Neurofeedback Therapy for Children Diagnosed With Autism

July 22, 2018 updated by: Carrick Institute for Graduate Studies

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

83

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Orlando, Florida, United States, 32826
        • Plasticity Brain Centers

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and at week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and at week 12
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.
Baseline and at week 12
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.
Baseline and at week 12
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.
Baseline and at week 12
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.
Baseline and at week 12

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and at week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Carrick Institute for Graduate Studies

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (ACTUAL)

December 13, 2017

Study Completion (ACTUAL)

December 13, 2017

Study Registration Dates

First Submitted

May 12, 2016

First Submitted That Met QC Criteria

May 13, 2016

First Posted (ESTIMATE)

May 16, 2016

Study Record Updates

Last Update Posted (ACTUAL)

July 24, 2018

Last Update Submitted That Met QC Criteria

July 22, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CI-IRB-20160321001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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