2 Neurofeedback Protocols in the Treatment of Attention Deficit Hyperactivity Disorder in Children and Adolescents

Fondation Lenval

Status: Enrolling

Conditions: ADHD

Treatments: Other: SMR (12-15 Hz); Other: alpha band (8 -12Hz)

Study type: Interventional

Funder types: Other

Identifiers

NCT04378699

16-HPNCL-03

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 estimated patients

Sex: All

Ages: 8 to 15 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

SMR Sensory Motor Rhythm (12-15 Hz)

Experimental group

Description:

3 X 10 SMR workout sessions (12-15 Hz) C4 unipolar placement, central region

Treatment:

Other: SMR (12-15 Hz)

the alpha band (8 -12Hz)

Experimental group

Description:

3 x 10 training sessions of the higher frequencies of the alpha band (8 -12Hz), unipolar placement Fz, fronto-central region

Treatment:

Other: alpha band (8 -12Hz)