Trigeminal Nerve Stimulation for Attention-Deficit/Hyperactivity Disorder: Cognitive and Electroencephalographic Predictors of Treatment Response - 23/06/21
, Giulia C. Salgari, MSc, Alissa Ellis, PhD, Jennifer Cowen, PhD, Andrea Dillon, PsyD, James J. McGough, MDAbstract |
Objective |
The current study applies a precision medicine approach to trigeminal nerve simulation (TNS), a Food and Drug Administration−approved neuromodulation treatment for attention-deficit/hyperactivity disorder (ADHD), by testing secondary outcomes of cognitive and electroencephalographic [EEG] predictors of treatment response among subjects from the original randomized controlled trial.
Method |
Children aged 8 to 12 years with ADHD, were randomized to 4 weeks of active or sham TNS treatment, after which the sham group crossed over into 4 weeks of open-label treatment. TNS treatment responders (RESP) had an ADHD Rating Scale (ADHD-RS) Total score reduction of ≥25%, whereas nonresponders (NR) had <25% reduction posttreatment. Assessments included weekly behavioral ratings and pre-/posttreatment cognitive EEG measures.
Results |
The final sample was 25 RESP and 26 NR comprising 34 male and 17 female children, with a mean (SD) age of 10.3 (1.4) years. Baseline measures that significantly differentiated RESP from NR included: lower working memory, lower spelling and mathematics achievement, deficits on behavioral ratings of executive function (BRIEF), and lower resting state EEG power in the right frontal (F4) region (all p values <.05). Compared to NRs, responders showed significantly increased right frontal EEG power with TNS treatment, which was predictive of improved executive functions and ADHD symptomatology (β = 0.65, p < .001). When EEG findings and behavior were modeled together, the area under the curve (AUC) for BRIEF Working Memory scale was 0.83 (p = .003), indicating moderate prediction of treatment response.
Conclusion |
Children with ADHD who have executive dysfunction are more likely to be TNS responders and show modulation of right frontal brain activity, improved/normalized executive functions, and ADHD symptom reduction.
Clinical trial registration information |
Developmental Pilot Study of External Trigeminal Nerve Stimulation for ADHD; clinicaltrials.gov; NCT02155608
Le texte complet de cet article est disponible en PDF.Key words : neuromodulation, electroencephalography, executive functions, BRIEF
Plan
| This study was supported by a National Institute of Mental Health grant R34 MH10182 (to Drs. McGough and Loo, Co-PIs). Study devices and some materials were provided by NeuroSigma, Inc. in response to an investigator-initiated request. |
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| Portions of this study were presented at the International Society for Child and Adolescent Psychopathology 19th Biennial Meeting; June 26−29, 2019; Los Angeles, California and the American Academy of Child and Adolescent Psychiatry 65th Annual Meeting; October 23−28, 2019; Chicago, Illinois. |
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| Dr. Loo served as the statistical expert for this research. |
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| Author Contributions |
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| Conceptualization: Loo, McGough |
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| Data curation: Loo, Salgari, Ellis, Dillon |
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| Formal analysis: Loo, Ellis |
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| Funding acquisition: Loo, McGough |
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| Investigation: Salgari, Cowen, McGough |
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| Methodology: Loo, Cowen, McGough |
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| Project administration: Cowen, Dillon, McGough |
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| Supervision: Loo |
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| Writing – original draft: Loo |
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| Writing – review and editing: Loo, Salgari, Ellis, Dillon, McGough |
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| ORCID |
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| Sandra K. Loo, PhD: 0000-0002-9108-0565 |
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| Giulia C. Salgari, MSc: 0000-0002-9533-303X |
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| Jennifer Cowen, PhD: 0000-0003-0404-6930 |
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| Andrea Dillon, PsyD: 0000-0002-2151-7776 |
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| James J. McGough, MD: 0000-0001-8007-9086 |
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| Disclosure: Dr. McGough has provided expert witness testimony for Eli Lilly and Co. and Tris Pharma and has received DSMB honoraria from Sunovion. Drs. Loo, Ellis, Cowen, Dillon and Ms. Salgari have reported no biomedical financial interests or potential conflicts of interest. |
Vol 60 - N° 7
P. 856 - juillet 2021 Retour au numéro
Article précédent
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