tES Modalities for the Treatment of ADHD

NCT ID: NCT06974136

Last Updated: 2025-05-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-30

Study Completion Date

2026-07-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Attention Deficit Disorder With Hyperactivity Neurodevelopmental Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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active tDCS group

This 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.

Group Type ACTIVE_COMPARATOR

transcranial electrical stimulation

Intervention Type 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.

active tACS group

This 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.

Group Type ACTIVE_COMPARATOR

transcranial electrical stimulation

Intervention Type 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.

sham group

This group receives sham stimulation. The stimulation duration is for 1 minuetand the device will be turned off after the stimulation

Group Type PLACEBO_COMPARATOR

transcranial electrical stimulation

Intervention Type 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.

Interventions

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transcranial electrical stimulation

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.

Intervention Type DEVICE

Other Intervention Names

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tDCS tACS

Eligibility Criteria

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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
Minimum Eligible Age

7 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Leibniz Research Centre for Working Environment and Human Factors

OTHER

Sponsor Role collaborator

RWTH Aachen University

OTHER

Sponsor Role collaborator

Institute for Research in Fundamental Sciences

UNKNOWN

Sponsor Role collaborator

The National Brain Mapping Laboratory (NBML)

OTHER

Sponsor Role lead

Responsible Party

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Mohammad Ali Salehinejad

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Institute for Research in Fundamental Sciences

Tehran, , Iran

Site Status RECRUITING

Countries

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Iran

Central Contacts

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Mohammad Ali Salehinejad Haghighi

Role: CONTACT

017642062686

Facility Contacts

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Mohammad Ali Salehinejad, PhD

Role: primary

017642062686

Other Identifiers

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IPM-NDD

Identifier Type: -

Identifier Source: org_study_id

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