Autism Spectrum Disorder Clinical Trial
Official title:
Neurofeedback Therapy for Children Diagnosed With Autism
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 Autismâ„¢) or the Sham Comparator (a device externally identical to Mente
Autismâ„¢, 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.
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