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This project aims:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active | Active Comparator | Children receiving Mente Autism™ neurofeedback therapy to use at home for 40 minutes a day for 12 weeks |
|
| Control | Sham Comparator | Children not receiving neurofeedback based therapy, but receiving the Sham therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Stability Score | The Stability Score is calculated as percentage ratio of the actual sway and the theoretical limit of stability. Changes in Stability Score 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The Autism Treatment Evaluation Checklist (ATEC) | 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 |
Inclusion Criteria:
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:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frederick R Carrick, PhD | Carrick Institute for Graduate Studies | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Plasticity Brain Centers | Orlando | Florida | 32826 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30026726 | Background | 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. |
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| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| Sham | Device | a device externally identical to Mente Autism™, providing binaural beats but not tailor-made neurofeedback binaural beats |
|
| Changes in Questions about Behavioural Function (QABF) test | 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 |
| The Behavior Rating Inventory of Executive Function (BRIEF) | 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 |
| Changes in Social Responsiveness Scale (Second Edition) SRS-2 | 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 |
| Changes in Autism Behaviour Checklist (ABC) | 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 |