Neurofeedback Therapy for Children Diagnosed With Autism

Study Overview
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Brief Summary
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This project aims: to further explore the effectiveness of a novel sonified Neurofeedback management therapy for children diagnosed with Autism Spectrum Disorder (ASD) to determine if balance control is different before and after therapy

Detailed Description
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Once the informed consent of a parent or guardian has been secured, each child will be asked to provide informed assent. If the child elects to participate in the research project, he/she is enrolled in the study and assign to one of two groups: Active Comparator or Sham Comparator. If possible, his/her ability to maintain balance is then assessed using a standard extended mCTSIB protocol (standing for 25 seconds on a hard surface/4 tall foam cushion with eyes open/closed and head neutral/turned right/left/flexed or extended) and his/her baseline qEEG are recorded. A series of questionnaires will be administered to the child and/or his/her parents/legal guardian/caretaker. Afterward the child will be instructed to wear the prescribed device (either the Active Comparator (Mente Autism™) or the Sham Comparator (a device externally identical to Mente Autism™, providing binaural beats but not tailor-made neurofeedback binaural beats)) to use at home for 40 minutes a day for 12 weeks. At the end of the 12 weeks treatment period, the child will again be tested as at the beginning of the trial (posturography, qEEG, and questionnaires). At the end of the study, participants in the Sham Comparator group will be offered the option of receiving the full therapy.

Official Title
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Neurofeedback Therapy for Children Diagnosed With Autism

Conditions
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Autism Spectrum Disorder

Intervention / Treatment
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* Device: Mente Autism™
* Device: Sham


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: a clear diagnosis of ASD and a high starting delta wave level, as confirmed by the initial qEEG. Furthermore, since the therapy is administered via a device requiring to be connected to a computer, tablet or phone with WiFi capabilities to work, the following are additional requirement: iPhone 4s or later or all iPads except first generation iPAD running OS v7 or later, or computer running Windows 7 or later Tablet running Android 4.1 or later Internet connection Exclusion Criteria: a history of hearing impairment and co-morbidities such as Rett-Syndrome and if they get low delta wave recordings in frontal lobe with qEEG (part of the baseline testing battery)

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active<br>Children receiving Mente Autism™ neurofeedback therapy to use at home for 40 minutes a day for 12 weeks | Device: Mente Autism™<br>* A portable headband records EEG activity, and specialized algorithms convert the EEG activity into sonified binaural signals feeding them back to the user<br>|
| Sham Comparator: Control<br>Children not receiving neurofeedback based therapy, but receiving the Sham therapy | Device: Sham<br>* a device externally identical to Mente Autism™, providing binaural beats but not tailor-made neurofeedback binaural beats<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in qEEG | Changes will be assessed between baseline (at enrollment) and after the treatment period. It will be used to investigate if Mente Autism™ therapy affect it and how much. | Baseline and at week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Stability Score | The Stability Score is calculated as percentage ratio of the actual sway and the theoretical limit of stability. Changes in Stability Score will be assessed between baseline (at enrollment) and after the treatment period. It will be used to investigate if Mente Autism™ therapy affect it and how much. | Baseline and at week 12 | 
| Changes in Questions about Behavioural Function (QABF) test | Changes will be assessed between baseline (at enrollment) and after the treatment period. It will be used to investigate if Mente Autism™ therapy affect it and how much. | Baseline and at week 12 | 
| The Behavior Rating Inventory of Executive Function (BRIEF) | Changes will be assessed between baseline (at enrollment) and after the treatment period. It will be used to investigate if Mente Autism™ therapy affect it and how much. | Baseline and at week 12 | 
| Changes in Social Responsiveness Scale (Second Edition) SRS-2 | Changes will be assessed between baseline (at enrollment) and after the treatment period. It will be used to investigate if Mente Autism™ therapy affect it and how much. | Baseline and at week 12 | 
| Changes in Autism Behaviour Checklist (ABC) | Changes will be assessed between baseline (at enrollment) and after the treatment period. It will be used to investigate if Mente Autism™ therapy affect it and how much. | Baseline and at week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neurofeedback, balance, postural, postural equilibrium, EEG