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Tests treatment safety and results for Attention Deficit Hyperactivity Disorder
Official title Clinical Efficacy and Long Term Effects of Transcranial Direct Current Stimulation (tDCS) in Children With Attention Deficit/Hyperactivity Disorder (ADHD)
ClinicalTrials.gov ID: NCT04704687
What this study is testing
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 7 to 14
You may be able to join if
- 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...
- Children meet DSM-5 criteria for ADHD (combined presentation) based on a clinical evaluation using questionnaire ADHD-Rating-Scale (ADHD-RS) and the...
- people have a minimum ADHD-RS total score of 32 at Visit 1.
- Children have a minimum CGI of 4 at Visit 1.
You likely can't join if
- 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...
- Children under medication (stimulant or other psychotropic treatment, benzodiazepine, antidepressant, hypnotics and melatonin) or who did not respond...
- Severe sleep disorder.
- Contraindication to tDCS.
See the full 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...
- 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...
- people 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Amiens, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 7 years to 14 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Amiens, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.