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

Sponsor
Centre Hospitalier Universitaire, Amiens
Study ID
NCT04704687
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
7 Years - 14 Years
Healthy Volunteers
Not accepted

Interventions

  • Transcranial Direct Current Stimulation — OTHER
    Children will perform two successive interventions composed each by a set of 15 sessions of effective-tDCS combine with cognitive-training exercises.

Study Details

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.

Key Dates

Start date
Jan 8, 2021
Status verified
May 2025
Primary completion
Aug 31, 2025
Completion
Jan 31, 2026

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: tDCS
  • Active Comparator: Sham

Primary Outcome Measure

Variation of ADHD-RS(ADHD Rating Scale-IV) between both arms [ Time Frame: at 4 weeks ]

Central Contacts

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