tES Modalities for the Treatment of ADHD

May 8, 2025 updated by: Mohammad Ali Salehinejad, The National Brain Mapping Laboratory (NBML)

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Device: 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.
Other Names:
  • tDCS
  • tACS
Active Comparator: 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.
Device: 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.
Other Names:
  • tDCS
  • tACS
Placebo Comparator: sham group
This group receives sham stimulation. The stimulation duration is for 1 minuetand the device will be turned off after the stimulation
Device: 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.
Other Names:
  • tDCS
  • tACS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, week 2, up to 1 month after the intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline, week 2, up to 1 month after the intervention
electroencephalogram (EEG) power
Time Frame: Baseline, week 2
Change in the EEG alpha/theta/gamma power
Baseline, week 2
electroencephalogram (EEG) functional connectivity
Time Frame: Baseline, week 2
Baseline, week 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The National Brain Mapping Laboratory (NBML)

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 30, 2025

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

April 30, 2025

First Submitted That Met QC Criteria

May 8, 2025

First Posted (Actual)

May 15, 2025

Study Record Updates

Last Update Posted (Actual)

May 15, 2025

Last Update Submitted That Met QC Criteria

May 8, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IPM-NDD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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