NCT04871009

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: University of Rochester · Academic / Other
• Sex: All
• Age: 6 Years – 12 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-02-28
• Primary completion: 2025-08-01
• Completion: 2025-08-01
• First posted: 2021-05-04
• Last updated: 2026-01-09

Locations

1 site across 1 country: United States