Neurofeedback for Suicide Prevention

Recruiting at 1 trial location

Overseen By Philip R Szeszko, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Must be taking: Psychotropic medications

Disqualifiers: Neurological disorders, Traumatic brain injury, Psychotic disorder, Substance use disorder, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 2 weeks

15 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help Veterans manage suicidal thoughts using a technique called real-time fMRI neurofeedback. This technique provides participants with brain activity feedback to help them learn how to reduce repetitive thoughts about suicide. Veterans experiencing these thoughts and already receiving mental health treatment may be a good fit. As an unphased trial, this study offers Veterans a unique opportunity to explore innovative treatment options.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it requires participants to be clinically stabilized on psychotropic medications. This suggests you may need to continue your current mental health medications.

What prior data suggests that this neurofeedback technique is safe for Veterans?

Research has shown that real-time fMRI neurofeedback is generally well-tolerated. One study found that using neurofeedback to target brain areas linked to suicidal thoughts is both feasible and acceptable for patients. Other studies indicate that this method can enhance brain function and behavior in individuals with various mental health conditions.

Notably, one study demonstrated that even a single session of neurofeedback can have lasting effects, helping people apply new skills in their daily lives beyond the session itself.

Overall, while additional research is always beneficial, current findings suggest that real-time fMRI neurofeedback is a safe option for many individuals. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for preventing suicide, which often involve medication and therapy, real-time fMRI neurofeedback offers a novel approach by using brain imaging to provide immediate feedback. This technique allows individuals to see their brain activity in real time, helping them to learn how to regulate it, particularly targeting the areas associated with suicide-specific rumination. Researchers are excited about this method because it empowers patients with direct control over their mental processes, potentially leading to quicker and more sustainable changes in brain patterns compared to standard therapies.

What evidence suggests that real-time fMRI neurofeedback is effective for suicide-specific rumination?

Studies have shown that real-time brain imaging can help people change brain activity linked to certain thoughts and behaviors. This technique allows individuals to see and learn to control their brain patterns as they happen. Research has found that this approach can improve brain function and behavior in people with mental health conditions. Early results from recent studies also suggest that this method can reduce repetitive negative thinking in people with depression. In this trial, all participants will receive real-time fMRI neurofeedback, which might help reduce suicidal thoughts by teaching them to manage the brain activity related to these thoughts. ^{1 2 4 6 7}

Who Is on the Research Team?

Philip R Szeszko, PhD

Principal Investigator

James J. Peters Veterans Affairs Medical Center

Are You a Good Fit for This Trial?

This trial is for Veterans experiencing mood disorders, suicidal thoughts or behaviors, and depression. It aims to help them learn strategies to manage their brain activity related to suicide-specific rumination through feedback signals.

Inclusion Criteria

I am a U.S. military veteran aged between 18-65.

Negative pregnancy test on MRI scan days

Score greater than or equal to 10 on the Suicide Rumination Scale

Exclusion Criteria

History of moderate or severe traumatic brain injury

Current substance use disorder

Pregnant or trying to become pregnant

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive real-time fMRI neurofeedback to reduce suicide-specific rumination

2 weeks

2 sessions (in-person)

Transfer

Participants utilize mental strategies without receiving neurofeedback signals

1 month

Follow-up

Participants are monitored for changes in rumination, disability, functional impairment, and quality of life

1 month

Post-treatment assessments

What Are the Treatments Tested in This Trial?

Interventions

• Real Time fMRI Neurofeedback

Trial Overview The intervention being tested is Real Time fMRI Neurofeedback, which provides participants with live feedback on brain activation associated with repetitive focus on suicidal thoughts, in hopes of teaching them how to alter this activity.

How Is the Trial Designed?

Group I: Real-time fMRI Neurofeedback Experimental Treatment 1 Intervention

This is a pilot study to collect feasibility and acceptability data regarding the utility of real-time functional magnetic resonance imaging feedback for veterans experiencing suicide-specific rumination. All study participants will receive the intervention.

Real Time fMRI Neurofeedback is already approved in United States, European Union for the following indications:

Approved in United States as Real-time fMRI Neurofeedback for:

• Research use for conditions such as depression, anxiety, and suicidal thoughts

Approved in European Union as rt-fMRI NF for:

• Research use for conditions such as depression, anxiety, and neurological disorders

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

In a pilot study involving 16 patients with major depressive disorder (MDD) and 19 healthy controls, real-time functional MRI neurofeedback (rtfMRI NF) training showed changes in brain connectivity, particularly between the insula and dorsolateral prefrontal cortex, indicating potential neurobiological impacts of the intervention.

Despite these neurobiological changes, the rtfMRI NF training did not lead to significant improvements in depressive symptoms as measured by psychometric scores, suggesting that while the technique may influence brain activity, it may not yet translate to clinical efficacy in symptom reduction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Individual- and Connectivity-Based Real-Time fMRI Neurofeedback to Modulate Emotion-Related Brain Responses in Patients with Depression: A Pilot Study. Maywald, M., Paolini, M., Rauchmann, BS., et al.[2022]

This study investigates the use of real-time functional magnetic resonance imaging (rtfMRI) neurofeedback training (NFT) in alcohol-dependent patients to help them manage cravings and prevent relapse, with participants receiving six NFT sessions over four months.

