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

NCT02778360 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 179

Last updated 2017-04-05

No results posted yet for this study

Summary

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.

Conditions

  • Attention Deficit-Hyperactivity Disorder

Interventions

DEVICE

Neurofeedback NFT

The ADHD@Home Device is composed of a software for NF Training deployed on a Windows tablet, and connected to an EEG headset and an amplifier. The training is personalized according to patient's characteristics.

DRUG

Methylphenidate MPH

Drug prescribed with a first titration period until an optimal dose.

Sponsors & Collaborators

  • European Union H2020 SME Instrument

    collaborator UNKNOWN

  • Mensia Technologies SA

    lead INDUSTRY

Principal Investigators

  • Michel Du Peloux, PhD · Mensia Technologies

  • Diane Purper-Ouakil, MD/PhD · CHRU Montpellier

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
13 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-31
Primary Completion
2017-09-30
Completion
2017-09-30

Countries

  • Belgium
  • France
  • Germany
  • Spain
  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02778360 on ClinicalTrials.gov