Using brain stimulation to help children with ADHD
Clinical Efficacy and Long Term Effects of Transcranial Direct Current Stimulation (tDCS) in Children With Attention Deficit/Hyperactivity Disorder (ADHD)
This study is testing if a type of brain stimulation can help children with ADHD focus better and control their impulses during special exercises.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 7 Years to 14 Years |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire, Amiens Academic / other |
| Locations | 1 site (Amiens) |
| Trial ID | NCT04704687 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of Transcranial Direct Current Stimulation (tDCS) in children aged 7-14 diagnosed with Attention Deficit Hyperactivity Disorder (ADHD). The study compares the effects of tDCS against a sham treatment during cognitive-remediation exercises to assess improvements in symptoms such as inattention, impulsivity, and hyperactivity. The trial aims to provide a non-invasive alternative for children who do not respond to traditional stimulant medications. Participants will undergo a thorough evaluation to ensure they meet the necessary criteria for inclusion.
Who should consider this trial
Good fit: Ideal candidates are children aged 7-14 who meet DSM-5 criteria for ADHD and have a significant level of symptoms as measured by specific rating scales.
Not a fit: Patients who do not meet the diagnostic criteria for ADHD or those who have not tolerated stimulant medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a new, non-invasive treatment option for children with ADHD who struggle with conventional medications.
How similar studies have performed: Previous studies have shown promising results using tDCS for ADHD, indicating potential for this approach to be effective.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Amiens
- CHU Amiens — Amiens, France (Recruiting)
Study contacts
- Study coordinator: Patrick BERQUIN, Pr
- Email: berquin.patrick@chu-amiens.fr
- Phone: (33)3 22 08 76 70
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.