Neurofeedback Therapy for Children Diagnosed With Autism



Status:Completed
Conditions:Neurology, Psychiatric, Autism
Therapuetic Areas:Neurology, Psychiatry / Psychology
Healthy:No
Age Range:2 - 18
Updated:7/26/2018
Start Date:May 2016
End Date:December 13, 2017

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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

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.

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)
We found this trial at
1
site
Orlando, Florida 32826
Principal Investigator: Frederick R Carrick, PhD, FACCN
Phone: 321-868-6464
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mi
from
Orlando, FL
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