NCT02773303

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
83

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

May 12, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 16, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 13, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 13, 2017

Completed
Last Updated

July 24, 2018

Status Verified

July 1, 2018

Enrollment Period

1.6 years

First QC Date

May 12, 2016

Last Update Submit

July 22, 2018

Conditions

Autism Spectrum Disorder

Keywords

Neurofeedbackbalance, posturalpostural equilibriumEEG

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Changes in Stability Score

    Baseline and at week 12

  • Changes in Questions about Behavioural Function (QABF) test

    Baseline and at week 12

  • The Behavior Rating Inventory of Executive Function (BRIEF)

    Baseline and at week 12

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

    Baseline and at week 12

  • Changes in Autism Behaviour Checklist (ABC)

    Baseline and at week 12

Other Outcomes (1)

  • The Autism Treatment Evaluation Checklist (ATEC)

    Baseline and at week 12

Study Arms (2)

Active

ACTIVE COMPARATOR

Children receiving Mente Autism™ neurofeedback therapy to use at home for 40 minutes a day for 12 weeks

Device: Mente Autism™

Control

SHAM COMPARATOR

Children not receiving neurofeedback based therapy, but receiving the Sham therapy

Device: Sham

Interventions

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

Active
ShamDEVICE

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

Control

Eligibility Criteria

Age2 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Plasticity Brain Centers

Orlando, Florida, 32826, United States

Location

Related 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.

    PMID: 30026726BACKGROUND

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Frederick R Carrick, PhD

    Carrick Institute for Graduate Studies

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 12, 2016

First Posted

May 16, 2016

Study Start

May 1, 2016

Primary Completion

December 13, 2017

Study Completion

December 13, 2017

Last Updated

July 24, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)