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

NCT04704687 | Recruiting Phase 3

• 1 other identifier: PI2018_843_0069
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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

Attention Deficit Hyperactivity Disorder; Transcranial Direct Current Stimulation

Keywords

Attention Deficit Hyperactivity Disorder; Transcranial Direct Current Stimulation

Outcome Measures

Primary Outcomes (1)

• Variation of ADHD-RS(ADHD Rating Scale-IV) between both arms

  The ADHD Rating Scale-IV is completed independently by the parent and scored by a clinician. The scale consists of 2 subscales: inattention (9 items) and hyperactivity-impulsivity (9 items). If 3 or more items are skipped, the clinician should use extreme caution in interpreting the scale. Results from this rating scale alone should not be used to make a diagnosis. How to Score For inattention (IA) subscale raw score: Add the odd-numbered items For hyperactivity-impulsivity (HI) subscale raw score: Add the even-numbered items To obtain the total raw score: Add the IA and Hi subscale raw scores Convert the raw scores to percentile scores by using the appropriate scoring profile provided on the back of the rating scale.

  at 4 weeks

Study Arms (2)

tDCS

EXPERIMENTAL

Other: Transcranial Direct Current Stimulation

Sham

ACTIVE COMPARATOR

Other: Transcranial Direct Current Stimulation

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.

Sham; tDCS

Eligibility Criteria

• Age: 7 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may not qualify if:

• Children have a neurological pathology or handicap: Epilepsy, cerebral palsy, sequelae of brain injury (traumatic or ischemic or inflammatory...)
• Children have a comorbid psychiatric disorder: conduct disorders, autism, severe obsessive-compulsive disorder, mood disorder, bipolar illness, conduct disorder, psychosis, and substance abuse.
• Children under medication (stimulant or other psychotropic treatment, benzodiazepine, antidepressant, hypnotics and melatonin) or who did not respond previously to stimulant will not be included.
• Severe sleep disorder.
• Contraindication to tDCS.

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead
• Hospices Civils de Lyon: collaborator
• Nantes University Hospital: collaborator
• Centre Hospitalier Charles Perrens, Bordeaux: collaborator
• University Hospital, Lille: collaborator

Study Sites (1)

CHU Amiens

Amiens, 80480, France

RECRUITING

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Central Study Contacts

Patrick BERQUIN, Pr

CONTACT

(33)3 22 08 76 70; berquin.patrick@chu-amiens.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2021
• First Posted: January 12, 2021
• Study Start: January 8, 2021
• Primary Completion: August 1, 2025
• Study Completion: January 1, 2026
• Last Updated: May 29, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)