The efficacy of real versus sham external Trigeminal Nerve Stimulation (eTNS) in youth with Attention-Deficit/Hyperactivity Disorder (ADHD) over 4 weeks: a protocol for a multi-centre, double-blind, randomized, parallel-group, phase IIb study (ATTENS)

American Psychiatric Association. Diagnostic and statistical manual of mental disorders: DSM-5. 5th ed. Washington, D.C.: American Psychiatric Publishing; 2013.

Rubia K. Cognitive Neuroscience of Attention Deficit Hyperactivity Disorder (ADHD) and Its Clinical Translation. Front Hum Neurosci. 2018;12:100.

Article  PubMed  PubMed Central  Google Scholar 

Rubia K, Westwood S, Aggensteiner PM, Brandeis D. Neurotherapeutics for Attention Deficit/Hyperactivity Disorder (ADHD): A Review. Cells. 2021;10(8):2156.

Article  PubMed  PubMed Central  Google Scholar 

Faraone SV, Banaschewski T, Coghill D, Zheng Y, Biederman J, Bellgrove MA, et al. The World Federation of ADHD International Consensus Statement: 208 Evidence-based conclusions about the disorder. Neurosci Biobehav Rev. 2021;128:789–818.

Article  PubMed  PubMed Central  Google Scholar 

Faraone SV, A. BM, Isabell B, S C, Catharina H, Chris H, et al. Update on Attention-Deficit/Hyperactivity Disorder. Nature Reviews. 2024;10(11):1–21.

Cortese S, Adamo N, Del Giovane C, Mohr-Jensen C, Hayes AJ, Carucci S, et al. Comparative efficacy and tolerability of medications for attention-deficit hyperactivity disorder in children, adolescents, and adults: a systematic review and network meta-analysis. Lancet Psychiatry. 2018;5(9):727–38.

Article  PubMed  PubMed Central  Google Scholar 

Cunill R, Castells X, Tobias A, Capella D. Efficacy, safety and variability in pharmacotherapy for adults with attention deficit hyperactivity disorder: a meta-analysis and meta-regression in over 9000 patients. Psychopharmacology. 2016;233(2):187–97.

Article  CAS  PubMed  Google Scholar 

Aston-Jones G, Cohen JD. Adaptive gain and the role of the locus coeruleus-norepinephrine system in optimal performance. J Comp Neurol. 2005;493(1):99–110.

Article  CAS  PubMed  Google Scholar 

McGough JJ, Sturm A, Cowen J, Tung K, Salgari GC, Leuchter AF, et al. Double-Blind, Sham-Controlled, Pilot Study of Trigeminal Nerve Stimulation for Attention-Deficit/Hyperactivity Disorder. J Am Acad Child Adolesc Psychiatry. 2019;58(4):403-11.e3.

Article  PubMed  PubMed Central  Google Scholar 

Cook IA, Espinoza R, Leuchter AF. Neuromodulation for depression: invasive and noninvasive (deep brain stimulation, transcranial magnetic stimulation, trigeminal nerve stimulation). Neurosurg Clin N Am. 2014;25(1):103–16.

Article  PubMed  Google Scholar 

Aucoin R, Lewthwaite H, Ekstrom M, von Leupoldt A, Jensen D. Impact of trigeminal nerve and/or olfactory nerve stimulation on activity of human brain regions involved in the perception of breathlessness. Respir Physiol Neurobiol. 2023;311: 104036.

Article  PubMed  Google Scholar 

McGough JJ, Loo SK, Sturm A, Cowen J, Leuchter AF, Cook IA. An eight-week, open-trial, pilot feasibility study of trigeminal nerve stimulation in youth with attention-deficit/hyperactivity disorder. Brain Stimul. 2015;8(2):299–304.

Article  PubMed  Google Scholar 

Adler LD, Nierenberg AA. Review of medication adherence in children and adults with ADHD. Postgrad Med. 2010;122(1):184–91.

Article  PubMed  Google Scholar 

Dupaul DG, Power TJ, Anastopoulos AD, Reid R. ADHD Rating Scale-IV: Checklists, Norms, and Clinical Interpretations. New York: Guilford; 1998.

