Effectiveness of a Personalized Neurofeedback Training Device (ADHD@Home) in Attention-Deficit/Hyperactivity Disorder (Newrofeed)

Mensia Technologies

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Attention Deficit-Hyperactivity Disorder

Treatments: Device: Neurofeedback NFT; Drug: Methylphenidate MPH

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT02778360

Newrofeed

Details and patient eligibility

About

The main objective of the study is to demonstrate the non-inferiority of the personalized Neurofeedback Training device versus Methylphenidate in the treatment of children and adolescents with Attention-Deficit/Hyperactivity Disorder.

Full description

The main objective of the present study is to demonstrate the non-inferiority of the personalized Neurofeedback Training device ADHD@Home versus Methylphenidate in the treatment of children and adolescents with Attention-Deficit/Hyperactivity Disorder.

Furthermore, it is aimed to learn more about the mechanisms underlying NeuroFeedback.

The study is prospective, multicentric (9 centres), randomised, reference drug-controlled.

ADHD@Home is a neuromarkerTM-based personalized medicine device to treat children suffering from Attention Deficit Hyperactivity Disorders (ADHD) with Neurofeedback Training (NFT) based on real time electroencephalography (EEG) signal.

Neurofeedback Training is based on direct training of brain function, by which the brain learns to function more efficiently. For each session of the ADHD@Home solution, the child is trained to modulate his brain activity in a serious game, which is a real-time metaphor of the EEG biomarker that needs to be 'normalized', following a typical operant learning process.

Enrollment: 179 estimated patients

Sex: All

Ages: 7 to 13 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Children or adolescents (male or female) aged 7-13 years
• ADHD diagnosis positive with Kiddie-Sads
• ADHD RS IV >6 for attention, with or without hyperactivity
• Patient having already had corrective actions for ADHD (formal and informal educational support, psychoeducation, psychotherapy, occupational therapy remediation, at-school programs and remediations)
• Signature of inform consent form by parent and child
• Wireless internet connection at home

Exclusion criteria

• ADHD hyperactive/Impulsive without inattention component
• Established diagnosis of epilepsy or other neurological disorders
• Severe and/or uncontrolled psychiatric disorder other than ADHD diagnosed with Kiddie-Sads such as autism, schizophrenia, severe generalized anxiety disorder, major depression or severe tics
• Patient with comorbid disorder requiring psychoactive medication other than ADHD medication
• Patient having already been treated with psycho-active drug (MPH and others) or EEG-NF for ADHD in the last 6 months, or more than 4 weeks more than 6 months ago
• Unable to use the solution (tablet use and/or headset set-up and/or understanding instructions) according to the investigator
• Absence of wireless internet connection at home
• Medical disorder requiring systemic chronic medication with confounding psychoactive effects
• IQ < 80 using the 3 subtest form of the WASI or the WISC
• Plans to move requiring centre change during the next 6 months
• Plans to start other ADHD treatment, including psychotherapy, cognitive behaviour training in the next 6 months
• Patient with chronic medical illness such as seizure, cardiac disorders, untreated thyroid disease or glaucoma (contra-indication for treatment with MPH)
• Significant suicidal risk based on clinical opinion
• Patient with prescribed dietary interventions
• Patient with a known hypersensitivity to one of the ingredients of the investigational products

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

179 participants in 2 patient groups

Neurofeedback NFT

Experimental group

Description:

Neurofeedback Training based on real time electroencephalography (EEG) signal. The patient is trained to modulate his brain activity thanks to a tablet installed with serious game. Initiation/Discovery period during 21 days: initiation and discovery sessions Treatment period during 9 weeks: 36 training sessions at home

Treatment:

Device: Neurofeedback NFT

Methylphenidate MPH

Active Comparator group

Description:

Methylphenidate long acting preparation. Open titration protocol during 21 days: 10 mg/day as a start until optimal dose is reached (maximum dose: 60 mg/day). Treatment period during 9 weeks: optimal dose with MPH LA 10 and 30 mg (dose range: 10 mg/day to 60 mg/day).

Treatment:

Drug: Methylphenidate MPH