Executive FunctioningNCT04221620
Effectiveness of EEG Neurofeedback in Pediatric Occupational Therapy to Improve Executive Functioning
A study testing Zengar Electroencephalogram (EEG) Neurofeedback device in people with Executive Functioning and Pediatric ALL, run by Northern Arizona University at 1 site in United States.
Trial summary
EEG Neurofeedback is a noninvasive way that allows the central nervous system to self regulate and the frontal cortex to be accessed through quieting of the limbic system at the subcortical level. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Executive Functioning, Pediatric ALL
- What is being tested?
- Zengar Electroencephalogram (EEG) Neurofeedback device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2020to Jul 2021
- 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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- school aged children: ages 6 to 18 years old.
- score of 4 out of 9 on the BRIEF-2 assessment, indicating a potentially clinically elevated or clinically elevated need for therapeutic intervention
Who cannot join
- score of 3 or less of the 9 categories on the BRIEF
- ratings that are equal to or higher than 7 on the inconsistency scale (indicating parent/caregiver bias)
- age requirements not met
Trial locations and contacts
1 site in 1 country.
United States1 site
Kidabilities Occupational Therapy
Prescott, Arizona, 86305
Lauren Hall, OTD, 623-606-0883, laurenhallotd@gmail.com
Catherine Young, MOT, 9286428747, catherine_young_@gmail.com
About this study
EEG Neurofeedback is a noninvasive way that allows the central nervous system to self regulate and the frontal cortex to be accessed through quieting of the limbic system at the subcortical level. Currently there is limited research in regards to the implications of EEG Neurofeedback, however, the investigators of this study have been using EEG Neurofeedback as a passive modality in the treatment of various pediatric clients with a variety of diagnoses and disorders. The purpose of this study is to determine whether or not EEG neurofeedback is effective in improving executive functioning skills in pediatric, school aged children as a modality in traditional occupational therapy services. The investigators hypothesize that EEG neurofeedback will assist with improved sensory gating abilities, therefore allowing for higher levels of cognition and awareness due to increased opportunities for the brain to regulate itself.
Read the detailed description
Electroencephalogram (EEG) Neurofeedback is a noninvasive way to allow the central nervous system to self regulate and calm the brain enough to allow the frontal cortex to function in an ideal state, which is the part of the brain that controls important functions including behavior, problem solving, memory, language, emotions, and judgment. There is limited research in regards to the use of EEG Neurofeedback, however, occupational therapists Cat Young and Lauren Hall have been using EEG Neurofeedback alongside traditional therapy as 'background noise' with pediatric clients. These therapists have observed children experience steady increases in speech and language abilities, self-care tasks such as becoming potty trained, and better abilities to understand self-regulation of emotions with EEG Neurofeedback when used together with traditional occupational therapy services. EEG Neurofeedback is performed via a musical medley that lasts for about 34 minutes, with baseline numbers taken at the beginning and after the music finishes. During this time, the participant will wear headphones, sensory clips on the ears (3 total), and two sensors on their head.
The purpose of this study is to test the effectiveness of EEG Neurofeedback in improving executive functioning skills in pediatric school aged children. The investigators hypothesize is that the EEG Neurofeedback will allow the body to filter out unnecessary information and white noise to focus on the task at hand, and therefore access higher levels of cognition and awareness by helping the brain to regulate itself. This study does not require additional time outside of the therapy session. Some of these clients already received treatment in therapy. The purpose of this consent form is to use the data gained from the client's BRIEF-2 scores and therapy sessions to test effectiveness of this device.
Furthermore, the purpose of the study is to determine potential benefits of using EEG Neurofeedback alongside traditional occupational therapy in improving executive functioning skills in school aged children. Requirements include children who experience impairments based on scores of potentially clinically elevated or clinically elevated levels on the Behavior Rating Inventory of Executive Function 2, or the BRIEF-2. This assessment is considered the gold standard for testing executive functioning and has over 1000 peer reviewed articles. At time of evaluation, the parent(s) or legal caregiver(s) will be given one (1) BRIEF-2 parental rating scale, which will take an average of 10-15 minutes to complete. Each question will be answered via a three point scale for whether they see the specific behavior often, sometimes, or never. Potential benefits include improved ability to stay on task, organize and complete tasks. There is minimal risk associated with the use of EEG Neurofeedback. Children might experience discomfort with the sensors placed on their head and attached to their ears. Some children might initially feel uncomfortable with the experience of being a relaxed alert state if they are prone to being in heightened alert states.
