Effectiveness of EEG Neurofeedback in Pediatric Occupational Therapy to Improve Executive Functioning

Pediatric ALL Clinical Trial

Official title:

Effectiveness of EEG Neurofeedback in Pediatric Occupational Therapy to Improve Executive Functioning

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04221620
• Other study ID #: northernAU
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2020
• Est. completion date: July 2021

Study information

• Verified date: January 2020
• Source: Northern Arizona University
• Contact: Lauren Hall, OTD
• Phone: 6236060883
• Email: LaurenHallOTD[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: July 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Executive Functioning
• Pediatric ALL

Intervention

Device:
• Zengar Electroencephalogram (EEG) Neurofeedback device
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.

Locations

Country	Name	City	State
United States	Kidabilities Occupational Therapy	Prescott	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Northern Arizona University	Kidabilities Occupational Therapy Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	minimum 20 weeks, up to 8 months