Clinical Research Directory

An Investigational Study Examining the Efficacy of QbMobile in Treatment Monitoring in Individuals With ADHD

The current study will investigate if QbMobile can be used to improve the accuracy and objective identification of reduced ADHD symptoms in tests scores once treatment has been initiated.

A Quick and Reliable Eye Movement Test to Help Diagnose ADHD in Children.

Attention Deficit Hyperactivity Disorder (ADHD) affects more than 5 % of children and adolescents, with a globally increasing prevalence. The condition imposes a significant burden on affected individuals, their families, and healthcare systems. Early and accurate diagnosis is crucial to ensure timely therapeutic and educational interventions. However, current diagnostic practices rely heavily on clinical interviews and behavioral observations, which are inherently subjective and resource-intensive. There is a growing need for objective diagnostic tools that can complement or even partially replace current clinical assessments. One promising approach involves eye-tracking technology, as ADHD is associated with altered oculomotor control and attention-related neural circuits. These changes may be reflected in measurable eye movement parameters, including saccadic latency and fixation stability. This clinical investigation uses a certified, CE-marked medical eye-tracking device (neos™) to assess whether specific eye movement parameters can serve as objective biomarkers for ADHD. Although the device was originally designed to assess visual pathway integrity, it also captures parameters related to attention and executive function through standardized protocols. The test is examiner-independent, non-invasive, and takes approximately 10 minutes. The study is observational and non-interventional, involving two groups of participants aged 8 to 16: 50 children with a clinically confirmed diagnosis of ADHD and 50 age-matched non-ADHD controls. All participants will complete a single neos™ eye-tracking assessment. The primary hypothesis is that children with ADHD will demonstrate greater variability in saccadic latency and a higher frequency of large saccades (\> 3°) during fixation compared to controls. These differences will be analyzed as potential diagnostic biomarkers. Diagnostic accuracy will be evaluated using receiver operating characteristic (ROC) analysis, with sensitivity, specificity and area under the curve (AUC) values reported. Secondary hypotheses include: Oculomotor parameters derived from the neos™ system can distinguish between ADHD subtypes (predominantly inattentive, hyperactive-impulsive and combined). Combined oculomotor metrics correlate with ADHD symptom severity, potentially enabling a quantitative assessment of disease burden. The results of this study could pave the way for the clinical adoption of objective, scalable and rapid diagnostic tools for ADHD. Beyond clinical use, such tools may also be adapted for population screening, telemedicine or integration into consumer-grade technologies such as virtual reality headsets. By validating a market-approved device for a new mental health indication, this study represents a critical step toward bridging research and clinical application in ADHD diagnostics.

The Primary Objective of This Study is to Determine Whether Positively Framed Information (PFI) on Side Effects, Compared to Negatively Framed and Extensive Information (NFI) Can Reduce the Number and Severity of Reported Adverse Events Caused by ADHD Medication in Children Aged 7 to 17 Years.

The goal of this randomized controlled care evaluation is to determine whether positively framed and concise information (PFI), compared to negatively framed and extensive information (NFI) about adverse events can reduce the number and severity of reported adverse events caused by ADHD medication in children aged 7 to 17 years. The main questions it aims to answer are: 1. Does PFI reduce the percentage of children suffering from decreased appetite in the first 4 weeks after starting medication compared to NFI? 2. Does PFI reduce the total number of adverse events compared to NFI? 3. Does PFI lower the total score on the Pittsburgh Side Effects Rating Scale (PSRS) compared to NFI? 4. Does PFI lead to higher parental satisfaction with the explanation of adverse events compared to NFI? 5. Does PFI reduce the number of patients who discontinue medication due to adverse events compared to NFI? 6. Does PFI decrease the number of patients needing melatonin for sleeping problems due to the use of methylphenidate compared to NFI? 7. What is the relationship between baseline factors such as age, ADHD or ADD diagnosis, and gender on the number of adverse events? Researchers will compare children who receive positively framed, concise information (PFI) to those who receive negatively framed, detailed information (NFI) to determine if the framing of information affects the prevalence and severity of reported side effects, medication adherence, and parental satisfaction. Participants in this study will: * Be randomly assigned to receive either PFI or NFI about the side effects of methylphenidate. * Start taking methylphenidate according to standard care protocols. * Complete a Pittsburgh Side Effects Rating Scale (PSRS) questionnaire 4 weeks after starting medication to report any adverse events and their severity. * Parents will provide feedback on satisfaction with the explanation of side effects using a short questionnaire. This trial aims to inform best practices for communicating potential side effects to improve medication adherence and the overall treatment experience for children with ADHD and their families.