT of 62 children, there were no statistically significant group-by-time interactions observed for ARI scores (McGough, 2019).

    Anxiety and depression

    In the RCT of 62 children, there were no statistically significant group-by-time interactions observed for MASC or CDRS scores (McGough, 2019).

    In the open-label trial of 22 children, there were statistically significant improvements in dimensional CDI scores (F=3.40, df=2/38, p=0.04), and no statistically significant changes in self-reported MASC scores (p=0.82). (McGough, 2015).

    Cognitive measures

    BRIEF

    In the RCT of 62 children, there were no statistically significant group-by-time interactions observed for BRIEF scores (McGough, 2019).

    In the open-label trial of 22 children, there were statistically significant improvements in 7 of 11 BRIEF subscales, including inhibit (p=0.004), BRI index (p=0.03), working memory, (p=0.0004), plan/organise (p=0.004), monitor (p=0.003), MI index (p=0.0008), and global exec composite (p=0.002). There were no statistically significant improvements in 4 of 11 BRIEF subscales: shift, emotional control, initiate and organisation materials (all p>0.05) (McGough, 2015).

    ANT

    In the open-label trial of 22 children, there was a statistically significant decrease in ANT incongruent reaction time from baseline to 8-week follow up (p=0.006). There were no statistically significant changes in ANT neutral reaction time, neutral accuracy, congruent reaction time, congruent accuracy or incongruent accuracy (all p>0.05) (McGough, 2015).

    SWM

    In the open-label trial of 22 children, there were no statistically significant changes in SWM subscales from baseline to 8-week follow up (McGough, 2015).