Neurofeedback Training for Aging

(DecidingBrain Trial)

Overseen By Ryan Faulkner

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Florida

Must not be taking: Anticholinergics, Anticonvulsants, Neuroleptics, Sedatives

Disqualifiers: Pregnancy, Major depression, Neurologic conditions, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

Much of human interaction is based on trust. Aging has been associated with deficits in trust-related decision making, likely further exacerbated in age-associated neurodegenerative disease (Alzheimer's disease/AD), possibly underlying the dramatically growing public health problem of elder fraud. Optimal trust-related decision making and avoiding exploitation require the ability to learn about the trustworthiness of social partners across multiple interactions, but the role that learning plays in determining age deficits in trust decisions is currently unknown. Aim: Probe the malleability of the underlying neurocircuitry of trust-learning deficits in aging. This study will utilize real-time fMRI neurofeedback to train older adults in brain activity up-regulation toward enhanced trust-related learning in aging and confirm critical mechanisms of experience-dependent social decisions in aging. Grant R01AG072658 Aim 3: Test the malleability of trust-learning neurocircuitry toward optimized trust-related decision making in aging.

Will I have to stop taking my current medications?

The trial requires that you are on a stable medication regimen, so you won't need to stop your current medications unless they are anticholinergics, anticonvulsants, neuroleptics, sedatives, or other drugs known to affect cognition.

What data supports the effectiveness of the treatment rtfMRI-guided Neurofeedback Training for aging?

Research shows that real-time fMRI neurofeedback can lead to behavioral improvements in conditions like schizophrenia and nicotine addiction, and there is emerging evidence that it may help older adults control brain activity to potentially alleviate cognitive decline. ^{1 2 3 4 5}

Is neurofeedback training using real-time fMRI safe for humans?

Real-time fMRI neurofeedback has been used in various studies and is generally considered safe for humans, with no extensive reports of adverse events. It has been applied in research for conditions like schizophrenia and nicotine addiction, showing behavioral benefits without significant safety concerns. ^{1 6 7 8 9}

How is rtfMRI-guided Neurofeedback Training different from other treatments for cognitive decline in aging?

rtfMRI-guided Neurofeedback Training is unique because it uses real-time brain imaging to help individuals learn to control their brain activity, potentially improving cognitive functions like attention and memory. Unlike traditional cognitive training, this method provides immediate feedback on brain activity, allowing for more targeted and personalized interventions. ^{1 2 3 5 9}

Research Team

Natalie C. Ebner, PhD.

Principal Investigator

University of Florida

Eligibility Criteria

This trial is for individuals aged 60-85 who can consent, speak English fluently, have at least an 8th-grade education level, and are on a stable medication regimen. It's focused on those experiencing mild cognitive impairments or changes in trust-related decision making as they age.

Inclusion Criteria

Able to provide verbal and written informed consent

Fluent English speaker

At least 8th grade education

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-training

Participants undergo pre-training MRI scans to establish baseline brain activity

1 week

1 visit (in-person)

Training

Participants receive rtfMRI neurofeedback training to enhance trust-related learning

1 week

Multiple sessions (in-person)

Post-training

Participants undergo post-training MRI scans to assess changes in brain activity

1 week

1 visit (in-person)

Follow-up

Participants are monitored for changes in trust-related learning and decision making

4 weeks

Treatment Details

Interventions

• rtfMRI-guided Neurofeedback Training (Behavioral Intervention)
• Sham Control (Behavioral Intervention)

Trial Overview The study tests whether real-time fMRI neurofeedback training can help older adults improve their ability to learn about trustworthiness in social interactions. Participants will receive either direct feedback (contingent) or placebo-like feedback (non-contingent/sham) during the sessions.

Participant Groups

Group I: Contingent rtfMRI neurofeedback training Experimental Treatment 1 Intervention

Contingent rtfMRI neurofeedback training will follow an alternating up-regulation/rest block design with screen-color cues. Visual feedback about real-time brain activity in the ROI will be provided (e.g., via a thermometer bar). During resting blocks, the thermometer bar remains static.

Group II: Non-contingent/sham rtfMRI neurofeedback training Placebo Group 1 Intervention

Non-contingent/sham rtfMRI neurofeedback training will follow an alternating up-regulation/rest block design with screen-color cues. Visual feedback about non-contingent/sham brain activity in the ROI will be provided (e.g., via a thermometer bar). During resting blocks, the thermometer bar remains static.

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Findings from Research

Cognitive decline is common in aging, but maintaining cognitive function is essential for independence, making it important to explore interventions that can counteract this decline.

Preliminary results from a feasibility study suggest that real-time functional magnetic resonance imaging (rtfMRI) neurofeedback may help older adults learn to control their brain activity, potentially offering a novel approach to mitigate cognitive decline.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-Time fMRI in Neuroscience Research and Its Use in Studying the Aging Brain. Rana, M., Varan, AQ., Davoudi, A., et al.[2020]

The first international conference on real-time functional magnetic resonance imaging (rtfMRI) neurofeedback highlighted significant advancements in the field, focusing on its potential applications in both scientific research and clinical settings.

Discussions at the conference addressed key debates and open questions regarding study design and the mechanisms of learning involved in rtfMRI, indicating a need for further exploration to optimize its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-time fMRI neurofeedback: progress and challenges. Sulzer, J., Haller, S., Scharnowski, F., et al.[2023]

Neurofeedback (NF) has been shown to enhance cognitive functions like attention and working memory, particularly in children with ADHD, and there is growing evidence that it can also benefit older adults by helping their brain function more like that of younger individuals.

Recent advancements in technology, such as wireless brain activity recording and machine learning, are paving the way for more effective NF training, offering hope for improving cognitive performance and combating age-related cognitive decline in older populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tuning Up the Old Brain with New Tricks: Attention Training via Neurofeedback. Jiang, Y., Abiri, R., Zhao, X.[2020]

Real-time functional MRI neurofeedback (rtfMRI-nf) enables individuals to self-regulate brain activity in specific areas, which can influence behaviors linked to those regions, showing potential for treating mental disorders.

While rtfMRI-nf shows promise as a therapeutic tool for mental health, further research is needed to understand its effectiveness and the underlying neural mechanisms involved.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-time functional MRI neurofeedback: a tool for psychiatry. Kim, S., Birbaumer, N.[2014]

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 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]

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 114 chronic pain patients and 641 functional imaging scans, there were no significant increases in reported adverse events during fMRI or real-time fMRI (rtfMRI) training sessions compared to baseline sessions, indicating a strong safety profile for these procedures.

Over 90% of rtfMRI training sessions reported no adverse events, and when events did occur, they were mostly mild or moderate, suggesting that rtfMRI training is a safe approach for altering brain activation without increasing risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quantification of adverse events associated with functional MRI scanning and with real-time fMRI-based training. Hawkinson, JE., Ross, AJ., Parthasarathy, S., et al.[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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Real-Time fMRI in Neuroscience Research and Its Use in Studying the Aging Brain. [2020]

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

Real-time fMRI neurofeedback: progress and challenges. [2023]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Tuning Up the Old Brain with New Tricks: Attention Training via Neurofeedback. [2020]

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

Real-time functional MRI neurofeedback: a tool for psychiatry. [2014]

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

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

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

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

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

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

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

Quantification of adverse events associated with functional MRI scanning and with real-time fMRI-based training. [2021]

9. 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]