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Neurofeedback Intervention for Trauma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Rochester Medical Center, Rochester, NYTraumaNeurofeedback Intervention - Behavioral
Eligibility
6 - 12
All Sexes
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Study Summary

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

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

3 Primary · 7 Secondary · Reporting Duration: 3 months

3 months
Mean number of sessions per week
Mean satisfaction with the intervention
mean length of each session
Baseline to 3 months
Parental Stress Scale (PSS)
baseline to 3 months
Mean change in Beck Depression Inventory II (BDI-II)
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)
Number of caregivers reporting childhood trauma
post traumatic stress disorder (PTSD) Checklist for DSM-5 (PCL-5)

Trial Safety

Safety Progress

1 of 3

Similar Trials

1
Flotation therapy sensory deprivation tank
1
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1
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Trial Design

2 Treatment Groups

Neurofeedback Intervention plus standard of care
1 of 2
Standard of Care
1 of 2

Experimental Treatment

Non-Treatment Group

40 Total Participants · 2 Treatment Groups

Primary Treatment: Neurofeedback Intervention · Has Placebo Group · N/A

Neurofeedback Intervention plus standard of careExperimental Group · 2 Interventions: Neurofeedback Intervention, standard of care · Intervention Types: Behavioral, Behavioral
Standard of Care
Behavioral
PlaceboComparator Group · 1 Intervention: standard of care · Intervention Types: Behavioral
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
standard of care
2008
Completed Phase 4
~4020

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 3 months

Who is running the clinical trial?

University of RochesterLead Sponsor
799 Previous Clinical Trials
505,828 Total Patients Enrolled

Eligibility Criteria

Age 6 - 12 · All Participants · 8 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
The clinical trial is not open for participation by children.
The caregiver has reported that the child has experienced multiple adverse childhood experiences (ACEs) on a questionnaire.
You are between 6 and 12 years old.
You must have either an iPhone, iPad, smartphone, or tablet with Bluetooth capability and an Apple or Android operating system that can use the MUSE Calm app and MUSE wearable neurofeedback device.
You are currently undergoing or eligible to undergo a type of therapy called trauma-focused cognitive behavior therapy or another similar therapy for trauma.

Who else is applying?

What state do they live in?
New York100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
University of Rochester Medical Center100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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