NCT04704687 Clinical Efficacy and Long Term Effects of Transcranial Direct Current Stimulation (tDCS) in Children With Attention Deficit/Hyperactivity Disorder (ADHD)
| NCT ID | NCT04704687 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Centre Hospitalier Universitaire, Amiens |
| Condition | Attention Deficit Hyperactivity Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2021-01-08 |
| Primary Completion | 2025-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 150 participants in total. It began in 2021-01-08 with a primary completion date of 2025-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
* 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04704687 clinical trial?
This trial is open to participants of all sexes, aged 7 Years or older, up to 14 Years, studying Attention Deficit Hyperactivity Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04704687 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 150 participants.
Is NCT04704687 currently recruiting?
Yes, NCT04704687 is actively recruiting participants. Contact the research team at berquin.patrick@chu-amiens.fr for enrollment information.
Where is the NCT04704687 trial being conducted?
This trial is being conducted at Amiens, France.
Who is sponsoring the NCT04704687 clinical trial?
NCT04704687 is sponsored by Centre Hospitalier Universitaire, Amiens. The trial plans to enroll 150 participants.