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

Not Applicable

Recruiting

• Conditions: Transcranial Direct Current Stimulation; Attention Deficit Hyperactivity Disorder
• Interventions: Other: Transcranial Direct Current Stimulation

• Registration Number: NCT04704687
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-08
• Study First Submitted: 2021-01-08
• Study First Submitted QC: 2021-01-08
• Study First Posted: 2021-01-12
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-21
• Last Update Posted: 2023-03-22
• Primary Completion: 2025-08
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Not provided

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham	Transcranial Direct Current Stimulation	-
tDCS	Transcranial Direct Current Stimulation	-

Primary Outcome Measures

Name	Time	Method
Variation of ADHD-RS(ADHD Rating Scale-IV) between both arms	at 4 weeks	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.

Trial Locations

Locations (1)

CHU Amiens; 🇫🇷 Amiens, France