TNS has been well tolerated with high safety and compliance rates. A long-term follow-up study for TNS use in epilepsy demonstrated skin irritation as the main adverse effect from treatment.10 Other commonly reported adverse effects of short-term TNS include headache and eye twitches.9,10 Based on the 4-week double-blind sham study, the manufacturer of the Monarch-TNS treatment device also noted drowsiness, increased appetite, trouble sleeping, and fatigue as possible side effects. No withdrawal effects have been observed.
Findings from a study by McGough and colleagues10 suggest that TNS may be effective for ADHD as an alternative treatment to stimulant and non-stimulant medications given symptomatic improvement in both inattention and hyperactivity symptoms of ADHD. Although direct comparison of TNS to pharmacological treatment has not been undertaken, treatment may be considered in children with parental preference against pharmacological treatment after providing psychoeducation or in children who cannot tolerate psychotropic medications. TNS as an adjunctive therapy may also be considered; however, adjunctive use has not been studied.
Currently, several limitations remain a concern. First, clear parameters (eg, duration of treatment, number of treatments, the need for booster sessions) have not yet been identified. Second, there are no long-term studies for mood symptoms or ADHD, which limits the available data on long-term efficacy for TNS as a treatment. Third, the device itself is available but will come at a high out-of-pocket cost, thereby restricting treatment access.
Based on these limited data, TNS appears to be an effective, safe, well-tolerated option with high compliance rates. Although more studies are needed, this treatment has high potential for use in managing the symptoms associated with ADHD.
Dr Griffin is Assistant Professor of Psychiatry, the Medical Director of Outpatient Child and Adolescent Psychiatry, and the Director of the Child and Adolescent ADHD Clinic at Rush University Medical Center, Chicago, IL. Dr Harari is a first-year Child and Adolescent Psychiatry Fellow at Rush University Medical Center. The authors report no conflicts of interest concerning the subject matter of this article.
1. Moran LV, Ongur D, Hsu J, et al. Psychosis with methylphenidate or amphetamine in patients with ADHD. N Engl J Med. 2019;380:1128-1138.
2. Schiffer WK, Volkow ND, Fowler JS, et al. Therapeutic doses of amphetamine or methylphenidate differentially increase synaptic and extracellular dopamine. Synapse. 2006;59:243-51.
3. Young D, Scoville WB. Paranoid psychosis in narcolepsy and the possible danger of Benzedrine. Med Clin North Am. 1938;22:637-646.
4. Ney PG. Psychosis in a child, associated with amphetamine administration. Can Med Assoc J. 1967;97:1026-1029.
5. Lucas AR, Weiss M. Methylphenidate hallucinosis. JAMA. 1971;217:1079-1081.
6. dosReis S, Park A, Ng X, et al. Caregiver treatment preferences for children with a new versus existing attention-deficit/hyperactivity. J Child Adolesc Psychopharmacol. 2017;27:234-242.
7. Barbaresi WJ, Colligan RC, Weaver AL, et al. Mortality, ADHD, and psychosocial adversity in adults with childhood ADHD: a prospective study. Pediatrics. 2013;131:637-644.
8. Danielson ML, Bitsko RH, Ghandour RM et al. Prevalence of parent-reported ADHD diagnosis and associated treatment among U.S. children and adolescents. J Child Adolesc Psychol. 2016;47:199-212.
9. McGough JJ, Sturm A, Cowen J, et al. Double-blind, sham-controlled, pilot study of trigeminal nerve stimulation for attention-deficit/hyperactivity disorder. J Am Acad Child Adolesc Psychiatry. 2019;58:403-411.
10. McGough JJ, Loo SK, Sturm A et al. An eight-week, open-trial, pilot feasibility study of trigeminal nerve stimulation in youth with attention-deficit/hyperactivity disorder. Brain Stimul. 2015;8:299-304.