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).
BMC Psychiatry
; 24(1): 326, 2024 Apr 30.
Article
en En
| MEDLINE
| ID: mdl-38689273
ABSTRACT
BACKGROUND:
Attention Deficit/Hyperactivity Disorder (ADHD), if severe, is usually treated with stimulant or non-stimulant medication. However, users prefer non-drug treatments due to side effects. Alternative non-medication treatments have so far only shown modest effects. External trigeminal nerve stimulation (eTNS) is a minimal risk, non-invasive neuromodulation device, targeting the trigeminal system. It was approved for ADHD in 2019 by the USA Food and Drug administration (FDA) based on a small proof of concept randomised controlled trial (RCT) in 62 children with ADHD showing improvement of ADHD symptoms after 4 weeks of nightly real versus sham eTNS with minimal side effects. We present here the protocol of a larger confirmatory phase IIb study testing efficacy, longer-term persistency of effects and underlying mechanisms of action.METHODS:
A confirmatory, sham-controlled, double-blind, parallel-arm, multi-centre phase IIb RCT of 4 weeks of eTNS in 150 youth with ADHD, recruited in London, Portsmouth, and Southampton, UK. Youth with ADHD will be randomized to either real or sham eTNS, applied nightly for 4 weeks. Primary outcome is the change in the investigator-administered parent rated ADHD rating scale. Secondary outcomes are other clinical and cognitive measures, objective hyperactivity and pupillometry measures, side effects, and maintenance of effects over 6 months. The mechanisms of action will be tested in a subgroup of 56 participants using magnetic resonance imaging (MRI) before and after the 4-week treatment.DISCUSSION:
This multi-centre phase IIb RCT will confirm whether eTNS is effective in a larger age range of children and adolescents with ADHD, whether it improves cognition and other clinical measures, whether efficacy persists at 6 months and it will test underlying brain mechanisms. The results will establish whether eTNS is effective and safe as a novel non-pharmacological treatment for ADHD. TRIAL REGISTRATION ISRCTN82129325 on 02/08/2021, https//doi.org/10.1186/ISRCTN82129325 .Palabras clave
ADHD; Attention-Deficit; EF; Executive functions; External transcutaneous Trigeminal Nerve Stimulation; External trigeminal nerve stimulation; Functional magnetic resonance imaging; Hyperactivity Disorder; Supraorbital transcutaneous stimulation; TENS; TNS; Transcutaneous electrical nerve stimulation; Transcutaneous external supraorbital nerve stimulation; Transcutaneous supraorbital nerve stimulation; Trigeminal nerve stimulation; Trigeminal transcutaneous nerve stimulation; eTNS; fMRI
Texto completo:
1
Banco de datos:
MEDLINE
Asunto principal:
Trastorno por Déficit de Atención con Hiperactividad
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Nervio Trigémino
Límite:
Adolescent
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Child
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Female
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Humans
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Male
Idioma:
En
Año:
2024
Tipo del documento:
Article