Attention Deficit Disorder With Hyperactivity, Neurodevelopmental Disorders
Conditions
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.
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.
Interventions
DEVICEtranscranial 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.
Sponsors
The National Brain Mapping Laboratory (NBML)
RWTH Aachen University
Institute for Research in Fundamental Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
7 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
Countries
Iran
Outcome results
None listed