Multi Neuro-functional Biomarkers for Monitoring the Effects of Treatments in ADHD Children (MIMOSA)

IRCCS Eugenio Medea

Status and phase: Enrolling; Phase 4

Conditions: Attention Deficit Hyperactivity Disorder

Treatments: Drug: Methylphenidate

Study type: Interventional

Funder types: Other

Identifiers

NCT04272021

504

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 6 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• diagnosis of ADHD according to DSM-5 (Diagnostic and Statistical Manual of Mental Disorders-5) criteria;
• drug naive

Exclusion criteria

• presence of intellectual disability, neurological diseases, epilepsy, genetic syndromes
• and previous treatment with psychoactive drugs

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

ADHD sample

Experimental group

Description:

Children with a diagnosis of ADHD

Treatment:

Drug: Methylphenidate