Neurofeedback Training for Maternal Distress

Overseen By Principal Investigator

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Wayne State University

Must not be taking: Benzodiazepines, Narcotics, Cannabis

Disqualifiers: Pregnancy, Untreated mental illness, Epilepsy, 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: Unknown

20 Participants Needed

Trial Summary

What is the purpose of this trial?

The proposed study will collect novel data evaluating the feasibility of the NFB training program delivered in an outpatient mental health setting and its influence on mothers' overall sense of well-being, and further investigate whether enhanced well-being is associated with positive changes in emotion regulation capacities, trauma-related mental health symptoms, parenting behaviors and attitudes, and infant behavioral outcomes (i.e., crying, fussing) among postpartum mothers with a history of childhood trauma and clinically concerning trauma-related mental health symptoms.

Will I have to stop taking my current medications?

The trial requires that participants are not currently taking benzodiazepines, narcotic drugs, or cannabis, and have not taken them in the past month. If you are taking these medications, you would need to stop before participating.

What data supports the effectiveness of the treatment Neuroptimal Neurofeedback for maternal distress?

Research shows that neurofeedback, a treatment that helps people learn to control their brain activity, has been effective for various conditions like PTSD and alcohol use disorder. It can improve symptoms like anxiety and depression by enhancing cognitive control, and it generally has no significant side effects. ^{1 2 3 4 5}

Is neurofeedback generally safe for humans?

The safety of neurofeedback has not been thoroughly investigated, but clinical experience suggests it is reasonably safe. ^{2 6 7 8 9}

How does neurofeedback training differ from other treatments for maternal distress?

Neurofeedback training is unique because it focuses on helping mothers regulate their brain activity to manage stress and emotional responses, rather than relying on medication or traditional therapy. This approach leverages the brain's ability to adapt and change, potentially offering a non-invasive and personalized way to address maternal distress. ^{10 11 12 13 14}

Eligibility Criteria

This trial is for postpartum mothers within 3-24 months after giving birth, who are experiencing significant PTSD symptoms or dissociation. Participants must be undergoing regular in-person psychotherapy in the Greater Detroit area.

Inclusion Criteria

I show signs of PTSD or its dissociative subtype based on recent screenings.

I gave birth between 3 to 24 months ago.

I am currently seeing a therapist in person in the Greater Detroit area.

Exclusion Criteria

Have ever experienced previous head injury with loss of consciousness

Are currently pregnant

I have a documented history of epilepsy.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Neurofeedback Training

Participants undergo a neurofeedback training program to enhance wellness, with pre and post-training assessments

3 months

Weekly sessions

Follow-up

Participants are monitored for changes in trauma symptoms, mental health, and parenting behaviors after the training phase

4 weeks

Treatment Details

Interventions

• Neuroptimal Neurofeedback

Trial Overview The study tests a Neurofeedback training program (Neuroptimal) to see if it can improve well-being, emotional regulation, reduce trauma-related mental health issues, and positively affect parenting behaviors and infant behavior among trauma-exposed mothers.

Participant Groups

Group I: Neurofeedback Training Experimental Treatment 1 Intervention

Mothers in the Neurofeedback Training group will complete pre and post-training self-report surveys assessing trauma symptoms, mental health, parenting attitudes and behaviors, and infant crying patterns and socioemotional development. Mothers in this group will all be receiving in-person psychotherapy outside of the study, and they will all demonstrate clinically significant symptoms aligned with post-traumatic stress disorder and/or it's dissociative subtype.

Who Is Running the Clinical Trial?

Wayne State University

Lead Sponsor

Trials

318

Recruited

111,000+

Findings from Research

A pilot study involving 16 specialists showed that using EEG-based neurofeedback to control the loudness of music significantly reduced stress and improved mental and emotional well-being compared to simply listening to music.

