Neurofeedback Therapy for Children Diagnosed With Autism

Autism Spectrum Disorder Clinical Trial

Official title:

Neurofeedback Therapy for Children Diagnosed With Autism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02773303
• Other study ID #: CI-IRB-20160321001
• Status: Completed
• Phase: N/A
• Start date: May 2016
• Est. completion date: December 13, 2017

Study information

• Verified date: July 2018
• Source: Carrick Institute for Graduate Studies
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: December 13, 2017
• Est. primary completion date: December 13, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 18 Years

Eligibility

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)

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder

Intervention

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

Locations

Country	Name	City	State
United States	Plasticity Brain Centers	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Carrick Institute for Graduate Studies

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The Autism Treatment Evaluation Checklist (ATEC)	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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