The primary goal is to determine if NFT can effectively teach participants to regulate their brain responses to alcohol-related stimuli, potentially leading to reduced alcohol consumption, as measured by various metrics such as days abstinent and drinking frequency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurofeedback training for alcohol dependence versus treatment as usual: study protocol for a randomized controlled trial. Cox, WM., Subramanian, L., Linden, DE., et al.[2022]

Real-time functional magnetic resonance imaging-based neurofeedback (rt-fMRI NF) is a promising technique for treating depression by training individuals to self-regulate brain areas like the amygdala, which is often overactive in response to negative stimuli.

Initial randomized controlled trials show promising results for rt-fMRI NF in improving emotional processing, but further research is needed to determine the best methods, target regions, and training durations for lasting clinical benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Application of Real-Time fMRI-Based Neurofeedback for Depression. Mathiak, K., Keller, M.[2021]

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]

Real-time functional magnetic resonance imaging neurofeedback (rtfMRI-NF) shows a medium-sized effect on neural activity during training and a large effect on neural activity after training, indicating its potential to influence brain function in psychiatric disorders.

Behavioral outcomes from rtfMRI-NF, such as symptom reduction, show a small effect size, suggesting that while rtfMRI-NF can impact brain activity, its effects on behavior may be less pronounced and require further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy of real-time functional magnetic resonance imaging neurofeedback for psychiatric illness: A meta-analysis of brain and behavioral outcomes. Dudek, E., Dodell-Feder, D.[2022]

A systematic review of 11 reports from four randomized control trials found that real-time functional magnetic resonance imaging neurofeedback (rt-fMRI-nf) training showed a tendency to improve clinical depression scores, but the overall effect was not statistically significant (SMD -0.32).

While changes in brain activation patterns were observed after rt-fMRI-nf training, the evidence regarding its effectiveness for treating clinical depression remains of low certainty, indicating that more high-quality studies are needed to assess its impact on quality of life and other outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-Time fMRI Neurofeedback Training as a Neurorehabilitation Approach on Depressive Disorders: A Systematic Review of Randomized Control Trials. González Méndez, PP., Rodino Climent, J., Stanley, JA., et al.[2022]

In a study involving 10 individuals with a history of major depressive disorder (MDD) and 12 healthy controls, real-time fMRI neurofeedback (rtfMRI-nf) targeting the connectivity between the amygdala and prefrontal regions showed potential for enhancing emotional regulation, particularly in healthy individuals who exhibited increased frontal cortex activation during training.

Participants with a history of MDD demonstrated a trend towards decreased functional connectivity over the training runs, and while the overall group experienced a reduction in negative emotions, the MDD group specifically showed a significant decrease in positive emotions after the neurofeedback sessions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Connectivity based Real-Time fMRI Neurofeedback Training in Youth with a History of Major Depressive Disorder. He, X., Moreno, DR., Hou, Z., et al.[2023]

Neurofeedback (NFB) enables individuals to consciously control their brain activity by using real-time feedback from their neural activity, which has been traditionally done with EEG and is now enhanced by fMRI for better spatial resolution.

fMRI-NFB is feasible and can serve as a supplementary therapy tool, potentially improving treatment outcomes by allowing for more precise targeting of brain regions involved in various conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional magnetic resonance imaging (FMRI) neurofeedback: implementations and applications. Dewiputri, WI., Auer, T.[2022]

Real-time fMRI (rtfMRI) allows for immediate analysis of brain activity, enabling applications like neurofeedback, which can help individuals learn to self-regulate their brain responses, particularly in areas related to pain and emotional processing.

Initial studies using rtfMRI neurofeedback have shown promising results in improving conditions such as pain, tinnitus, and depression, suggesting its potential as a therapeutic tool that warrants further clinical research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-time fMRI and its application to neurofeedback. Weiskopf, N.[2021]

Citations

1. reporter.nih.gov reporter.nih.gov/search/rVDRLxMdmkuGXMbLdSgd-g/project-details/11132585

Reducing Suicide-Specific Rumination in Veterans using ... In the proposed study we will determine the acceptability and feasibility of using real-time functional magnetic resonance imaging neurofeedback to reduce ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0005796724000494

Ventromedial prefrontal cortex activation and ... The efficacy of real-time functional magnetic resonance imaging neurofeedback for psychiatric illness: A meta-analysis of brain and behavioral outcomes ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7856210/

A meta-analysis of brain and behavioral outcomes - PMC We present the first meta-analysis of rtfMRI-NF for psychiatric disorders, evaluating its impact on brain and behavioral outcomes.

4. frontiersin.org frontiersin.org/journals/human-neuroscience/articles/10.3389/fnhum.2022.910951/full

Real-Time Functional Magnetic Resonance Imaging ... Real-time fMRI (rt-fMRI) neurofeedback can be used to non-invasively modulate brain activity and has shown initial effectiveness in symptom reduction for ...

5. bmcpsychiatry.biomedcentral.com bmcpsychiatry.biomedcentral.com/articles/10.1186/s12888-023-05223-8

Mindfulness-based real-time fMRI neurofeedback Preliminary results from a recent proof-of-concept trial suggest reduced rumination among depressed adults following real-time neurofeedback ...

6. psychiatryonline.org psychiatryonline.org/doi/10.1176/appi.ajp.2017.16060637

Randomized Clinical Trial of Real-Time fMRI Amygdala ... The authors examined the therapeutic efficacy of real-time functional MRI neurofeedback (rtfMRI-nf) training aimed at increasing the amygdala's ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S221315821830192X

Single session real-time fMRI neurofeedback has a lasting ... Rt-fMRI neurofeedback created a salient and durable learning experience for patients, extending beyond the scan session to guide and motivate CBT skill use ...