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Investigation of the Association of Multimodal Neuroimaging and Peripheral Biomarkers With Executive Functions and Emotional Regulation in Adolescents With Attention-Deficit/Hyperactivity Disorder

Investigation of the Association of Multimodal Neuroimaging and Peripheral Biomarkers With Executive Functions and Emotional Regulation in Adolescents With Attention-Deficit/Hyperactivity Disorder

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07800117
Enrollment
80
Registered
2026-09-02
Start date
2026-03-01
Completion date
2027-01-31
Last updated
2026-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Attention-Deficit/Hyperactivity Disorder (ADHD)

Keywords

ADHD, Peripheral Biomarkers, Functional Connectivity, Emotional Regulation, Executive Functions, Resting-State Functional MRI

Brief summary

The purpose of this observational study is to investigate the relationships among resting-state brain connectivity, peripheral blood biomarkers, executive functions, and emotional regulation in adolescents with attention-deficit/hyperactivity disorder (ADHD). The study will include 40 adolescents aged 10 to 18 years with ADHD and 40 age- and sex-matched healthy controls. Participants will undergo clinical and psychological assessments, resting-state functional magnetic resonance imaging, and blood sampling. Serum levels of BDNF, cortisol, IL-1α, IFN-γ, TNF-α, and IL-6 will be measured. The study will examine whether differences in brain connectivity and biomarker levels are associated with executive functioning and emotional regulation.

Detailed description

Attention-deficit/hyperactivity disorder (ADHD) is a neurodevelopmental disorder characterized by difficulties in attention, hyperactivity, and impulsivity. Although alterations in neural networks and peripheral biological processes have been investigated separately, the relationships among functional brain connectivity, peripheral biomarkers, executive functions, and emotional regulation in adolescents with ADHD remain incompletely understood. The primary aim of this study is to investigate the relationships among resting-state functional brain connectivity, peripheral serum biomarkers, executive functions, and emotional regulation in adolescents with ADHD and to compare these findings with those of healthy controls. The study will focus particularly on resting-state functional connectivity within and between brain networks, including the default mode network (DMN), executive control network (ECN), and salience network (SN). The study will include adolescents aged 10 to 18 years with ADHD and age- and sex-matched healthy controls. Participants will undergo standardized clinical and psychological assessments, resting-state functional magnetic resonance imaging (fMRI), and peripheral blood sampling. Serum concentrations of brain-derived neurotrophic factor (BDNF), cortisol, interleukin-1 alpha (IL-1α), interleukin-6 (IL-6), tumor necrosis factor-alpha (TNF-α), and interferon-gamma (IFN-γ) will be measured using enzyme-linked immunosorbent assay (ELISA). Executive functioning, emotional regulation, behavioral characteristics, and clinical symptoms will be assessed using standardized clinical and behavioral assessment instruments. Resting-state fMRI data will be processed using standard preprocessing procedures, including motion correction, coregistration, normalization, smoothing, denoising, and band-pass filtering. Functional connectivity analyses will be conducted using independent component analysis and/or seed-based correlation approaches. The study will examine whether alterations in resting-state functional connectivity and peripheral biomarker levels differ between adolescents with ADHD and healthy controls and whether these biological measures are associated with executive functioning, emotional regulation, and clinical characteristics. Associations among functional connectivity measures, serum biomarkers, and behavioral and clinical scores will also be investigated. The study is designed to contribute to a more comprehensive understanding of the neurobiological mechanisms underlying ADHD in adolescence by integrating neuroimaging, peripheral biological, and behavioral measures.

Interventions

OTHERNo Intervention

This is an observational study. No intervention or treatment is assigned to participants. Participants are assessed using clinical and neuropsychological assessments, resting-state functional magnetic resonance imaging, and peripheral blood biomarker measurements.

Sponsors

Akdeniz University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
10 Years to 18 Years
Healthy volunteers
Yes

Inclusion criteria

* Age 10-18 years, including ages 10 and 18. * Diagnosis of attention-deficit/hyperactivity disorder (ADHD) according to DSM-5 criteria. * Clinically normal intellectual capacity (IQ \>80). * Predominantly right-handed. * No acute or chronic inflammatory disease. Healthy Control Group: * Age 10-18 years, including ages 10 and 18. * No psychiatric diagnosis according to DSM-5 criteria. * Clinically normal intellectual capacity (IQ \>80). * Predominantly right-handed. * No acute or chronic inflammatory disease.

Exclusion criteria

* Age younger than 10 or older than 18 years. * Intellectual disability (IQ \<80). * Hydrocephalus or herniation. * Predominantly left-handed. * History of possible traumatic brain injury. * Current or past neurological or serious medical disease (e.g., epilepsy). * Autism spectrum disorder. * Psychotic disorder. * Mood disorder. * Conduct disorder. * Active anxiety disorder or substance use disorder. * Presence of an acute or chronic inflammatory disease.

Design outcomes

Primary

MeasureTime frameDescription
Resting-State Functional Connectivity Within and Between the Default Mode Network and Other Brain NetworksAt the baseline assessmentResting-state functional magnetic resonance imaging (fMRI) will be used to assess functional connectivity within the Default Mode Network (DMN) and between the DMN and other brain networks. Functional connectivity measures will be compared between adolescents with attention-deficit/hyperactivity disorder and healthy controls.

Secondary

MeasureTime frameDescription
Serum BDNF, Cortisol, IL-1α, IL-6, TNF-α, and IFN-γ LevelsAt the baseline assessmentSerum levels of brain-derived neurotrophic factor (BDNF), cortisol, interleukin-1 alpha (IL-1α), interleukin-6 (IL-6), tumor necrosis factor-alpha (TNF-α), and interferon-gamma (IFN-γ) will be measured and compared between adolescents with attention-deficit/hyperactivity disorder (ADHD) and healthy controls.
Executive Functioning Measured by the Behavior Rating Inventory of Executive Function (BRIEF)At the baseline assessmentExecutive functioning will be assessed using the Behavior Rating Inventory of Executive Function (BRIEF). Executive functioning scores will be examined in relation to resting-state functional connectivity and serum biomarker levels.
Emotion Regulation Difficulties Measured by the Difficulties in Emotion Regulation ScaleAt the baseline assessmentEmotion regulation difficulties will be assessed using the Difficulties in Emotion Regulation Scale. Scores will be examined in relation to resting-state functional connectivity and serum biomarker levels.

Countries

Turkey (Türkiye)

Contacts

PRINCIPAL_INVESTIGATORHicran Doğru, MD

Akdeniz University

STUDY_DIRECTORKadir Tunçer, MD

Akdeniz University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 3, 2026