Multi Neuro-functional Biomarkers for Monitoring the Effects of Treatments in ADHD Children
- Registration Number
- NCT04272021
- Lead Sponsor
- IRCCS Eugenio Medea
- Brief Summary
MIMOSA study aims to characterize from behavioral, neurophysiological and neurocognitive perspectives children and adolescents with attention deficit hyperactivity disorder (ADHD), in order to identify a possible biomarker of response to medication treatments. To achieve this aim, in the study children with ADHD (drug naive) are recruited and undergo behavioral and clinical screenings, neurocognitive profile, and neurophysiological evaluation with functional near infrared spectroscopy (fNIRS). ADHD group is evaluated before the beginning of medications, at first dose of medication (only imaging evaluation fNIRS), and after a period of two/three months of continuous treatment with medication.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 20
- diagnosis of ADHD according to DSM-5 (Diagnostic and Statistical Manual of Mental Disorders-5) criteria;
- drug naive
- presence of intellectual disability, neurological diseases, epilepsy, genetic syndromes
- and previous treatment with psychoactive drugs
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description ADHD sample Methylphenidate Children with a diagnosis of ADHD
- Primary Outcome Measures
Name Time Method ADHD rating scale 2-3 months Clinical improvement measured with ADHD rating scale, percentage.
- Secondary Outcome Measures
Name Time Method CGI-S 2-3 months Clinical improvement measured with CGI-s (Clinical Global Impression - severity)(minimum value: 1 = "normal, not ill"; maximun value: 7 = "very severely ill" )
Trial Locations
- Locations (1)
IRCCS Eugenio Medea
🇮🇹Bosisio Parini, Italy