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

NCT04221620 | Unknown FDA Device

• 1 other identifier: northernAU
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Executive Functioning; Pediatric ALL

Keywords

EEG neurofeedback; occupational therapy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

EEG neurofeedback

EXPERIMENTAL

All participants will receive 20 sessions of traditional occupational therapy services while receiving EEG neurofeedback.

Device: Zengar Electroencephalogram (EEG) Neurofeedback device

Interventions

Zengar Electroencephalogram (EEG) Neurofeedback device 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.

EEG neurofeedback

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northern Arizona University: lead
• Kidabilities Occupational Therapy Clinic: collaborator

Study Sites (1)

Kidabilities Occupational Therapy

Prescott, Arizona, 86305, United States

Location

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Electroencephalography

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Neurological; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis

Central Study Contacts

Lauren Hall, OTD

CONTACT

6236060883; LaurenHallOTD@gmail.com

Catherine Young, MOT

CONTACT

9286428747; Catherine_young_@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Co-PI Catherine Young will be completing all evaluations and de-indentification of study participants. I (Lauren Hall) will be working with the de-identified data.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor of Occupational Therapy

Model Details: 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.

Study Record Dates

• First Submitted: December 12, 2019
• First Posted: January 9, 2020
• Study Start: January 1, 2020
• Primary Completion: December 1, 2020
• Study Completion: July 1, 2021
• Last Updated: January 9, 2020

Record last verified: 2020-01

Locations

US (1)