Evaluation of the Relationship Between Medication, Eye Movements, and Autonomic Nervous System (ANS) Functions in Children and Adolescents With ADHD

NCT07634809 | Recruiting

• 1 other identifier: Dnr 2025-08126-01
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

An increasing number of children are being diagnosed with ADHD, and the demand for ADHD medication has been rising. Although ADHD medication is often effective, this is unfortunately not the case for all children and adolescents with ADHD; furthermore, the majority of those who use the medication experience side effects of some kind. There are currently no known factors that are clearly linked to whether ADHD medications will be effective or cause significant side effects. The healthcare system therefore has limited ability to provide recommendations on ADHD medication at the individual level, which means that most children and adolescents with ADHD try medication. Studies show that 35% of children aged 4-11 and 53% of 12-17-year-olds discontinue ADHD medication within a year. Perhaps these children and adolescents could have avoided fruitless treatment attempts if the healthcare system had been able to provide better recommendations regarding when ADHD medications are most likely to be effective and tolerable treatment options. This, combined with reports of rising mental health issues and an avalanche-like increase in demand for child and adolescent psychiatric services, makes it particularly urgent to develop methods for offering effective interventions to the right patients as specifically as possible. Previous studies have not consistently identified factors (neither genetic nor other factors such as gender, age, symptom severity, symptom profile, or comorbidities) that are linked to the efficacy or side effects of ADHD medications. In this project, we will investigate whether the efficacy and side effects of ADHD medications are linked to eye movements or activity within the autonomic nervous system. The autonomic nervous system is the part of our nervous system that is not under our conscious control. It controls many bodily functions such as pupil size, heart rate, blood pressure, and reactions to stress. Eye and pupil movements are measures of where an individual's attention is directed and how activated the brain is. ADHD is a condition in which the individual has difficulty regulating attention and activity. Therefore, there may be reason to believe that eye movements could be significant in the treatment of ADHD, even though this has never been studied before. Nor has the connection between the autonomic nervous system and the effects of ADHD medications been studied previously, even though changes in heart rate and blood pressure are among the common side effects of ADHD medications. We will invite children and adolescents who are about to begin ADHD medication. Before they start taking the medication, we will measure eye movements, pupil dilation, and the pupil's reaction to light using so-called eye-tracking technology. This is done by having the child or adolescent look at a screen and follow certain instructions while the pupil's movements are measured. We will also measure heart rate variability, i.e., how much the pulse varies, which can be done by continuously measuring the pulse for 10 minutes. We will investigate whether there is a correlation between the characteristics of these eye movement, pupil, and heart factors before medication begins and the extent to which the medication produces effect and side effects. We will also analyze how these factors are affected by the medication. The advantage of these factors is that they can be measured without causing pain. Furthermore, they are objective because they measure time and distance and are therefore not dependent on anyone's personal perceptions, as is so often the case with the rating scales otherwise used in psychiatry. If we can identify correlations between eye movements and activity in the autonomic nervous system and how ADHD medications affect children and adolescents with ADHD, there is a possibility that this could be used to provide better recommendations regarding ADHD medication. Many children could then be recommended other interventions first and avoid unnecessary and unpleasant drug treatments.

Conditions

ADHD - Attention Deficit Disorder With Hyperactivity

Keywords

Attention deficit hyperactivity disorder (ADHD); eye movement; autonomic nervous system activity; medication effects; children and adolescents

Outcome Measures

Primary Outcomes (1)

• responder status

  To judge if the child is a responder to ADHD medication the SNAP-IV rating of ADHD symptoms (before and at three-month follow-up after medication start) is used. Children, who at three months have a minimum of 40% reduction in SNAP-IV score, are classified as "responders". Those who have a smaller than 20% change in SNAP-IV score are classified as "non-responders".

  three months after medication start

Secondary Outcomes (1)

• number of emerging side effects

  3 months after medication start

Study Arms (1)

Study participants

Individuals aged 6-17 years diagnosed with ADHD and about to start ADHD medication will be invited to participate in the study

Drug: metylphenidate

Interventions

metylphenidate DRUG

The participants will be patients that were assessed to be candidates for, and offered treatment with, ADHD medication of the type methylphenidate, within the ordinary CAP practice. That is, participants will not be exposed to substances they would otherwise not take.

Study participants

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Patients within participating child and adolescent psychiatry (CAP) units and who are about to start treatment with the ADHD medication methylphenidate

You may qualify if:

• ages of 6 -17
• diagnosis of ADHD and agreed to medication administration in accordance with the clinic's procedures.

You may not qualify if:

• diagnoses of arrhythmia, cardiovascular disease, or current substance use
• concurrent use of non-steroidal asthma medications or beta-blockers
• the inability to complete study participation before the participant's 18th birthday.
• severe motor impairments and visual impairments that prevent participation in eye-tracking measurements.
• caffeine intake within 4 hours prior to HRV and eye-tracking measurements

Sponsors & Collaborators

• Umeå University: lead
• Region Västerbotten: collaborator
• Stockholm University: collaborator

Study Sites (1)

BUP Umeå

Umeå, Sweden

RECRUITING

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Central Study Contacts

Linda Halldner Henriksson, MD, PhD

CONTACT

+46 73 98 117 12; linda.halldner@umu.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2026
• First Posted: June 9, 2026
• Study Start: April 10, 2026
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): November 1, 2028
• Last Updated: June 9, 2026

Record last verified: 2026-04

Locations

SE (1)