Neurofeedback Training for Aging

(DecidingBrain Trial)

Overseen By Ryan Faulkner

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Florida

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

Disqualifiers: Pregnancy, Major depression, Neurologic conditions, others

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

Compensation: Varies

Number of Visits: 2

68 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how brain training can assist older adults with trust-related decision-making. It focuses on using real-time brain imaging (fMRI) to guide neurofeedback training, enhancing participants' ability to learn trust. This method is known as rtfMRI-guided Neurofeedback Training. Participants are divided into two groups: one receives real feedback, and the other receives simulated feedback (Sham Control). Ideal candidates are older adults who speak English fluently, have at least an 8th-grade education, and maintain a stable medication regimen. As an unphased trial, this study allows participants to contribute to groundbreaking research in cognitive health.

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 prior data suggests that this neurofeedback training is safe for aging individuals?

Studies have shown that real-time fMRI neurofeedback training is generally safe for people. Both young and older adults have used this training without major problems. In past studies, participants learned to control certain brain areas using this feedback. Extensive reports of negative side effects or serious safety concerns are absent, suggesting that the treatment is well-tolerated. For those considering joining a trial using this method, existing research supports its safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about rtfMRI-guided neurofeedback training for aging because it offers a novel approach that directly targets brain activity in real-time. Unlike traditional methods that might involve medication or cognitive exercises, this technique provides immediate visual feedback on brain activity. The contingent neurofeedback arm allows participants to see and potentially influence their own brain activity, which could lead to enhanced cognitive function. This personalized approach is different from current treatments and holds promise for improving brain health in aging populations.

What evidence suggests that rtfMRI-guided Neurofeedback Training is effective for trust-related decision making in aging?

Research shows that real-time brain scans used for feedback can enhance thinking skills as people age. In this trial, participants will receive either contingent rtfMRI neurofeedback training or non-contingent/sham rtfMRI neurofeedback training. One study found that this method improved focus in both young and older individuals. Another study discovered that older adults and those with early signs of Alzheimer's disease had better memory after this training. This technique has also improved behavior in individuals with conditions like schizophrenia and nicotine addiction. These findings suggest that this brain training might help older adults make better decisions by enhancing brain function. ^{2 3 4 6 7}

Who Is on the Research Team?

Natalie C. Ebner, PhD.

Principal Investigator

University of Florida

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• rtfMRI-guided Neurofeedback Training
• Sham Control

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 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]

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]

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]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11430676/

Real-Time fMRI Neurofeedback Training of Selective Attention ...

Results provide crucial proof of concept of rtfMRI neurofeedback training in cognitive aging, supporting both neurofeedback training success ...

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39335425/

Real-Time fMRI Neurofeedback Training of Selective Attention ...

This study used rtfMRI neurofeedback to train 19 young and 27 older adults in volitional up- or down-regulation of bilateral dACC during a selective attention ...

3.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0149763420306953

The efficacy of real-time functional magnetic resonance ...

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/neurology/articles/10.3389/fneur.2017.00384/full

Cognitive Improvement and Brain Changes after Real ...

Results: Healthy elderly and patients with prodromal AD showed improved visuospatial memory performance after neurofeedback training. Healthy subjects also ...

5.

withpower.com

withpower.com/trial/neurofeedback-training-for-aging-4c11e

Neurofeedback Training for Aging (DecidingBrain Trial)

Research shows that real-time fMRI neurofeedback can lead to behavioral improvements in conditions like schizophrenia and nicotine addiction, and there is ...

6.

mdpi.com

mdpi.com/2076-3425/14/9/931

Real-Time fMRI Neurofeedback Training of Selective ...

This study used rtfMRI neurofeedback to train 19 young and 27 older adults in volitional up- or down-regulation of bilateral dACC during a selective attention ...

7.

frontiersin.org

frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2021.715898/full

fMRI Neurofeedback-Enhanced Cognitive Reappraisal ...

Rt-fMRI neurofeedback-guided cognitive reappraisal training modulates amygdala responsivity in posttraumatic stress disorder. NeuroImage ...