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

Launched by CENTRE HOSPITALIER UNIVERSITAIRE, AMIENS · Jan 8, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called Transcranial Direct Current Stimulation (tDCS) to see if it can help children aged 7 to 14 who have Attention Deficit Hyperactivity Disorder (ADHD). ADHD is a condition that makes it hard for kids to focus, control their impulses, and sit still, which can affect their schoolwork and daily activities. The trial will compare the effects of tDCS, a safe and non-invasive brain stimulation technique, against a sham (fake) treatment while children participate in exercises meant to improve their attention and behavior.

To be eligible for the trial, children must be between 7 and 14 years old and diagnosed with ADHD, specifically the combined type. They should show enough willingness to participate, and their parents or guardians must give consent for them to join. Children who have certain other conditions, like severe neurological issues or specific psychiatric disorders, or those currently on medication, will not be included. Participants can expect to receive tDCS sessions and take part in activities that help address their ADHD symptoms. This study aims to find out if tDCS can effectively improve focus and reduce impulsivity and hyperactivity in children with ADHD.

Gender

ALL

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.