Clinical trial NCT04378699: 2 Neurofeedback Protocols in the Treatment of Attention Deficit Hyperactivity Disorder in Children and Adolescents
Official title: Comparison of 2 Neurofeedback Protocols in the Treatment of Attention Deficit Hyperactivity Disorder in Children and Adolescents
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: ADHD
Keywords: ADHD
neurofeedback
Lead sponsor: Fondation Lenval
Sponsor class: OTHER
First posted: 2020-05-07
Enrollment: 70
Sex: ALL
Minimum age (years): 8
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: single-center interventional biomedical research with direct individual benefit, randomized with two active arms (without placebo)
Primary purpose: TREATMENT

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 unknown and therefore under- diagnostic.

The investigator will performed a controlled and randomized research to compare the effects of two neurofeedback protocols on the repercussions of Attention Deficit AD / Hyperactivity Disorder (HD) symptoms, in particular the hyperactivity on which the improvements reported in the literature are less with usual protocols.

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 unknown and therefore under- diagnostic. In the symptomatic triad of inattention, impulsivity and hyperactivity, there is often a psychopathological disorder, a learning and / or sleep disorder. Medication treatment with methylphenidate is the reference in terms of prescription to reduce the symptoms of AD / HD. However, the limitations of its long-term effectiveness, tolerance of side effects, and parental distrust of psychostimulant treatment are gradually opening the door to new therapeutic approaches.

Neurofeedback is considered by the scientific world as a promising and effective neurocognitive learning technique in the treatment of Attention Deficit Disorder with Hyperactivity ADHD and several neurological and psychiatric disorders. Its principle is to increase the patient's ability to regulate his own brain activity, captured by an ElectroEncephaloGram (EEG), after visual and auditory feedback.

In this controlled and randomized research, the investigator will compare the effects of two neurofeedback protocols on the repercussions of AD / HD symptoms, in particular the hyperactivity on which the improvements reported in the literature are less with usual protocols.

Seventy children and adolescents aged 7 to 15 in two groups will benefit from thirty neurofeedback sessions each, either on a so-called Sensory Motor Rhythm (SMR) protocol or on a protocol called Upper Alpha. To date, no studies have identified the effects of a NF Upper Alpha protocol on improving sleep, hyperactivity and comorbidities in patients with ADHD in a controlled and randomized manner. nor on personality dimensions related to the processes of self-regulation of the patient involved in Neurofeedback (NF) treatment.

The investigator expects superior clinical improvement of ADHD symptoms and sleep disorders in the NF upper alpha training group in patients not following any parallel drug or therapy regimen. The investigator expects stability of the effects of treatment after several months of stopping neurofeedback sessions, without taking or recovery of psychostimulant.

This research protocol would make it possible for dozens of children and adolescents to benefit from an alternative treatment (in the absence of placebo conditions) in order to achieve a clinical improvement of at least 30% of their patients. symptoms related to AD / HD, as well as to develop a field of research still little investigated in France. On the other hand, parents would be more likely to accept effective neurofeedback treatment than psychostimulant treatment, especially since it may have side effects. In addition, the validation of clinical improvements following a neurofeedback protocol aimed at increasing the relative power of alpha waves at frontal sites would be encouraging for clinical practice and future research in this area.

Eligibility 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

Primary outcomes:
measure: Effectiveness of a neurofeedback protocol on the symptoms of Attention-Deficit with Hyperactivity Disorder (ADHD)
timeFrame: scores between baseline and after 15 weeks
Secondary outcomes:
measure: Stability of change in ADHD symptoms after 6-month follow-up
timeFrame: scores between 15 weeks and after 6 months
measure: Scores on Inattention and Hyperactivity-Impulsivity components of ADHD during a neurofeedback protocol
timeFrame: scores between baseline and after 7weeks and after 15 weeks
measure: Sleep quality during a neurofeedback protocol using a questionnaire
timeFrame: between baseline and after 15 weeks and after 6 months
measure: Executive functions rated during a neurofeedback protocol
timeFrame: scores between baseline and after 15 weeks and after 6 months
measure: Clinical Improvement during a neurofeedback protocol and after 6-month follow-up
timeFrame: Evolution between baseline and after 15 weeks and after 6 months
measure: Computerized measures of attention and impulsivity during a neurofeedback protocol
timeFrame: at baseline, after 15 weeks and after 6months
Other outcomes:
Locations:
city: Nice
country: France
facility: Hôpitaux pédiatriques de Nice CHU Lenval
Study officials:
affiliation: Hôpitaux Pédiatriques de Nice CHU-LENVAL
name: Hervé MD CACI
role: PRINCIPAL_INVESTIGATOR
References: