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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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
~3680

Find a Location

Who is running the clinical trial?

University of RochesterLead Sponsor
842 Previous Clinical Trials
534,017 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Would I be able to enroll in this clinical experiment?

"This investigation is seeking out 40 minors within the ages of 6 and 12, who have endured a traumatic experience. In addition to these requirements, participants must be: cared for by an adult guardian; receiving or eligible to receive trauma-focused cognitive behavior therapy or another form of trauma-related counseling determined by their principal therapist; possess a mobile device with Bluetooth technology that can run either Apple's iOS software or Android OS compatible with MUSE Calm app and its pertaining neurofeedback wearable accessory."

Answered by AI

How many individuals are being studied in this research trial?

"Affirmative. Clinicaltrials.gov attests that this research endeavor, which was inaugurated on February 28th 2022, is currently welcoming volunteers to take part in the study. There are 40 participants needed from one medical center."

Answered by AI

Is the enrollment window for this experiment still open?

"According to recent updates on clinicaltrials.gov, this medical trial is actively gathering participants. The initial posting was made on February 28th 2022 and a subsequent update was posted in November 28th 2022."

Answered by AI

What end-goals are being targeted by this medical research?

"The primary result of this trial, evaluated over baseline to 3 months, will be the mean change in Patient-Reported Outcomes Measurement Information System Pediatric Item Bank v2.0 - Anxiety - Short Form 8a (PROMIS). Additionally, researchers are gauging Mean number of sessions per week and duration thereof; satisfaction with intervention on a 5 point scale ranging from "Very Dissatisfied" to "Very Satisfied"; as well as the mean period for each session."

Answered by AI

Is it possible for individuals under the age of 35 to participate in this experiment?

"This medical trial is exclusively available to individuals between the ages of 6 and 12. Separately, there are 11 trials for children under 18 years old, as well as 50 studies targeting senior citizens above 65."

Answered by AI

Who else is applying?

What state do they live in?
New York
How old are they?
18 - 65
What site did they apply to?
University of Rochester Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Trial of Neurofeedback as an Adjunctive Treatment for Youth in Outpatient Mental Health Settings
Thomas O'Connor 2022. "A Trial of Neurofeedback as an Adjunctive Treatment for Youth in Outpatient Mental Health Settings". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04871009.
All > Mental Health
~3 spots leftby Aug 2024
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