Neurofeedback for Healthy Emotion Regulation in Youth

Recruiting in Tulsa (>99 mi)

Overseen By Kara L Kerr, PhD

Age: Any Age

Sex: Female

Trial Phase: Academic

Sponsor: Oklahoma State University Center for Health Sciences

Must not be taking: fMRI-influencing medications

Disqualifiers: Psychiatric disorder, Neurodevelopmental delay, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: One hour per session

210 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that adolescent participants do not take medications that influence fMRI. If you are on such medications, you may need to stop taking them to participate.

What data supports the effectiveness of the treatment Neurofeedback for Healthy Emotion Regulation in Youth?

Research shows that neurofeedback, which involves training the brain to self-regulate, has been used successfully to help with attention issues in ADHD and emotional regulation in depression. Studies have demonstrated that combining EEG and fMRI neurofeedback can help individuals control brain activity related to emotions, suggesting potential benefits for emotional regulation in youth. ^{1 2 3 4 5}

Is neurofeedback safe for children and adolescents?

Research on neurofeedback, including EEG and fMRI methods, suggests it is generally safe for children and adolescents, with studies conducted on conditions like ADHD and anxiety showing no significant safety concerns. ^{1 3 4 6 7}

How is neurofeedback treatment unique for emotion regulation in youth?

Neurofeedback is unique because it uses real-time brain activity feedback, often through EEG or fMRI, to help individuals learn to self-regulate their brain functions, which can improve emotion regulation. This approach is non-invasive and leverages the brain's ability to change and adapt, known as neuroplasticity, making it different from traditional medication-based treatments. ^{1 3 5 8 9}

What is the purpose of this trial?

This study will examine the effect of a real-time functional magnetic resonance imaging (fMRI) dyadic neurofeedback protocol with mothers and their adolescent daughters. Mothers in the experimental condition will view a moving bar showing their daughters' brain activity on a computer screen while talking to their daughters.

Research Team

Kara L Kerr, PhD

Principal Investigator

Oklahoma State University

Eligibility Criteria

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.

Inclusion Criteria

Sufficient English fluency to complete tasks

I am a biological female.

Primary caregiver for more than 50% of child's lifespan (adult participants)

Exclusion Criteria

I am a teenager with a developmental delay.

Current or past psychiatric disorder (adolescent participants)

I am a teenager with no conditions that affect brain scans.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo real-time fMRI dyadic neurofeedback sessions with their mothers, focusing on emotion regulation tasks

One hour per session

1 visit (in-person)

Follow-up

Participants are monitored for changes in depressive symptoms, parenting behaviors, and emotion regulation over time

One year

Ecological Momentary Assessment

Adolescents complete EMA measures multiple times per day over two weeks to assess affect variability and parent-adolescent interaction quality

Two weeks

Treatment Details

Interventions

• Neurofeedback

Trial Overview 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.

Participant Groups

Group I: Neurofeedback Group Experimental Treatment 1 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 Group Active Control 1 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.

Neurofeedback is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Neurofeedback for:

• Chronic low back pain
• Fibromyalgia
• Neuropathic pain

Approved in European Union as Neurofeedback for:

• Chronic pain
• Fibromyalgia
• Neuropathic pain

Approved in Canada as Neurofeedback for:

• Chronic pain
• Fibromyalgia

Who Is Running the Clinical Trial?

Oklahoma State University Center for Health Sciences

Lead Sponsor

Trials

37

Recruited

4,900+

Findings from Research

Neurofeedback, including techniques like surface neurofeedback and advanced methods such as real-time z-score neurofeedback, shows promise in treating conditions like anxiety, mood disorders, and traumatic brain injury, particularly in children and adolescents.

The article emphasizes the need for more randomized controlled studies to establish effective clinical guidelines and to identify which patients may benefit most from neurofeedback interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quantitative EEG and neurofeedback in children and adolescents: anxiety disorders, depressive disorders, comorbid addiction and attention-deficit/hyperactivity disorder, and brain injury. Simkin, DR., Thatcher, RW., Lubar, J.[2015]

A structured neurofeedback training program using electroencephalography showed some positive effects on attentional performance in 24 children and adolescents with ADHD, particularly in reducing reaction times in attention tasks after 20 sessions.

While the results indicated improvements in attention, the effects were generally small and preliminary, highlighting the need for larger studies with control groups to better assess the efficacy of this intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a structured 20-session slow-cortical-potential-based neurofeedback program on attentional performance in children and adolescents with attention-deficit hyperactivity disorder: retrospective analysis of an open-label pilot-approach and 6-month follow-up. Albrecht, JS., Bubenzer-Busch, S., Gallien, A., et al.[2020]

The study successfully implemented the first simultaneous neurofeedback system using both real-time functional MRI (rtfMRI) and EEG, allowing participants to regulate brain activity related to emotional self-regulation.

