Neurofeedback Therapy for Children Diagnosed With Autism

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

Study Description

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

• 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

Arms and Interventions

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

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

• 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

Locations

United States, Florida

Plasticity Brain Centers

Orlando, Florida, United States, 32826

Sponsors and Collaborators

Carrick Institute for Graduate Studies

Investigators

• Principal Investigator: Frederick R Carrick, PhD; Carrick Institute for Graduate Studies

More Information

Publications:

Carrick FR, Pagnacco G, Hankir A, Abdulrahman M, Zaman R, Kalambaheti ER, Barton DA, Link PE, Oggero E. The Treatment of Autism Spectrum Disorder With Auditory Neurofeedback: A Randomized Placebo Controlled Trial Using the Mente Autism Device. Front Neurol. 2018 Jul 5;9:537. doi: 10.3389/fneur.2018.00537. eCollection 2018.

• Responsible Party: Carrick Institute for Graduate Studies
• ClinicalTrials.gov Identifier: NCT02773303
• Other Study ID Numbers: CI-IRB-20160321001
• First Posted: May 16, 2016
• 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:

Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders