tES Modalities for the Treatment of ADHD

The National Brain Mapping Laboratory (NBML)

Status: Enrolling

Conditions: Attention Deficit Disorder With Hyperactivity; Neurodevelopmental Disorders

Treatments: Device: transcranial electrical stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06974136

IPM-NDD

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 estimated patients

Sex: All

Ages: 7 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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45 participants in 3 patient groups, including a placebo group

active tDCS group

Active Comparator group

Description:

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.

Treatment:

Device: transcranial electrical stimulation

active tACS group

Active Comparator group

Description:

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.

Treatment:

Device: transcranial electrical stimulation

sham group

Placebo Comparator group

Description:

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

Treatment:

Device: transcranial electrical stimulation