Status:
RECRUITING
Clinical Efficacy and Long Term Effects of Transcranial Direct Current Stimulation (tDCS) in Children With Attention Deficit/Hyperactivity Disorder (ADHD)
Lead Sponsor:
Centre Hospitalier Universitaire, Amiens
Collaborating Sponsors:
Hospices Civils de Lyon
Nantes University Hospital
Conditions:
Attention Deficit Hyperactivity Disorder
Transcranial Direct Current Stimulation
Eligibility:
All Genders
7-14 years
Phase:
PHASE3
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 s...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
January 8 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT04704687
Start Date
January 8 2021
End Date
January 1 2026
Last Update
May 29 2025
Active Locations (1)
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1
CHU Amiens
Amiens, France, 80480