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Completed

NCT Number: NCT02773303

Neurofeedback Therapy for Children Diagnosed With Autism

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

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Key information

Age range

2 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Plasticity Brain Centers

Orlando, Florida, 32826, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Mente Autism™

Device

A portable headband records EEG activity, and specialized algorithms convert the EEG activity into sonified binaural signals feeding them back to the user

SHAM

Device

a device externally identical to Mente Autism™, providing binaural beats but not tailor-made neurofeedback binaural beats

Primary outcomes

  1. Changes in qEEG

    Time frame: Baseline and at week 12

    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.

Secondary outcomes

  1. Changes in Stability Score

    Time frame: Baseline and at week 12

    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.

  2. Changes in Questions about Behavioural Function (QABF) test

    Time frame: Baseline and at week 12

    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.

  3. The Behavior Rating Inventory of Executive Function (BRIEF)

    Time frame: Baseline and at week 12

    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.

  4. Changes in Social Responsiveness Scale (Second Edition) SRS-2

    Time frame: Baseline and at week 12

    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.

  5. Changes in Autism Behaviour Checklist (ABC)

    Time frame: Baseline and at week 12

    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.

Other outcomes

  1. The Autism Treatment Evaluation Checklist (ATEC)

    Time frame: Baseline and at week 12

    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.

Sponsors and collaborators

Lead sponsor

Carrick Institute for Graduate Studies

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 16, 2016
Registry last updated
Jul 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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