The method demonstrated the potential for personalized music therapy, as it tailored the music experience to the individual's EEG signals, leading to more effective stress management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stress Coping Via Musical Neurofeedback. Alexander, F.[2022]

Neurofeedback (NF) training has shown promising results in improving attention and memory in both healthy individuals and patients, particularly children with ADHD, who demonstrated behavioral and cognitive improvements after specific training methods.

For drug-resistant epilepsy patients, NF training has led to significant and lasting reductions in seizure frequency and intensity, indicating its potential as a valuable treatment option in neuropsychiatric disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Annotation: neurofeedback - train your brain to train behaviour. Heinrich, H., Gevensleben, H., Strehl, U.[2009]

Neurofeedback therapy, which uses real-time feedback on brainwaves to promote self-regulation, shows promise in treating psychiatric disorders, including alcohol dependence, with the potential for long-term benefits due to neural plasticity.

This therapy has minimal side effects, primarily limited to rare temporary headaches, and can produce therapeutic effects more quickly than traditional psychotherapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurofeedback therapy for alcohol use disorder. Yamaguchi, T., Tazaki, M.[2019]

In a study involving 13 adult refugees with chronic PTSD, those who received neurofeedback combined with trauma counseling showed significantly reduced symptoms of trauma, anxiety, and depression compared to those who only received trauma counseling.

Neurofeedback therapy was associated with improved cognitive control, as indicated by increased P3 amplitude in brain activity and better performance on cognitive tasks, suggesting it may help remediate cognitive deficits in PTSD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of Neurofeedback for Posttraumatic Stress Disorder Related to Refugee Experiences Using Self-Report and Cognitive ERP Measures. Askovic, M., Watters, AJ., Coello, M., et al.[2020]

Neurofeedback is a noninvasive treatment that uses brainwave analysis to help patients with central nervous system issues, especially when traditional therapies like medication and psychotherapy are ineffective.

While there are many clinical case studies supporting the efficacy of neurofeedback, there is still a need for more controlled studies in peer-reviewed journals to further validate its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurofeedback: an emerging technology for treating central nervous system dysregulation. Larsen, S., Sherlin, L.[2013]

Neurofeedback (NF) has been explored as a treatment for various child psychiatric disorders, including ADHD, autism, learning disorders, and epilepsy, by providing real-time feedback on brain activity.

However, many studies on NF have methodological limitations, such as not using proper blinding or sham controls, and while clinical experience suggests NF is reasonably safe, its safety has not been rigorously studied in youth or adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quantitative EEG neurofeedback for the treatment of pediatric attention-deficit/hyperactivity disorder, autism spectrum disorders, learning disorders, and epilepsy. Hurt, E., Arnold, LE., Lofthouse, N.[2019]

Neurofeedback has shown positive effects in improving symptoms related to traumatic brain injury across 22 studies, indicating its potential as a treatment option.

Despite the promising results, the lack of placebo-controlled studies and standardized methodologies means that further rigorous research is needed to confirm its efficacy and establish clinical guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurofeedback and traumatic brain injury: a literature review. May, G., Benson, R., Balon, R., et al.[2022]

Neurofeedback therapy successfully reduced the high theta/beta ratio in 42 autistic children, leading to improved cognitive functions after treatment.

The therapy not only enhanced cognitive abilities but also resulted in auxiliary improvements in social skills, thought processes, and attention, suggesting a potential method for addressing cognitive impairments in autism spectrum disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of neurofeedback as a treatment modality for children in the autistic spectrum. Mekkawy, L.[2022]

A review of 15 studies on advanced neurofeedback techniques, including 19-channel Z-score neurofeedback, found no empirical evidence supporting their effectiveness or superiority over standard neurofeedback methods for treating conditions like ADHD and epilepsy.

While some evidence suggests that 3-D LORETA neurofeedback may show efficacy for ADHD and tinnitus distress, the overall quality of studies is low, and further research is needed to confirm these findings and establish any superiority.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

19 Channel Z-Score and LORETA Neurofeedback: Does the Evidence Support the Hype? Coben, R., Hammond, DC., Arns, M.[2020]

The maternal brain undergoes significant hormonal and neurobiological changes around birth, leading to reduced stress responses and anxiety, which are crucial for maternal care and offspring survival.

