Accepted for/Published in: JMIR Neurotechnology
Date Submitted: Nov 13, 2024
Open Peer Review Period: Nov 12, 2024 - Jan 7, 2025
Date Accepted: May 15, 2025
(closed for review but you can still tweet)
Development of Neurostimulation Devices in the Treatment of Pediatric ADHD: Extraclinical Adherence Considerations
ABSTRACT
Background:
Pediatric and adolescent patients with attention deficit hyperactivity disorder (ADHD) present unique challenges as it pertains to adherence to device-based therapies outside the clinical environment. The development, approval, and availability of neurostimulation devices for the treatment of ADHD has prompted extraclinical (outside the sphere of the clinic) research on the real-world implementation of such therapies in a population that has difficulty remembering tasks and staying attentive to therapy.
Objective:
This work aims to fully understand the extraclinical pediatric ADHD treatment environment, to ensure that design considerations and stakeholder contributions to forthcoming innovations will be efficacious.
Methods:
Using the Lean LaunchPad® methodology with its emphasis on customer discovery and the Business Model Canvas, qualitative analysis methods were applied to elicit the most pertinent themes regarding ADHD treatment in children and the general perception of a new device-based treatment regimen.
Results:
Stakeholders expressed a desire that for innovative ADHD therapies to appeal to children, they include a remote adherence monitoring component, and they maintain strong evidence of efficacy.
Conclusions:
Such barriers to access and desired design features should be strongly considered in the development of neurostimulation therapies for the pediatric ADHD patient population. Pediatric and adolescent ADHD patients require attentive device design consideration to achieve therapeutic adherence in a real-world setting. Clinical Trial: IRB Study number: IRB2020-0898D IRB Title: Enhancing Therapeutic Device Adherence of Children with ADHD: An Efficacy Trial
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