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Behavioral Intervention

Neurofeedback for Healthy Emotion Regulation in Youth

N/A
Recruiting
Led By Kara L Kerr, PhD
Research Sponsored by Oklahoma State University Center for Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Biological female
Body mass index between 16 and 40 (inclusive) (adolescents)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one year (change from first scan session to one-year follow-up)
Awards & highlights

Study Summary

This trial will study how a mom and daughter's brain activity changes when they view each other's real-time fMRI results while talking.

Who is the study for?
This trial is for biological female mother-daughter pairs, where the daughter is aged 14-17 and has experienced at least two adverse childhood events. They must live together most of the week, speak English well enough to do tasks, and both be eligible for fMRI scans. Those with psychiatric disorders, neurodevelopmental delays or on medications that affect fMRI cannot participate.Check my eligibility
What is being tested?
The study tests a new way to help young girls manage their emotions using real-time brain activity feedback (neurofeedback). Mothers will see their daughters' brain signals while talking to them and try to influence these signals positively.See study design
What are the potential side effects?
Since this trial involves non-invasive neurofeedback through an fMRI scan without drugs or medical procedures, side effects are minimal but may include discomfort from staying still in the scanner and potential anxiety from being in a confined space.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a biological female.
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My BMI is between 16 and 40.
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I am between 14 and 17 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one year (change from first scan session to one-year follow-up)
This trial's timeline: 3 weeks for screening, Varies for treatment, and one year (change from first scan session to one-year follow-up) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Brain
Resting-state network activity
Secondary outcome measures
Affect variability (change over time)
Depressive Symptoms
Emotion regulation (change over time)
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Neurofeedback GroupExperimental Treatment1 Intervention
Mothers of adolescent participants will view real-time fMRI neurofeedback representing activity in their daughter's anterior insula during an emotion discussion task. Activity will be presented as a colored bar of moving height, and mothers will be instructed to attempt to downregulate the activity through what they say to their daughter.
Group II: Control GroupActive Control1 Intervention
The paradigm for the control condition will be identical to that of the experimental condition except that no neurofeedback will be presented. Participants in the control group will be told that we would like to see if the mother can regulate her daughter's brain activity through supportive statements.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Neurofeedback
2019
Completed Phase 3
~1010

Find a Location

Who is running the clinical trial?

Oklahoma State University Center for Health SciencesLead Sponsor
35 Previous Clinical Trials
5,046 Total Patients Enrolled
Kara L Kerr, PhDPrincipal InvestigatorOklahoma State University
1 Previous Clinical Trials
42 Total Patients Enrolled

Media Library

Neurofeedback (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05472545 — N/A
Emotional Regulation Research Study Groups: Control Group, Neurofeedback Group
Emotional Regulation Clinical Trial 2023: Neurofeedback Highlights & Side Effects. Trial Name: NCT05472545 — N/A
Neurofeedback (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05472545 — N/A

Frequently Asked Questions

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

What is the primary purpose of this clinical research study?

"This clinical trial has identified Resting-state network activity as its primary outcome, to be assessed within a one hour timeframe. The secondary outcomes include shifts in the PROMIS Pediatric Short Form Version 2 scores (to assess changes in depressive symptoms), alterations in Difficulties of Emotion Regulation Scale ratings (for evaluating emotion regulation) and fluctuations in affect variability via ecological momentary assessment measures over two weeks."

Answered by AI

Is enrollment for this clinical experiment currently open?

"This trial, initially posted on September 1st 2022 and last updated July 21st of the same year is no longer enrolling participants. Nonetheless, there are 8 other trials that currently require volunteers to participate.."

Answered by AI
~109 spots leftby Jun 2025