Status:
UNKNOWN
2 Neurofeedback Protocols in the Treatment of Attention Deficit Hyperactivity Disorder in Children and Adolescents
Lead Sponsor:
Fondation Lenval
Conditions:
ADHD
Eligibility:
All Genders
8-15 years
Phase:
NA
Brief Summary
Attention Deficit Disorder with or without Hyperactivity (ADD / H) is a public health problem since it has short and long-term consequences, affects about 5% of children of school age but remains unkn...
Detailed Description
Attention deficit disorder with or without hyperactivity (ADD / H) is a public health problem since it has short and long-term consequences, affects about 5% of children of school age but remains unkn...
Eligibility Criteria
Inclusion
- 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
- 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
- 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
Key Trial Info
Start Date :
January 21 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT04378699
Start Date
January 21 2018
End Date
December 1 2025
Last Update
September 29 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hôpitaux pédiatriques de Nice CHU Lenval
Nice, France, 06200