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Search / Trial NCT04871009

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

Launched by UNIVERSITY OF ROCHESTER · Apr 28, 2021

Trial Information

Current as of November 11, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is looking at a treatment called neurofeedback to help children and teenagers who have experienced trauma. Neurofeedback is a method that uses real-time monitoring of brain activity to help improve mental health. The goal of the study is to see if this treatment can effectively reduce symptoms related to trauma when used alongside other therapies, like trauma-focused cognitive behavioral therapy.

To participate, children aged 6 to 12 who have faced multiple types of adverse childhood experiences (like abuse or neglect) may be eligible, as long as they are receiving or can receive trauma-focused therapy. Their caregivers must have a smartphone or tablet that can work with a special app and device used in the study. Participants will receive neurofeedback sessions as part of their treatment and will be monitored throughout the trial. It's important to note that children with certain conditions, like a history of epilepsy or severe mental health issues, won't be able to join the study to ensure everyone's safety.

Gender

ALL

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

About University Of Rochester

The University of Rochester is a leading academic institution dedicated to advancing medical research and improving patient care through innovative clinical trials. Renowned for its commitment to excellence in education, research, and clinical practice, the university fosters a collaborative environment that integrates cutting-edge scientific inquiry with practical applications in healthcare. With a focus on diverse therapeutic areas, the University of Rochester aims to enhance treatment options and outcomes for patients while contributing to the broader scientific community through rigorous study design and ethical standards in clinical research.

Locations

Rochester, New York, United States

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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