Neurofeedback for Suicide Prevention

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

Trial Summary

What is the purpose of this trial?

This trial uses real-time brain imaging to help Veterans at high risk of suicide learn to manage their suicidal thoughts. By showing them their brain activity, they can practice ways to change it and reduce harmful thinking patterns. The goal is to improve their quality of life and reduce the risk of suicide.

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 data supports the effectiveness of the treatment Real Time fMRI Neurofeedback for suicide prevention?

Real-time fMRI neurofeedback has shown promise in helping people with depression by allowing them to train and regulate specific brain areas related to emotions. Studies suggest it can change brain activity patterns and may help improve depressive symptoms, which could indirectly support its potential for suicide prevention. ^{1 2 3 4 5}

Is real-time fMRI neurofeedback safe for humans?

Current studies on real-time fMRI neurofeedback, mainly for depression, suggest it is generally safe, but more research is needed to fully understand its safety, including potential side effects and long-term impacts. ^{2 3 4 5 6}

How is the treatment Real Time fMRI Neurofeedback different from other treatments for suicide prevention?

Real Time fMRI Neurofeedback is unique because it uses real-time brain imaging to help patients learn to control their brain activity, which is different from traditional therapies that do not provide immediate feedback on brain function. This approach allows for precise targeting of brain areas involved in emotional regulation, potentially offering a novel way to address underlying issues related to suicidal thoughts. ^{3 4 7 8 9}

Research Team

Philip R Szeszko, PhD

Principal Investigator

James J. Peters Veterans Affairs Medical Center

Eligibility Criteria

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

Negative pregnancy test on MRI scan days

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

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

Exclusion Criteria

I don't have any major health or brain disorders that could affect my treatment.

Current substance use disorder

History of moderate or severe traumatic brain injury

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Neurofeedback and networks of depression. [2021]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Real-Time fMRI Neurofeedback Training as a Neurorehabilitation Approach on Depressive Disorders: A Systematic Review of Randomized Control Trials. [2022]

3. Switzerland 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. [2022]

4. United States 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. [2022]

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

Clinical Application of Real-Time fMRI-Based Neurofeedback for Depression. [2021]

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

Connectivity based Real-Time fMRI Neurofeedback Training in Youth with a History of Major Depressive Disorder. [2023]

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

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

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

Neurofeedback training for alcohol dependence versus treatment as usual: study protocol for a randomized controlled trial. [2022]

9. Malaysia pubmed.ncbi.nlm.nih.gov

Functional magnetic resonance imaging (FMRI) neurofeedback: implementations and applications. [2022]