Google Scholar 

Goodman R. The strengths and difficulties questionnaire: A research note. J Child Psychol Psychiatry. 1997;38(5):581–6.

Article  CAS  PubMed  Google Scholar 

Conners K. Conners 3rd Edition. Manual. Toronto, Ontario, Canada: Multi-Health Systems; 2008.

Stringaris A, Goodman R, Ferdinando S, Razdan V, Muhrer E, Leibenluft E, Brotman MA. The Affective Reactivity Index: a concise irritability scale for clinical and research settings. J Child Psychol Psychiatry. 2012;53(11):1109–17.

Article  PubMed  PubMed Central  Google Scholar 

Mowlem FD, Skirrow C, Reid P, Maltezos S, Nijjar SK, Merwood A, et al. Validation of the Mind Excessively Wandering Scale and the Relationship of Mind Wandering to Impairment in Adult ADHD. J Atten Disord. 2019;23(6):624–34.

Article  PubMed  Google Scholar 

Chorpita BF, Yim L, Moffitt C, Umemoto LA, Francis SE. Assessment of symptoms of DSM-IV anxiety and depression in children: a revised child anxiety and depression scale. Behav Res Ther. 2000;38(8):835–55.

Article  CAS  PubMed  Google Scholar 

Posner K, Brown GK, Stanley B, Brent DA, Yershova KV, Oquendo MA, et al. The Columbia-Suicide Severity Rating Scale: initial validity and internal consistency findings from three multisite studies with adolescents and adults. Am J Psychiatry. 2011;168(12):1266–77.

Article  PubMed  PubMed Central  Google Scholar 

Rubia K, Smith A, Brammer M, Taylor E. Performance of children with Attention Deficit Hyperactivity Disorder (ADHD) on a test battery for impulsiveness. Child Neuropsychol. 2007;30(2):659–95.

Google Scholar 

Lichstein KL, Riedel BW, Richman SL. The Mackworth Clock Test: a computerized version. J Psychol. 2000;134(2):153–61.

Article  CAS  PubMed  Google Scholar 

Bruni O, Ottaviano S, Guidetti V, Romoli M, Innocenzi M, Cortesi F, Giannotti F. The Sleep Disturbance Scale for Children (SDSC). Construction and validation of an instrument to evaluate sleep disturbances in childhood and adolescence. J Sleep Res. 1996;5(4):251–61.

Christakou A, Murphy C, Chantiluke C, Cubillo A, Smith A, Giampietro V, et al. Disorder-specific functional abnormalities during sustained attention in youth with Attention Deficit Hyperactivity Disorder (ADHD) and with Autism. Mol Psychiatry. 2013;18(2):236–44.

Article  CAS  PubMed  Google Scholar 

Cubillo A, Smith A, Barrat N, Giampietro V, Simmons A, Brammer M, Rubia K. Drug-specific laterality effects on frontal lobe activation of Atomoxetine and Methylphenidate in ADHD boys during working memory Psychol Medicine. 2013;44(3):633–46.

Google Scholar 

Rubia K, Smith AB, Brammer MJ, Toone B, Taylor E. Abnormal brain activation during inhibition and error detection in medication-naive adolescents with ADHD. Am J Psychiatry. 2005;162(6):1067–75.

Article  PubMed  Google Scholar 

Alegria AA, Wulff M, Brinson H, Barker GJ, Norman LJ, Brandeis D, et al. Real-Time fMRI Neurofeedback in Adolescents with Attention Deficit Hyperactivity Disorder. Hum Brain Mapp. 2017;38(6):3190–209.

Article  PubMed  PubMed Central  Google Scholar 

Westwood SJ, Criaud M, Lam SL, Lukito S, Wallace-Hanlon S, Kowalczyk OS, et al. Transcranial direct current stimulation (tDCS) combined with cognitive training in adolescent boys with ADHD: a double-blind, randomised, sham-controlled trial. Psychol Med. 2021:1–16.

Lam SL, Criaud M, Lukito S, Westwood SJ, Agbedjro D, Kowalczyk OS, et al. Double-Blind, Sham-Controlled Randomized Trial Testing the Efficacy of fMRI Neurofeedback on Clinical and Cognitive Measures in Children With ADHD. Am J Psychiatry. 2022;179(12):947–58.

