NCT02773303

Neurofeedback Therapy for Children Diagnosed With Autism

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 83 (actual)
• Sponsor: Carrick Institute for Graduate Studies · Academic / Other
• Sex: All
• Age: 2 Years – 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Autism Spectrum Disorder

Interventions

Type	Name	Description
DEVICE	Mente Autism™	A portable headband records EEG activity, and specialized algorithms convert the EEG activity into sonified binaural signals feeding them back to the user
DEVICE	Sham	a device externally identical to Mente Autism™, providing binaural beats but not tailor-made neurofeedback binaural beats

Timeline

• Start date: 2016-05-01
• Primary completion: 2017-12-13
• Completion: 2017-12-13
• First posted: 2016-05-16
• Last updated: 2018-07-24

Locations

1 site across 1 country: United States