Neurofeedback Therapy for Children Diagnosed With Autism
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Autism Spectrum Disorder
- Sponsor
- Carrick Institute for Graduate Studies
- Enrollment
- 83
- Locations
- 1
- Primary Endpoint
- Changes in qEEG
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
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)
Outcomes
Primary Outcomes
Changes in qEEG
Time Frame: Baseline and at week 12
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.
Secondary Outcomes
- Changes in Stability Score(Baseline and at week 12)
- Changes in Social Responsiveness Scale (Second Edition) SRS-2(Baseline and at week 12)
- Changes in Autism Behaviour Checklist (ABC)(Baseline and at week 12)
- The Behavior Rating Inventory of Executive Function (BRIEF)(Baseline and at week 12)
- Changes in Questions about Behavioural Function (QABF) test(Baseline and at week 12)