Clinical trial NCT02773303: Neurofeedback Therapy for Children Diagnosed With Autism
Official title: Neurofeedback Therapy for Children Diagnosed With Autism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: Neurofeedback
balance, postural
postural equilibrium
EEG
Lead sponsor: Carrick Institute for Graduate Studies
Sponsor class: OTHER
First posted: 2016-05-16
Enrollment: 83
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility 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)

Primary outcomes:
measure: Changes in qEEG
timeFrame: Baseline and at week 12
Secondary outcomes:
measure: Changes in Stability Score
timeFrame: Baseline and at week 12
measure: Changes in Questions about Behavioural Function (QABF) test
timeFrame: Baseline and at week 12
measure: The Behavior Rating Inventory of Executive Function (BRIEF)
timeFrame: Baseline and at week 12
measure: Changes in Social Responsiveness Scale (Second Edition) SRS-2
timeFrame: Baseline and at week 12
measure: Changes in Autism Behaviour Checklist (ABC)
timeFrame: Baseline and at week 12
Other outcomes:
measure: The Autism Treatment Evaluation Checklist (ATEC)
timeFrame: Baseline and at week 12
Locations:
city: Orlando
country: United States
facility: Plasticity Brain Centers
state: Florida
Study officials:
affiliation: Carrick Institute for Graduate Studies
name: Frederick R Carrick, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.