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

NCT04378699 | Unknown

• 1 other identifier: 16-HPNCL-03
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

ADHD

Keywords

ADHD; neurofeedback

Outcome Measures

Primary Outcomes (1)

• Effectiveness of a neurofeedback protocol on the symptoms of Attention-Deficit with Hyperactivity Disorder (ADHD)

  ADHD symptoms will be assessed using the clinician version of the 18-item Attention-Deficit with Hyperactivity rating scale IV (ADHD-RS). Each item is scored on a 0-3 scale with 0 representing the absence of the behavior/symptom and 3 representing the very frequent and impairing behavior/symptom over the last months. Two subscales compose ADHD-RS: 9-item Inattention subscale (range: 0-27) and a Hyperactivity-Impulsivity subscale (range: 0-27). The total ADHD-RS score is the sum of the two subscale scores and ranges from 0 to 54. Effectiveness of a neurofeedback protocol on the training capacity will be defined as a decrease of at least 30% the ADHD-RS total score between baseline, after 15 workout sessions of neurofeedback (2 sessions per week) and another 15 workout sessions of neurofeedback (2 sessions per week). Patients completing the study will therefore have undergone 30 workout sessions of neurofeedback

  scores between baseline and after 15 weeks

Secondary Outcomes (6)

• Stability of change in ADHD symptoms after 6-month follow-up

  scores between 15 weeks and after 6 months

• Scores on Inattention and Hyperactivity-Impulsivity components of ADHD during a neurofeedback protocol

  scores between baseline and after 7weeks and after 15 weeks

• Sleep quality during a neurofeedback protocol using a questionnaire

  between baseline and after 15 weeks and after 6 months

• Executive functions rated during a neurofeedback protocol

  scores between baseline and after 15 weeks and after 6 months

• Clinical Improvement during a neurofeedback protocol and after 6-month follow-up

  Evolution between baseline and after 15 weeks and after 6 months

Study Arms (2)

SMR Sensory Motor Rhythm (12-15 Hz)

EXPERIMENTAL

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

Other: SMR (12-15 Hz)

the alpha band (8 -12Hz)

EXPERIMENTAL

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

Other: alpha band (8 -12Hz)

Interventions

SMR (12-15 Hz) OTHER

SMR training sessions (12-15 Hz) C4 unipolar placement, central region

SMR Sensory Motor Rhythm (12-15 Hz)

alpha band (8 -12Hz) OTHER

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

the alpha band (8 -12Hz)

Eligibility Criteria

• Age: 8 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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 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.
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondation Lenval: lead

Study Sites (1)

Hôpitaux pédiatriques de Nice CHU Lenval

Nice, 06200, France

RECRUITING

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Hervé MD CACI

  Hôpitaux Pédiatriques de Nice CHU-LENVAL

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hervé MD CACI

CONTACT

04 92 03 05 69; caci.h@pediatrie-chulenval-nice.fr

Olivier Mr BAILET

CONTACT

04 92 0 34011; bailet.o2@chu-nice.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: single-center interventional biomedical research with direct individual benefit, randomized with two active arms (without placebo)

Study Record Dates

• First Submitted: November 7, 2017
• First Posted: May 7, 2020
• Study Start: January 21, 2018
• Primary Completion: January 1, 2025
• Study Completion: December 1, 2025
• Last Updated: September 29, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)