- Conditions
- Executive Functioning, Pediatric ALL
- Being tested
- Zengar Electroencephalogram (EEG) Neurofeedback device
- Keywords
- EEG neurofeedback, occupational therapy
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zengar Electroencephalogram (EEG) Neurofeedback deviceDevice
Electroencephalogram (EEG) Neurofeedback is a noninvasive way to allow the central nervous system to self regulate and calm the brain enough to allow the frontal cortex to function in an ideal state, which is the part of the brain that controls important functions including behavior, problem solving, memory, language, emotions, and judgment. EEG Neurofeedback is performed via a musical medley that lasts for about 34 minutes, with baseline numbers taken at the beginning and after the music finishes. During this time, the participant will wear headphones, sensory clips on the ears (3 total), and two sensors on their head while receiving traditional occupational therapy services.
| Study group | Role | What they receive |
|---|---|---|
| EEG neurofeedback | Experimental | All participants will receive 20 sessions of traditional occupational therapy services while receiving EEG neurofeedback. Receives: Device: Zengar Electroencephalogram (EEG) Neurofeedback device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Executive functioning improvements
Executive functioning improvements as indicated by improved scores on the Behavior Rating Inventory of Executive Functioning second edition, or BRIEF-2, at the end of 20 sessions when EEG neurofeedback was utilized. The BRIEF-2 is considered the gold standard for testing executive functioning and has over 1000 peer reviewed articles. It utilizes three different scoring sub-sections- typical, potentially clinically elevated. or clinically elevated. Participants in this study must score within the potentially clinically elevated or clinically elevated levels to qualify. Ideally, moving up one section to typical range or potentially elevated range would demonstrate positive study results.
Measured: minimum 20 weeks, up to 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2020
- Study startJan 2020 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionJul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Executive FunctioningStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- One single group of 30 pediatric participants will undergo 20 sessions of traditional occupational therapy services while receiving EEG neurofeedback within each session. Standardized assessment will be administered at the beginning of the session and at the end of 20 sessions to compare differences between executive functioning skills.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northern Arizona University
- Sponsor type
- University, hospital or other
- Collaborators
- Kidabilities Occupational Therapy Clinic
- Responsible party
- Principal investigator, Lauren Hall, Northern Arizona University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04221620
- Sponsor's protocol ID
- northernAU
- Status last verified
- Jan 2020
- First submitted
- 12 Dec 2019
- Last updated
- 9 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: Currently no plans to make individual participant data available. If plans change, all information will be de-identifiable and unable to be traced to specific participants.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of EEG Neurofeedback in Pediatric Occupational Therapy to Improve Executive Functioning
- ClinicalTrials.gov ID
- NCT04221620
- Acronym / sponsor ID
- northernAU
- Conditions
- Executive Functioning, Pediatric ALL
- Keywords
- EEG neurofeedback, occupational therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Northern Arizona UniversityUniversity, hospital or other
- Collaborators
- Kidabilities Occupational Therapy Clinic
- Study start
- Jan 2020 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Jul 2021 (estimated)
- First posted
- 9 Jan 2020 (actual)
- 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.
EEG Neurofeedback is a noninvasive way that allows the central nervous system to self regulate and the frontal cortex to be accessed through quieting of the limbic system at the subcortical level. Currently there is limited research in regards to the implications of EEG Neurofeedback, however, the investigators of this study have been using EEG Neurofeedback as a passive modality in the treatment of various pediatric clients with a variety of diagnoses and disorders. The purpose of this study is to determine whether or not EEG neurofeedback is effective in improving executive functioning skills in pediatric, school aged children as a modality in traditional occupational therapy services. The investigators hypothesize that EEG neurofeedback will assist with improved sensory gating abilities, therefore allowing for higher levels of cognition and awareness due to increased opportunities for the brain to regulate itself.
Detailed description
Electroencephalogram (EEG) Neurofeedback is a noninvasive way to allow the central nervous system to self regulate and calm the brain enough to allow the frontal cortex to function in an ideal state, which is the part of the brain that controls important functions including behavior, problem solving, memory, language, emotions, and judgment. There is limited research in regards to the use of EEG Neurofeedback, however, occupational therapists Cat Young and Lauren Hall have been using EEG Neurofeedback alongside traditional therapy as 'background noise' with pediatric clients. These therapists have observed children experience steady increases in speech and language abilities, self-care tasks such as becoming potty trained, and better abilities to understand self-regulation of emotions with EEG Neurofeedback when used together with traditional occupational therapy services. EEG Neurofeedback is performed via a musical medley that lasts for about 34 minutes, with baseline numbers taken at the beginning and after the music finishes. During this time, the participant will wear headphones, sensory clips on the ears (3 total), and two sensors on their head.
