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NCT Number: NCT04704687

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

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.

Recruiting

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Key information

Age range

7 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CHU Amiens

Amiens, 80480, France

Location status: Recruiting

Location contact

Anne SAUVAGET, MD

SUB_INVESTIGATOR

Emmanuel POULET, MD

SUB_INVESTIGATOR

Laurent QUERNE, MD

SUB_INVESTIGATOR

Manuel BOUVARD, MD

SUB_INVESTIGATOR

Olivier BONNOT, MD

SUB_INVESTIGATOR

Patrick BERQUIN, Pr

CONTACT

[email protected]

(33)3 22 08 76 70

Pierre FOURNERET, MD

SUB_INVESTIGATOR

Renaud JARDRI, MD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • Children, male or females presenting a sufficient compliance for participate aged 7-14 years at the time of Visit 1 (Enrolment/baseline).
  • Children's parent or legally authorised representative must sign informed consent. The children must sign assent if applicable (depending of age and understanding). The principal investigator of the center where the child is included signs the document, certifying that the family and the child, or their authorised representative, have received informed consents.
  • Children meet DSM-5 criteria for ADHD (combined presentation) based on a clinical evaluation using questionnaire ADHD-Rating-Scale (ADHD-RS) and the Kiddie Schedule for Affective Disorders and Schizophrenia French version (Kiddie-SADS).
  • Subjects have a minimum ADHD-RS total score of 32 at Visit 1.
  • Children have a minimum CGI of 4 at Visit 1.
  • Children have an age-appropriate intellectual level evaluated with WISC-5 (Full IQ >80).
  • Children in which stimulant medication have been tested previously and stopped for adverse effects could be included in the study after a wash out of at least seven days.

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.

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Patrick BERQUIN, Pr

CONTACT

[email protected]

(33)3 22 08 76 70

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Collaborators

  • Centre Hospitalier Charles Perrens, Bordeaux
  • Hospices Civils de Lyon
  • Nantes University Hospital
  • University Hospital, Lille

Registry information

Acronym: STIMADHD

Important dates

Study start
2021
Primary completion
2025
Study completion
2026
First posted
Jan 12, 2021
Registry last updated
May 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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