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Neurofeedback for Youth Trauma

N/A
Recruiting
Research Sponsored by University of Rochester
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ages of 6-12 years old
(children)
Must not have
has a documented history of epilepsy
is currently experiencing psychosis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months

Summary

This trialtests if a therapy that uses brain activity feedback can help reduce trauma & emotions in young people who have experienced trauma.

Who is the study for?
This trial is for children aged 6-12 who have experienced trauma and are receiving or eligible for trauma-focused therapy. They must have a caregiver, speak English, and own a device compatible with the MUSE Calm app. Children at high risk of suicide, experiencing psychosis, or with epilepsy cannot participate.
What is being tested?
The study is examining if neurofeedback can help reduce symptoms in traumatized youth when added to standard care. Participants will use the MUSE wearable device alongside their usual therapy to see if it improves outcomes.
What are the potential side effects?
Since this trial involves non-invasive neurofeedback as an addition to standard therapy, there may be minimal side effects; however, specifics aren't provided here. Standard care side effects depend on the individual treatments received.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 6 and 12 years old.
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I am a child.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a documented history of epilepsy.
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I am currently experiencing psychosis.
Select...
My child does not meet the age requirement for the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Mean change in Patient Reported Outcomes Measurement Information System Pediatric Item Bank v2.0 - Anxiety - Short Form 8a (PROMIS)
Mean change in Short Mood and Feelings Questionnaire (SMFQ)
Mean change in Trauma Symptom Checklist for Young Children (TSCYC)
Secondary study objectives
Mean change in Beck Depression Inventory II (BDI-II)
Mean number of sessions per week
Mean satisfaction with the intervention
+4 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Neurofeedback Intervention plus standard of careExperimental Treatment2 Interventions
routine clinical psychotherapy plus 3 to 4 neurofeedback interventions per week.
Group II: Standard of CarePlacebo Group1 Intervention
routine clinical psychotherapy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
standard of care
2008
Completed Phase 4
~3640

Find a Location

Who is running the clinical trial?

University of RochesterLead Sponsor
869 Previous Clinical Trials
549,722 Total Patients Enrolled
~8 spots leftby Aug 2025
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