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tES Modalities for the Treatment of ADHD

NCT06974136 — Not applicable, Completed, 45 participants, The National Brain Mapping Laboratory (NBML)
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Transcranial Electrical Stimulation Modalities for the Treatment of Clinical Symptoms and Cognitive Deficits in Attention-deficit Hyperactivity Disorder Disorder

RegistryNCT06974136
StatusCompleted
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: triple, treatment
Enrollment45 (Actual)
SponsorThe National Brain Mapping Laboratory (NBML) (Other); collaborators: RWTH Aachen University, Institute for Research in Fundamental Sciences (IPM)
ConditionsAttention Deficit Disorder With Hyperactivity, Neurodevelopmental Disorders
Interventionstranscranial electrical stimulation (Device)
Datesstart 2025-03-30, primary completion 2026-03-01, completion 2026-05-01, first posted 2025-05-15, last updated 2026-08-04
Locations1 site in Iran

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-Summary

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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+Detailed description

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.

+Arms and interventions

ArmTypeInterventionsDescription
active tDCS groupActive comparatorDevice: transcranial electrical stimulationThis group receives Transcranial Direct Current Stimulation (tDCS). tDCS delivers a constant, low-intensity direct current (typically 1-2 mA) through electrodes placed on the scalp. The anode (positive electrode) increases cortical excitability by depolarizing neurons, while the cathode (negative electrode) decreases excitability by hyperpolarizing neurons.
active tACS groupActive comparatorDevice: transcranial electrical stimulationThis group receives Transcranial Alternating Current Stimulation (tACS). tACS applies an oscillating current at specific frequencies (e.g., 1-100 Hz) to entrain or synchronize neural oscillations. By aligning the stimulation frequency with endogenous brain rhythms (e.g., theta or gamma bands), tACS can modulate network dynamics, potentially normalizing aberrant oscillatory patterns associated with disorders like ADHD.
sham groupPlacebo comparatorDevice: transcranial electrical stimulationThis group receives sham stimulation. The stimulation duration is for 1 minuetand the device will be turned off after the stimulation
  • transcranial electrical stimulation (Device), also known as tDCS, tACS: 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.

+Outcome measures

Primary outcomes

  • ADHD symptoms- Clinical rating scale [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

  • Executive function- Performance accuracy and reaction time [Baseline, week 2, up to 1 month after the intervention]: Performance in an executive functions computerized task
  • electroencephalogram (EEG) power [Baseline, week 2]: Change in the EEG alpha/theta/gamma power
  • electroencephalogram (EEG) functional connectivity [Baseline, week 2]

+Eligibility

Sex: All, ages: 7 Years to 18 Years

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

+Locations (1)

FacilityCityCountryStatus
Institute for Research in Fundamental SciencesTehranIran

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