Participants were able to control their brain activation in the left amygdala and adjust EEG power, indicating the potential of this combined approach for developing new therapies for mental disorders like depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-regulation of human brain activity using simultaneous real-time fMRI and EEG neurofeedback. Zotev, V., Phillips, R., Yuan, H., et al.[2013]

In a study involving 144 children aged 7 to 10 with moderate to severe ADHD, theta/beta-ratio neurofeedback (NF) did not show a significant advantage over a control treatment in reducing inattention, with both groups improving similarly over time.

While both groups reported improvements, the NF group required significantly less medication at the 13-month follow-up, suggesting a potential benefit in medication management, even though the specific efficacy of NF was not established.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Double-Blind Placebo-Controlled Randomized Clinical Trial of Neurofeedback for Attention-Deficit/Hyperactivity Disorder With 13-Month Follow-up. [2022]

Real-time fMRI can help patients learn to self-regulate brain circuits related to emotion and depression, showing promise as a new approach to treating affective disorders.

Initial results from fMRI-based neurofeedback (fMRI-NF) in depression are encouraging, but further clinical trials are needed to establish its efficacy and to develop practical applications for everyday use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurofeedback and networks of depression. Linden, DE.[2021]

In a study involving 41 children with ADHD, EEG neurofeedback did not show a significant improvement in ADHD symptoms compared to placebo neurofeedback, indicating it may not be an effective treatment option.

Both treatment groups experienced a general improvement in ADHD symptoms over time, but there were no significant differences between the groups, and no clinically relevant side effects were reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized placebo-controlled trial of electroencephalographic (EEG) neurofeedback in children with attention-deficit/hyperactivity disorder. van Dongen-Boomsma, M., Vollebregt, MA., Slaats-Willemse, D., et al.[2015]

A new two-channel EEG headband was developed that is safe, easy to attach and remove, and does not require electrode paste, making it suitable for frequent use in monitoring neurodevelopment.

Preliminary tests with a visual neurofeedback game showed age-dependent changes in brain wave activity among 30 children aged 5 to 20, suggesting potential for using this device in educational and neurocognitive development applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Simplified Attachable EEG Revealed Child Development Dependent Neurofeedback Brain Acute Activities in Comparison with Visual Numerical Discrimination Task and Resting. Oda, K., Colman, R., Koshiba, M.[2022]

Functional magnetic resonance imaging (fMRI)-based neurofeedback shows promise in helping adolescents gain control over their emotion regulation brain networks, which are still developing during this critical period.

Studies indicate that this neurofeedback approach can enhance effective emotion regulation abilities in children and adolescents, potentially aiding in the treatment of social anxiety disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Training the anxious brain: using fMRI-based neurofeedback to change brain activity in adolescence. Lipp, A., Cohen Kadosh, K.[2021]

A novel neurofeedback protocol was tested on 34 depressed and 19 healthy adolescents, showing that neurofeedback can enhance brain activity in regions related to self-processing and emotion regulation, particularly the amygdala and hippocampus.

The study found that while depressed adolescents had different brain activity patterns compared to healthy controls during neurofeedback, the training successfully engaged brain circuits that could potentially improve emotional regulation and self-recognition in adolescents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurofeedback and neuroplasticity of visual self-processing in depressed and healthy adolescents: A preliminary study. Quevedo, K., Liu, G., Teoh, JY., et al.[2020]

References

1. United States pubmed.ncbi.nlm.nih.gov

Quantitative EEG and neurofeedback in children and adolescents: anxiety disorders, depressive disorders, comorbid addiction and attention-deficit/hyperactivity disorder, and brain injury. [2015]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Effects of a structured 20-session slow-cortical-potential-based neurofeedback program on attentional performance in children and adolescents with attention-deficit hyperactivity disorder: retrospective analysis of an open-label pilot-approach and 6-month follow-up. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Self-regulation of human brain activity using simultaneous real-time fMRI and EEG neurofeedback. [2013]

4. United States pubmed.ncbi.nlm.nih.gov

Double-Blind Placebo-Controlled Randomized Clinical Trial of Neurofeedback for Attention-Deficit/Hyperactivity Disorder With 13-Month Follow-up. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Neurofeedback and networks of depression. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

A randomized placebo-controlled trial of electroencephalographic (EEG) neurofeedback in children with attention-deficit/hyperactivity disorder. [2015]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Simplified Attachable EEG Revealed Child Development Dependent Neurofeedback Brain Acute Activities in Comparison with Visual Numerical Discrimination Task and Resting. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Training the anxious brain: using fMRI-based neurofeedback to change brain activity in adolescence. [2021]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Neurofeedback and neuroplasticity of visual self-processing in depressed and healthy adolescents: A preliminary study. [2020]