tES Modalities for the Treatment of ADHD

NCT06974136 | Recruiting

• 1 other identifier: IPM-NDD
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Attention Deficit Disorder With Hyperactivity; Neurodevelopmental Disorders

Outcome Measures

Primary Outcomes (1)

• ADHD symptoms- Clinical rating scale

  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 Outcomes (3)

• Executive function- Performance accuracy and reaction time

  Baseline, week 2, up to 1 month after the intervention

• electroencephalogram (EEG) power

  Baseline, week 2

• electroencephalogram (EEG) functional connectivity

  Baseline, week 2

Study Arms (3)

active tDCS group

ACTIVE COMPARATOR

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

active tACS group

ACTIVE COMPARATOR

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

sham group

PLACEBO COMPARATOR

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

Interventions

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.

Also known as: tDCS, tACS

active tACS group; active tDCS group; sham group

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• The National Brain Mapping Laboratory (NBML): lead
• Leibniz Research Centre for Working Environment and Human Factors: collaborator
• RWTH Aachen University: collaborator
• Institute for Research in Fundamental Sciences: collaborator

Study Sites (1)

Institute for Research in Fundamental Sciences

Tehran, Iran

RECRUITING

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Neurodevelopmental Disorders

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Central Study Contacts

Mohammad Ali Salehinejad Haghighi

CONTACT

017642062686; salehinejadmohammadali@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 30, 2025
• First Posted: May 15, 2025
• Study Start: March 30, 2025
• Primary Completion: March 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: May 15, 2025

Record last verified: 2025-05

Locations

IR (1)