Actively Recruiting

Phase 3
Age: 7Years - 14Years
All Genders
NCT04704687

Clinical Efficacy and Long Term Effects of Transcranial Direct Current Stimulation (tDCS) in Children With Attention Deficit/Hyperactivity Disorder (ADHD)

Led by Centre Hospitalier Universitaire, Amiens · Updated on 2025-05-29

150

Participants Needed

1

Research Sites

259 weeks

Total Duration

On this page

Sponsors

C

Centre Hospitalier Universitaire, Amiens

Lead Sponsor

H

Hospices Civils de Lyon

Collaborating Sponsor

AI-Summary

What this Trial Is About

Attention-Deficit/Hyperactivity Disorder (ADHD) is the most commonly diagnosed neurodevelopmental disorder in childhood. Patients with ADHD present inattention, impulsivity and hyperactivity causing severe impairments on academic achievement, social and professional life and daily functioning. Medications are effective in a majority of children with ADHD, but about 30% do not respond or tolerate stimulants, and some parents refuse pharmacological treatments.Transcranial Direct Current Stimulation is a safe and non-invasive technique of brain stimulation used in several neurological and psychiatric disorders, and recently in ADHD. In patients with ADHD, tDCS stimulations targeted frontal regions improve executive and attentional functioning and daily life symptoms. The objective of this project is to evaluate the efficacy of tDCS (vs sham) during cognitive-remediation exercises on ADHD symptoms (inattention, impulsivity and hyperactivity as defined by DSM-5) in children with ADHD between 7 and 14 years of age.

CONDITIONS

Official Title

Clinical Efficacy and Long Term Effects of Transcranial Direct Current Stimulation (tDCS) in Children With Attention Deficit/Hyperactivity Disorder (ADHD)

Who Can Participate

Age: 7Years - 14Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Children aged 7 to 14 years with sufficient compliance to participate
  • Parent or legal guardian must provide signed informed consent; children must provide assent if able
  • Diagnosis of ADHD with combined presentation based on DSM-5, ADHD Rating Scale, and clinical evaluation
  • Minimum ADHD Rating Scale total score of 32 at enrollment
  • Minimum Clinical Global Impression score of 4 at enrollment
  • Age-appropriate intellectual level with a Full IQ above 80 on WISC-5
  • Children who stopped stimulant medication due to adverse effects may join after a washout period of at least 7 days
Not Eligible

You will not qualify if you...

  • Presence of neurological conditions such as epilepsy, cerebral palsy, or brain injury sequelae
  • Comorbid psychiatric disorders including conduct disorders, autism, severe OCD, mood disorders, bipolar illness, psychosis, or substance abuse
  • Current use of stimulant or psychotropic medications, benzodiazepines, antidepressants, hypnotics, or melatonin
  • Previous non-response to stimulant medication
  • Severe sleep disorders
  • Any contraindication to receiving tDCS treatment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

CHU Amiens

Amiens, France, 80480

Actively Recruiting

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Research Team

P

Patrick BERQUIN, Pr

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Clinical Efficacy and Long Term Effects of Transcranial Direct Current Stimulation (tDCS) in Children With Attention Deficit/Hyperactivity Disorder (ADHD) | DecenTrialz