Bradley Hospital has initiated a groundbreaking clinical trial exploring accelerated intermittent theta burst stimulation (iTBS) as a tool to improve critical cognitive functions such as working memory and inhibitory control in adolescents diagnosed with Attention-Deficit/Hyperactivity Disorder (ADHD). Recognized as one of the largest studies in this domain, the trial, currently recruiting participants, highlights promising advancements in medical device interventions for neurodevelopmental disorders.
What changed?
The announcement, dated October 22, 2025, marks substantial progress in the use of non-invasive stimulation devices for adolescent ADHD management. It specifically focuses on leveraging iTBS, a technique already utilized in psychiatric care, to address the cognitive challenges often experienced by individuals with ADHD. This study could redefine therapeutic practices and performance-based metrics in neurological care.
Study details and goals
Sponsored by Bradley Hospital, the trial aims to compare the efficacy of iTBS stimulation targeting working memory versus inhibitory control pathways. The device used delivers brief magnetic pulses to stimulate brain networks associated with specific cognitive functions. Researchers hope to gauge the impact on ADHD-related impairments like attention regulation and impulsivity.
Participant criteria
Currently recruiting, the study seeks adolescent participants diagnosed with ADHD. Rigorous eligibility requirements are applied to ensure consistent and measurable findings.
Expected outcomes
The trial’s primary goal is to track changes in cognitive abilities, particularly working memory and inhibitory control. Secondary goals include assessing behavioral improvements and safety profiles. All results will comply with established medical device regulations and research standards.
Key clinical implications of iTBS
Intermittent theta burst stimulation is already FDA-cleared for applications such as depression treatment. Its potential application in ADHD management opens doors to personalized, device-based interventions. By precisely targeting neural networks, this treatment may offer unique advantages over pharmaceutical approaches, emphasizing safety and precision while minimizing side effects.
Evidence-based regulation
Any device deployed in this trial adheres to medical device regulation standards, including performance, safety, and clinical reliability validations in line with MDR Annex XIV.
Future exploration
While this study focuses on adolescents, successful outcomes may catalyze further investigations into broader age groups and other mental health disorders. Additionally, the findings could influence how regulatory agencies assess similar therapeutic medical devices.
FAQ
1. What is intermittent theta burst stimulation (iTBS)?
iTBS is a non-invasive brain stimulation method that delivers short magnetic bursts to specific neural networks, aiming to enhance cognitive or emotional functioning.
2. What are the study’s main objectives?
The study intends to identify whether targeted iTBS can improve working memory or inhibitory control in adolescents with ADHD.
3. Is iTBS approved for ADHD treatment?
As of now, iTBS is approved for other conditions such as depression. The trial will help authorities assess its potential for ADHD patients.
4. Who is eligible to participate?
The trial seeks adolescents diagnosed with ADHD who meet the specific inclusion criteria set by Bradley Hospital.
Conclusion
This ongoing clinical trial represents a significant milestone in ADHD treatment, harnessing advanced medical device technology to improve cognitive functioning. Healthcare professionals and regulatory bodies should closely monitor its outcomes to understand its implications in reshaping the ADHD treatment landscape.
Disclaimer
This content is provided for informational purposes and does not constitute legal or medical advice. Readers should consult regulatory standards and certified professionals for specific guidance.
Announcement link
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07219810?term=medical+device