Autism Spectrum DisorderNCT02773303
Neurofeedback Therapy for Children Diagnosed With Autism
A study testing Mente Autism™ in people with Autism Spectrum Disorder, run by Carrick Institute for Graduate Studies at 1 site in United States.
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 Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Mente Autism™
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 83 participants
- Where
- 1 siteUnited States
- Study dates
- May 2016to 13 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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
- Being tested
- Mente Autism™, Sham
- Keywords
- Neurofeedback, balance, postural, postural equilibrium, EEG
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
ShamDevice
a device externally identical to Mente Autism™, providing binaural beats but not tailor-made neurofeedback binaural beats
| Study group | Role | What they receive |
|---|---|---|
| Active | Active comparator | Children receiving Mente Autism™ neurofeedback therapy to use at home for 40 minutes a day for 12 weeks Receives: Device: Mente Autism™ |
| Control | Sham comparator | Children not receiving neurofeedback based therapy, but receiving the Sham therapy Receives: Device: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and at week 12
Secondary outcomes (5)
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.
Measured: Baseline and at week 12
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and at week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2016 (estimated)
- Study startMay 2016
- Primary completion13 Dec 2017
- Study completion13 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carrick Institute for Graduate Studies
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frederick R Carrick, PhD, Principal investigator, Carrick Institute for Graduate Studies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02773303
- Sponsor's protocol ID
- CI-IRB-20160321001
- Status last verified
- Jul 2018
- First submitted
- 12 May 2016
- Last updated
- 24 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 30026726
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurofeedback Therapy for Children Diagnosed With Autism
- ClinicalTrials.gov ID
- NCT02773303
- Acronym / sponsor ID
- CI-IRB-20160321001
- Conditions
- Autism Spectrum Disorder
- Keywords
- Neurofeedback, balance, postural, postural equilibrium, EEG
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Carrick Institute for Graduate StudiesUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- 13 Dec 2017 (actual)
- Study completion
- 13 Dec 2017 (actual)
- First posted
- 16 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Active comparator | Device: Mente Autism™Children receiving Mente Autism™ neurofeedback therapy to use at home for 40 minutes a day for 12 weeks |
| Control | Sham comparator | Device: ShamChildren not receiving neurofeedback based therapy, but receiving the Sham therapy |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Active |
| Shama device externally identical to Mente Autism™, providing binaural beats but not tailor-made neurofeedback binaural beats | Device | Control |
Primary outcome
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.
5 secondary outcomes
Changes in Stability Score
Time frame: Baseline and at week 12
Changes in Questions about Behavioural Function (QABF) test
Time frame: Baseline and at week 12
The Behavior Rating Inventory of Executive Function (BRIEF)
Time frame: Baseline and at week 12
Changes in Social Responsiveness Scale (Second Edition) SRS-2
Time frame: Baseline and at week 12
Changes in Autism Behaviour Checklist (ABC)
Time frame: Baseline and at week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2018.
- Background: PubMed 30026726Carrick 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frederick R Carrick, PhD principal investigator
Carrick Institute for Graduate Studies
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mente Autism™ in people with Autism Spectrum Disorder, run by Carrick Institute for Graduate Studies at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in qEEG (time frame: Baseline and at week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02773303, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2018; AzTrials last refreshed its copy on 6 Nov 2026.