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

NCT04871009 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-01-09

No results posted yet for this study

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

Interventions

BEHAVIORAL

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.

BEHAVIORAL

standard of care

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

Sponsors & Collaborators

  • University of Rochester

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-28
Primary Completion
2025-08-01
Completion
2025-08-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04871009 on ClinicalTrials.gov