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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


Clinical Trial 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 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02773303
Study type Interventional
Source Carrick Institute for Graduate Studies
Contact
Status Completed
Phase N/A
Start date May 2016
Completion date December 13, 2017

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