Article  PubMed  PubMed Central  Google Scholar 

Kaufman J, Birmaher B, Brent D, Rao U, Ryan ND. Schedule for Affective Disorders and Schizophrenia for School-age Children- present and lifetime version (K-SADS-PL). Pittsburgh: University of Pittsburgh Press; 1996.

Google Scholar 

Wechsler D. Wechsler Abbreviated Scale of Intelligence- Second Edition (WASI-II). San Antonio, Texas: APA PsycTests; 2011.

Antal A, Alekseichuk I, Bikson M, Brockmöller J, Brunoni AR, Chen R, et al. Low intensity transcranial electric stimulation: Safety, ethical, legal regulatory and application guidelines. Clin Neurophysiol. 2017;128(9):1774–809.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Shiozawa P, Silva ME, Carvalho TC, Cordeiro Q, Brunoni AR, Fregni F. Transcutaneous vagus and trigeminal nerve stimulation for neuropsychiatric disorders: a systematic review. Arq Neuropsiquiatr. 2014;72(7):542–7.

Article  PubMed  Google Scholar 

Cook IA, Abrams M, Leuchter AF. Trigeminal Nerve Stimulation for Comorbid Posttraumatic Stress Disorder and Major Depressive Disorder. Neuromodulation. 2016;19(3):299–305.

Article  PubMed  Google Scholar 

Veale JF. Edinburgh Handedness Inventory - Short Form: a revised version based on confirmatory factor analysis. Laterality. 2014;19(2):164–77.

Article  PubMed  Google Scholar 

Cubillo A, Smith A, Barrett N, Simmons A, Brammer M, V. G, Rubia K. Shared and drug-specific effects of Atomoxetine and Methylphenidate on inhibitory brain dysfunction in medication-naive ADHD boys. Cerebral Cortex. 2014;24(1):174–85.

Kowalczyk O, Cubillo A, Smith ABS, Barrett N, Giampietro V, Brammer M, et al. Methylphenidate and atomoxetine normalise fronto-parietal underactivation during sustained attention in ADHD adolescents Eur Neuropsychopharmacol. 2019;29(10):1102–16.

CAS  PubMed  Google Scholar 

Westwood SJ, Conti AA, Tang W, Xue S, Cortese S, Rubia K. Clinical and cognitive effects of external trigeminal nerve stimulation (eTNS) in neurological and psychiatric disorders: a systematic review and meta-analysis. Mol Psychiatry. 2023;28(10):4025–43.

Article  PubMed  PubMed Central  Google Scholar 

Jakobsen JC, Gluud C, Wetterslev J, Winkel P. When and how should multiple imputation be used for handling missing data in randomised clinical trials - a practical guide with flowcharts. BMC Med Res Methodol. 2017;17(1):162.

Article  PubMed  PubMed Central  Google Scholar 

Waschbusch DA, Cunningham CE, Pelham WE, Rimas HL, Greiner AR, Gnagy EM, et al. A discrete choice conjoint experiment to evaluate parent preferences for treatment of young, medication naive children with ADHD. J Clin Child Adolesc Psychol. 2011;40(4):546–61.

Article  PubMed  PubMed Central  Google Scholar 

Wang G-J, Volkow ND, Wigal T, Kollins SH, Newcorn JH, Telang F, et al. Long-Term Stimulant Treatment Affects Brain Dopamine Transporter Level in Patients with Attention Deficit Hyperactive Disorder. Plos One. 2013;8(5):e63023.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Swanson JM. Debate: Are Stimulant Medications for Attention-Deficit/Hyperactivity Disorder Effective in the Long Term? (Against). J Am Acad Child Adolesc Psychiatry. 2019;58(10):936–8.

Article  PubMed  Google Scholar 

Loo SK, Salgari GC, Ellis A, Cowen J, Dillon A, McGough JJ. Trigeminal Nerve Stimulation for Attention-Deficit/Hyperactivity Disorder: Cognitive and Electroencephalographic Predictors of Treatment Response. J Am Acad Child Adolesc Psychiatry. 2021;60(7):856-64.e1.

Article  PubMed  Google Scholar 

留言 (0)

沒有登入
gif