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Neurofeedback Therapy for Children Diagnosed With Autism

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ClinicalTrials.gov Identifier: NCT02773303
Recruitment Status : Completed
First Posted : May 16, 2016
Last Update Posted : July 24, 2018
Sponsor:
Information provided by (Responsible Party):
Carrick Institute for Graduate Studies

Study Description
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Brief Summary:

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

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Device: Mente Autism™ Device: Sham Not Applicable

Detailed Description:

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 83 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Neurofeedback Therapy for Children Diagnosed With Autism
Study Start Date : May 2016
Actual Primary Completion Date : December 13, 2017
Actual Study Completion Date : December 13, 2017

Resource links provided by the National Library of Medicine


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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   2 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02773303


Locations
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United States, Florida
Plasticity Brain Centers
Orlando, Florida, United States, 32826
Sponsors and Collaborators
Carrick Institute for Graduate Studies
Investigators
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Principal Investigator: Frederick R Carrick, PhD Carrick Institute for Graduate Studies
More Information
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Publications:

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Responsible Party: Carrick Institute for Graduate Studies
ClinicalTrials.gov Identifier: NCT02773303    
Other Study ID Numbers: CI-IRB-20160321001
First Posted: May 16, 2016    Key Record Dates
Last Update Posted: July 24, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Carrick Institute for Graduate Studies:
Neurofeedback
balance, postural
postural equilibrium
EEG
Additional relevant MeSH terms:
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Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders