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NCT Number: NCT06974136

tES Modalities for the Treatment of ADHD

This project investigates the efficacy of transcranial electrical stimulation (tES) modalities, specifically transcranial direct current stimulation (tDCS) and transcranial alternating current stimulation (tACS), for treating Attention-Deficit/Hyperactivity Disorder (ADHD) in children and adolescents.

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Key information

Conditions

Attention Deficit Disorder With Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

7 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute for Research in Fundamental Sciences

Tehran, Iran

Location status: Recruiting

Location contact

Mohammad Ali Salehinejad, PhD

CONTACT

[email protected]

017642062686

About this study

This project aims to evaluate the therapeutic potential of transcranial electrical stimulation (tES) modalities, specifically transcranial direct current stimulation (tDCS) and transcranial alternating current stimulation (tACS), as innovative, non-invasive interventions for managing Attention-Deficit/Hyperactivity Disorder (ADHD) in children and adolescents. ADHD is a neurodevelopmental disorder characterized by persistent inattention, hyperactivity, and impulsivity that impair daily functioning. Conventional treatments, such as pharmacological interventions and behavioral therapies, may have limitations, including side effects or variable efficacy, prompting the exploration of neuromodulation techniques like tES.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of ADHD by a licensed psychiatrist and a behavioral checklist
  • being 7-18 years old
  • providing written informed consent signed by parents

Exclusion criteria

  • comorbidity with other neurodevelopmental disorders
  • Comorbidity with other neurological disorders
  • previous history of neurosurgery
  • Presence of any ferromagnetic metal in the head
  • implanted medical devices in the head or neck region
  • history of non-controlled epilepsy with seizures in the last year

Treatment and study plan

Transcranial Electrical Stimulation

Device

Transcranial electrical stimulation (tES) is a non-invasive neuromodulation technique that applies low-intensity electrical currents to the scalp to modulate brain activity. It targets specific brain regions to influence neuronal excitability, connectivity, and plasticity, offering potential therapeutic benefits for neurological and psychiatric conditions. tES is portable, cost-effective, and generally well-tolerated, with minimal side effects such as mild tingling or itching at the stimulation site.

Other names: tDCS, tACS

Primary outcomes

  1. ADHD symptoms- Clinical rating scale

    Time frame: Baseline, week 2, up to 1 month after the intervention

    ADHD symptoms will be assessed using a DSM-based structured interview. This approach involves a systematic, standardized method to evaluate the presence and severity of ADHD symptoms based on the diagnostic criteria outlined in the Diagnostic and Statistical Manual of Mental Disorders (DSM), likely the DSM-5, which is widely used for diagnosing ADHD.

Secondary outcomes

  1. Executive function- Performance accuracy and reaction time

    Time frame: Baseline, week 2, up to 1 month after the intervention

    Performance in an executive functions computerized task

  2. electroencephalogram (EEG) power

    Time frame: Baseline, week 2

    Change in the EEG alpha/theta/gamma power

  3. electroencephalogram (EEG) functional connectivity

    Time frame: Baseline, week 2

Study contacts

Contact information is provided by the study sponsor or research team.

Mohammad Ali Salehinejad Haghighi

CONTACT

[email protected]

017642062686

Sponsors and collaborators

Lead sponsor

The National Brain Mapping Laboratory (NBML)

Other

Collaborators

  • Institute for Research in Fundamental Sciences
  • Leibniz Research Centre for Working Environment and Human Factors
  • RWTH Aachen University

Registry information

Official study title

Transcranial Electrical Stimulation Modalities for the Treatment of Clinical Symptoms and Cognitive Deficits in Attention-deficit Hyperactivity Disorder Disorder

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 15, 2025
Registry last updated
May 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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