Comparing two neurofeedback methods for treating ADHD in children and adolescents
Comparison of 2 Neurofeedback Protocols in the Treatment of Attention Deficit Hyperactivity Disorder in Children and Adolescents
This study is testing two different neurofeedback methods to see if they can help children and teens with ADHD feel less hyperactive.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 8 Years to 15 Years |
| Sex | All |
| Sponsor | Fondation Lenval Academic / other |
| Locations | 1 site (Nice) |
| Trial ID | NCT04378699 on ClinicalTrials.gov |
What this trial studies
This research aims to evaluate the effectiveness of two different neurofeedback protocols in treating Attention Deficit Hyperactivity Disorder (ADHD) in children and adolescents aged 7 to 15. The study will involve a controlled and randomized design, where participants will undergo thirty neurofeedback sessions to assess improvements in ADHD symptoms, particularly hyperactivity. Neurofeedback is a technique that helps patients learn to regulate their brain activity through visual and auditory feedback, potentially offering a non-pharmacological treatment option for ADHD. The study will monitor participants' symptoms over a six-month period following the intervention.
Who should consider this trial
Good fit: Ideal candidates for this study are children and teenagers aged 8 to 15 diagnosed with mixed-type ADHD.
Not a fit: Patients with neurological disorders, autism spectrum disorders, or those currently on psychotropic medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new, effective non-drug treatment option for children and adolescents with ADHD.
How similar studies have performed: Previous studies have shown promising results for neurofeedback in treating ADHD, indicating that this approach has potential based on existing literature.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Children or teenagers between 8 and 15 years old included * Subject with mixed-type ADHD (attention deficit hyperactivity disorder) diagnosed by a specialist physician in the field and according to Diagnosis and Statistics of Mental Disorders-5 (DSM-5) criteria. * Subject of any psychotropic treatment for at least 15 days before inclusion * Subject committing not to take any treatment during the study period, nor to participate in another therapeutic treatment in parallel. * Subject available and pledging to honor the two weekly neurofeedback sessions for 15 consecutive weeks, and be available for symptom monitoring at 6 months. * Child benefiting from a Social Security scheme. Non Inclusion Criteria: * Neurological disorders (epilepsy) * Trouble of the autistic spectrum * Active disorder without hyperactivity (TDA) * Bad understanding of the French language * Low Intellectual Level (IQ \<70 Cognitive Assessment) * Lack of understanding of the constraints inherent in the protocol * Inability to comply with the constraints of the study throughout its duration Exclusion Criteria: * premature termination of participation, withdrawal of the patient's voluntary informed consent * Investigator's or sponsor's decision * Withdrawal of consent of subjects or legal guardians
Where this trial is running
Nice
- Hôpitaux pédiatriques de Nice CHU Lenval — Nice, France (Recruiting)
Study contacts
- Principal investigator: Hervé MD CACI — Hôpitaux Pédiatriques de Nice CHU-LENVAL
- Study coordinator: Hervé MD CACI
- Email: caci.h@pediatrie-chulenval-nice.fr
- Phone: 04 92 03 05 69
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.