Attention deficit/hyperactivity disorder (ADHD) Mental and Behavioural Disorders
Conditions
Interventions
This is an observational study investigating electroencephalogram (EEG)-based biomarkers for ADHD diagnosis in children aged 7 to 12.
Participants undergo a comprehensive assessment that includes cli
CPT-3 and ENFEN for attention, processing speed, and executive functions
SDQ, CABI, and ADHD Rating Scale-IV for behavioral and emotional regulation
PROLEXIA for dyslexia screening
and CCI-2 for slow cognitive tempo), alongside EEG recordings during both resting state and a go/no-go interference task with varying stimulus ratios to evaluate brain connectivity, response inhibitio
Sponsors
Bitsphi Diagnosis
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged between 7 and 12 years (inclusive). 2. Right-handed dominance. 3. Written informed consent from a legal representative and assent from the participant. 4. (Cases) Diagnosed with ADHD within the past 3 years or at the time of the study, with hyperactive/impulsive, combined, or inattentive presentation, including cases with dyslexia or slow cognitive tempo (SCT). 5. (Controls) Patients from the Pediatrics Department at HUPHM, whose medical care will not be compromised by participation (e.g., those monitored for short stature, hypercholesterolemia, early pubarche, or heart murmurs/chest pain).
Exclusion criteria
Exclusion criteria: 1. Color blindness or any other condition affecting sensorineural perception, which may interfere with study procedures. 2. Cognitive or behavioral difficulties (pathological or not) or insufficient capacity, as determined by the investigator, to maintain a minimum level of relaxation and rest or to understand and follow study procedures. 3. Regular use of medications (excluding ADHD treatment) that may affect attentional or executive function, such as opioid analgesics, benzodiazepines, hypnotics, or sedative antihistamines, or any other drug deemed relevant by the investigator. 4. (Cases) Subjects for whom stopping ADHD medication for 24 hours (methylphenidate/atomoxetine) or 48 hours (other ADHD medications) poses a medical, behavioral, or other risk. 5. (Cases) Subjects for whom a medication change (different drug) was required after initial stabilization for clinical stabilization reasons, except for adjustments made during holidays or weekends. 6. Diagnosis of ADHD subtypes not considered in the inclusion criteria or presence of other neurological or psychiatric disorders significant enough to interfere with study evaluations, such as autism spectrum disorders, Tourette’s syndrome, or epilepsy (or epileptic foci). 7. (Control) Participants who meet the diagnostic criteria for ADHD or other significant mental health conditions, as determined by the research team using DSM-5 criteria and the SDQ questionnaire.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The diagnostic accuracy of the EEG-based index test for ADHD, defined by its sensitivity (true positive fraction) and specificity (false positive fraction). These metrics are derived from EEG functional connectivity patterns recorded during a standardized go/no-go interference task. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Comparison with CPT-3 Performance measured by comparing classification probabilities (e.g., sensitivity and specificity) of the EEG-based index test with those obtained from the Continuous Performance Test (CPT-3). 2. Influence of Demographic and Clinical Factors assessed via regression analyses correlating participant characteristics (such as age, sex, ADHD subtype, and comorbidities) with the diagnostic performance metrics. 3. Construct Validity of Slow Cognitive Tempo (SCT) measured using scores from the Child Concentration Inventory-Version 2 (CCI-2) and correlating these with EEG biomarkers. 4. EEG Biomarker Identification determined through dimensional reduction techniques and fuzzy deep neural network analyses to identify the most informative EEG connectivity metrics. | — |
Countries
Spain
Contacts
Public ContactSandra Ortiz
Outcome results
None listed