Health TrialsbyHealthPanel

tES Modalities for the Treatment of ADHD

ConditionsAttention Deficit Disorder With HyperactivityNeurodevelopmental Disorders
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age7-18
SponsorThe National Brain Mapping Laboratory (NBML)

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosis of ADHD by a licensed psychiatrist and a behavioral checklist

being 7-18 years old

providing written informed consent signed by parents

Disqualifiers

comorbidity with other neurodevelopmental disorders

Comorbidity with other neurological disorders

previous history of neurosurgery

Presence of any ferromagnetic metal in the head

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

45 Participants
are divided into 3 treatment groups
Group A: active tDCS groupActive comparator 1 intervention
Group B: active tACS groupActive comparator 1 intervention
Group C: sham groupPlacebo comparator 1 intervention

Trial outcomes

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.

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

Secondary outcomes

1

Executive function- Performance accuracy and reaction time

Performance in an executive functions computerized task

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

electroencephalogram (EEG) power

Change in the EEG alpha/theta/gamma power

Time frame
Baseline, week 2
3

electroencephalogram (EEG) functional connectivity

Time frame
Baseline, week 2

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The National Brain Mapping Laboratory (NBML)

Lead sponsor

Leibniz Research Centre for Working Environment and Human Factors

Collaborator

RWTH Aachen University

Collaborator

Institute for Research in Fundamental Sciences

Collaborator

Source ClinicalTrials.gov
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