NEUROFEEDBACK on Event-Related Potential (ERP) (MyB)

Civil Hospices of Lyon

Status: Completed

Conditions: Attention Deficit Disorder With Hyperactivity

Treatments: Other: Baseline control group; Other: Neurofeedback training; Other: Active Sham control

Study type: Interventional

Funder types: Other

Identifiers

NCT03289793

69HCL15_0214

Details and patient eligibility

About

This project aims to assess the evolution of symptoms in ADHD children from 8 to 17 years, with various types of attention training.

Different groups A, B and C will be evaluated: the first with Neurofeedback training, the second with a similar training but not indexed on brain activity and the third without training.

30 patients will be randomly assigned to groups A and B according to a ratio 2:1.

Others patients who meet the same criteria but for logistical reasons cannot comply with the training constraints will be assigned to group C.

Children included in groups A and B will participate in training sessions (Neurofeedback and control training, respectively) as well as in four evaluation sessions. Children in group C will only participate in evaluation sessions (baseline control group).

Patients of groups A and B will be followed over 6 months: 4 months of training and a follow-up evaluation 2 months after training.

Patients of group C will be followed each 2 months for 6 months. This study uses electro-encephalography measures, serious video game, neuropsychological tests and questionnaires.

It also uses actigraphy measures to evaluate sleep quality.

Enrollment: 52 patients

Sex: All

Ages: 8 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Children and teenagers aged from 8 to 17 years' old
• Children and teenagers with a deficit attention disorder with or without hyperactivity, in the mixed form or in a pure inattentive form according to Diagnostique et Statistique des troubles Mentaux (DSM)-V.
• Children and teenagers having a score in Verbal Comprehension Index (or Index Verbal Reasoning) and Perceptual Reasoning Index (or Index Reasoning fluid) ≥ 80 of WISC IV or V test, not older than two years.
• Children and teenagers without psychostimulant treatment
• Children and teenagers with psychostimulant treatment agreed to achieve a therapeutic break at each visit day and with a stable dose during all the study.
• Children and teenagers whose parents have agreed and signed informed consent form of the study.

Exclusion criteria

• Children aged less than 8 and teenagers are more than 18 years' old.
• Children and teenagers having a score in Verbal Comprehension Index (or Index Verbal Reasoning) and Perceptual Reasoning Index (or Index Reasoning fluid) < 80 of WISC IV or V test, not older than two years.
• Children and teenagers with developmental disorder except "Dys" disorders.
• Children and teenagers with pure hyperactivity (without attentional deficit)
• Children and teenagers with epilepsy except benign epilepsies (without brain damage), free of crisis for two years and without treatment.
• Children and teenagers with ADHD with conduct disorders and aggression
• Children and teenagers with ADHD and Tourette's syndrome.
• Patients treated by anti / epilepsy or psychotropic treatments (with the exception of psychostimulant treatment).
• Patients with psychostimulant treatment and whose parents aren't agreed to achieve a therapeutic break at each visit day.
• Patients with visual deficiency uncorrectable with lenses or glasses.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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52 participants in 3 patient groups

Group A

Experimental group

Description:

Children will be assigned to this group in a random fashion according to a ratio 2:1 with respect to group B (see below). 20 subjects will be included in this group.

Treatment:

Other: Neurofeedback training

Group B

Active Comparator group

Description:

Children will be assigned in this group in a random fashion. 10 subjects will be included in this group.

Treatment:

Other: Active Sham control

Group C

Active Comparator group

Description:

Will be included in this group children who meet the inclusion criteria and who, with their families, are motivated to participate in the study but cannot claim to be part of groups A or B (because of logistical constraints: living too far away to comply with the frequency of the visits required by the training). Group C allows to follow the natural evolution of children with ADHD with no intervention.

Treatment:

Other: Baseline control group