These adaptations are linked to increased inhibitory brain activity (like oxytocin and prolactin) and decreased excitatory pathways, highlighting their importance for both maternal mental health and the healthy development of the baby.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

No stress please! Mechanisms of stress hyporesponsiveness of the maternal brain. Slattery, DA., Neumann, ID.[2021]

The review highlights the neuroanatomical and hormonal systems, particularly opioid and dopaminergic pathways, that regulate maternal behavior, suggesting a complex interplay of brain chemistry in parenting.

It also discusses the potential for pharmacological interventions to address maternal depression, indicating that understanding these biological mechanisms could lead to effective treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The role of dopamine and opioid systems in the regulation of maternal behavior]. Dobriakova, IuV., Tanaeva, KK., Dubynin, VA., et al.[2014]

Neurobiological changes in new mothers, as shown by fMRI studies, are crucial for forming and maintaining healthy mother-infant relationships, highlighting the brain's adaptability during this period.

Factors such as birth methods, feeding practices, and hormonal changes can influence how a mother's brain adapts, while conditions like postpartum depression can lead to abnormal brain changes that may negatively affect these relationships.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The maternal brain and its plasticity in humans. Kim, P., Strathearn, L., Swain, JE.[2023]

Pregnancy and the postpartum period significantly increase the risk of developing depressive symptoms in women, affecting about 10-15% of new mothers, which can lead to impaired mother-infant interactions critical for child development.

Postpartum depression can disrupt maternal behaviors such as attachment and sensitivity, potentially resulting in adverse outcomes for children, highlighting the importance of interventions during and after pregnancy to improve maternal mental health and parenting practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postpartum depression: Etiology, treatment and consequences for maternal care. Brummelte, S., Galea, LA.[2022]

At least 1 in 7 pregnant or recently postpartum women experience mental illnesses, which can negatively impact the health of both the mother and child, highlighting the need for better understanding and treatment.

Research indicates that maternal mental illness is associated with unique neural changes, particularly in the hypothalamus, which may disrupt maternal caregiving behaviors and mother-infant interactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurobiology of peripartum mental illness. Pawluski, JL., Swain, JE., Lonstein, JS.[2023]

References

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

Stress Coping Via Musical Neurofeedback. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Annotation: neurofeedback - train your brain to train behaviour. [2009]

3. Japan pubmed.ncbi.nlm.nih.gov

Neurofeedback therapy for alcohol use disorder. [2019]

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

Evaluation of Neurofeedback for Posttraumatic Stress Disorder Related to Refugee Experiences Using Self-Report and Cognitive ERP Measures. [2020]

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

Neurofeedback: an emerging technology for treating central nervous system dysregulation. [2013]

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

Quantitative EEG neurofeedback for the treatment of pediatric attention-deficit/hyperactivity disorder, autism spectrum disorders, learning disorders, and epilepsy. [2019]

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

Neurofeedback and traumatic brain injury: a literature review. [2022]

8. Germany pubmed.ncbi.nlm.nih.gov

Efficacy of neurofeedback as a treatment modality for children in the autistic spectrum. [2022]

9. Germany pubmed.ncbi.nlm.nih.gov

19 Channel Z-Score and LORETA Neurofeedback: Does the Evidence Support the Hype? [2020]

10. England pubmed.ncbi.nlm.nih.gov

No stress please! Mechanisms of stress hyporesponsiveness of the maternal brain. [2021]

11. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[The role of dopamine and opioid systems in the regulation of maternal behavior]. [2014]

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

The maternal brain and its plasticity in humans. [2023]

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

Postpartum depression: Etiology, treatment and consequences for maternal care. [2022]

14. Netherlands pubmed.ncbi.nlm.nih.gov

Neurobiology of peripartum mental illness. [2023]