A Trial of Neurofeedback as an Adjunctive Treatment for Youth in Outpatient Mental Health Settings

NCT ID: NCT04871009

Last Updated: 2026-01-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-28
• Study Completion Date: 2025-08-01

Brief Summary

The purpose of this study is to test the feasibility and effectiveness of a neurofeedback intervention conducted as an adjunctive behavioral health treatment to reduce trauma and affective symptoms in trauma-exposed youth.

Conditions

Trauma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard of Care

routine clinical psychotherapy

Group Type: PLACEBO_COMPARATOR

standard of care

Intervention Type: BEHAVIORAL

trauma focused cognitive behavioral therapy or other behavioral therapy at the discretion of therapist

Neurofeedback Intervention plus standard of care

routine clinical psychotherapy plus 3 to 4 neurofeedback interventions per week.

Group Type: EXPERIMENTAL

Neurofeedback Intervention

Intervention Type: BEHAVIORAL

InteraXon, Inc. produces the MUSE 2 wearable neurofeedback device and mobile application (heretofore referred to as the "MUSE app"), respectively comprising the electroencephalogram (EEG) hardware and interactive software components that will be used in this intervention. The MUSE 2 is an adjustable headband that is placed across the forehead and over and behind the ears. It contains EEG sensors for active sites across the forehead and behind the ears, and an additional reference site behind the ear. These sensors use EEG technology to passively record children's brainwaves. During a session, caregivers will help children place the MUSE 2 on their heads and connect it to the app on their personal device. Children's brain activity is recorded by the MUSE 2 and is represented on the app through audio-based feedback that children will listen to with earbuds, and use their volition to influence in real time, with the goal of gaining increased control over their own brain activity.

standard of care

Intervention Type: BEHAVIORAL

trauma focused cognitive behavioral therapy or other behavioral therapy at the discretion of therapist

Interventions

Neurofeedback Intervention

InteraXon, Inc. produces the MUSE 2 wearable neurofeedback device and mobile application (heretofore referred to as the "MUSE app"), respectively comprising the electroencephalogram (EEG) hardware and interactive software components that will be used in this intervention. The MUSE 2 is an adjustable headband that is placed across the forehead and over and behind the ears. It contains EEG sensors for active sites across the forehead and behind the ears, and an additional reference site behind the ear. These sensors use EEG technology to passively record children's brainwaves. During a session, caregivers will help children place the MUSE 2 on their heads and connect it to the app on their personal device. Children's brain activity is recorded by the MUSE 2 and is represented on the app through audio-based feedback that children will listen to with earbuds, and use their volition to influence in real time, with the goal of gaining increased control over their own brain activity.

Intervention Type: BEHAVIORAL

standard of care

trauma focused cognitive behavioral therapy or other behavioral therapy at the discretion of therapist

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

(children)

• caregiver-reported exposure to two or more ACE types on the ACE-Q-Child measure.
• ages of 6-12 years old
• receiving or eligible to receive trauma-focused cognitive behavior therapy or another type of trauma-focused therapy, as determined by their primary therapist, designated as the TAU condition
• speaks and reads English

(caregivers)

• own an iPhone, iPad, smartphone, or tablet that is equipped with Bluetooth and uses an Apple or Android operating system that is compatible with the MUSE Calm app and accompanying MUSE wearable neurofeedback device
• speaks and read English

Exclusion Criteria

Child-caregiver dyads will be excluded if

• the child falls outside of the required age range,
• has a documented history of epilepsy
• is currently considered to be at high risk for suicide attempt
• is currently experiencing psychosis

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Rochester

OTHER

Sponsor Role: lead

Responsible Party

Thomas O'Connor

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Rochester Medical Center

Rochester, New York, United States

Countries

United States

Other Identifiers

STUDY00006013

Identifier Type: -

Identifier Source: org_study_id