The purpose of this study is to test the effectiveness of EEG Neurofeedback in improving executive functioning skills in pediatric school aged children. The investigators hypothesize is that the EEG Neurofeedback will allow the body to filter out unnecessary information and white noise to focus on the task at hand, and therefore access higher levels of cognition and awareness by helping the brain to regulate itself. This study does not require additional time outside of the therapy session. Some of these clients already received treatment in therapy. The purpose of this consent form is to use the data gained from the client's BRIEF-2 scores and therapy sessions to test effectiveness of this device.
Furthermore, the purpose of the study is to determine potential benefits of using EEG Neurofeedback alongside traditional occupational therapy in improving executive functioning skills in school aged children. Requirements include children who experience impairments based on scores of potentially clinically elevated or clinically elevated levels on the Behavior Rating Inventory of Executive Function 2, or the BRIEF-2. This assessment is considered the gold standard for testing executive functioning and has over 1000 peer reviewed articles. At time of evaluation, the parent(s) or legal caregiver(s) will be given one (1) BRIEF-2 parental rating scale, which will take an average of 10-15 minutes to complete. Each question will be answered via a three point scale for whether they see the specific behavior often, sometimes, or never. Potential benefits include improved ability to stay on task, organize and complete tasks. There is minimal risk associated with the use of EEG Neurofeedback. Children might experience discomfort with the sensors placed on their head and attached to their ears. Some children might initially feel uncomfortable with the experience of being a relaxed alert state if they are prone to being in heightened alert states.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- One single group of 30 pediatric participants will undergo 20 sessions of traditional occupational therapy services while receiving EEG neurofeedback within each session. Standardized assessment will be administered at the beginning of the session and at the end of 20 sessions to compare differences between executive functioning skills.
| Arm | Type | Receives |
|---|---|---|
| EEG neurofeedback | Experimental | Device: Zengar Electroencephalogram (EEG) Neurofeedback deviceAll participants will receive 20 sessions of traditional occupational therapy services while receiving EEG neurofeedback. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- school aged children: ages 6 to 18 years old.
- score of 4 out of 9 on the BRIEF-2 assessment, indicating a potentially clinically elevated or clinically elevated need for therapeutic intervention
Key exclusion criteria (3 listed)
- score of 3 or less of the 9 categories on the BRIEF
- ratings that are equal to or higher than 7 on the inconsistency scale (indicating parent/caregiver bias)
- age requirements not met
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 |
|---|---|---|
| Zengar Electroencephalogram (EEG) Neurofeedback deviceElectroencephalogram (EEG) Neurofeedback is a noninvasive way to allow the central nervous system to self regulate and calm the brain enough to allow the frontal cortex to function in an ideal state, which is the part of the brain that controls important functions including behavior, problem solving, memory, language, emotions, and judgment. EEG Neurofeedback is performed via a musical medley that lasts for about 34 minutes, with baseline numbers taken at the beginning and after the music finishes. During this time, the participant will wear headphones, sensory clips on the ears (3 total), and two sensors on their head while receiving traditional occupational therapy services. | Device | EEG neurofeedback |
Primary outcome
Executive functioning improvements
Time frame: minimum 20 weeks, up to 8 months
Executive functioning improvements as indicated by improved scores on the Behavior Rating Inventory of Executive Functioning second edition, or BRIEF-2, at the end of 20 sessions when EEG neurofeedback was utilized. The BRIEF-2 is considered the gold standard for testing executive functioning and has over 1000 peer reviewed articles. It utilizes three different scoring sub-sections- typical, potentially clinically elevated. or clinically elevated. Participants in this study must score within the potentially clinically elevated or clinically elevated levels to qualify. Ideally, moving up one section to typical range or potentially elevated range would demonstrate positive study results.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2020.
- Individual participant dataSharing planned: Undecided. Currently no plans to make individual participant data available. If plans change, all information will be de-identifiable and unable to be traced to specific participants.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zengar Electroencephalogram (EEG) Neurofeedback device in people with Executive Functioning and Pediatric ALL, run by Northern Arizona University 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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 9 Jan 2020. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lauren Hall, OTD (6236060883, LaurenHallOTD@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Executive functioning improvements (time frame: minimum 20 weeks, up to 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jan 2020.