AgingDecidingBrainNCT05457725
Modulating Neurocognitive Processes of Learning to Trust and Distrust in Aging
A study testing Contingent rtfMRI neurofeedback training in people with Aging and Cognitive Change, run by University of Florida at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Aging, Cognitive Change, Neurocognitive Disorders, Mild
- What is being tested?
- Contingent rtfMRI neurofeedback training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Oct 2024to 30 Apr 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to provide verbal and written informed consent
- Fluent English speaker
- At least 8th grade education
- On stable medication regimen
Who cannot join
- Pregnancy
- Magnetic resonance imaging contraindications (e.g., certain metallic objects in body, claustrophobia)
- Current major depression defined as scores >14 on the Beck Depression Inventory-II
- Impaired scores on the Telephone Interview for Cognitive Status (TICS; cut-off of >30)
- Current use of medications with significant anticholinergic properties due to potential influence on memory ("memory enhancing"; e.g., Aricept or Namenda)
- Current use of anticonvulsant, neuroleptic, sedatives, or other medications known to affect cognition
Show all 12Show fewer
- Uncorrected visual and hearing impairments
- Neurologic conditions affecting the brain (e.g., severe stroke, epilepsy, traumatic brain injury with >30-minute loss of consciousness)
- Impaired scores on a cognitive screening measure, the Montreal Cognitive Assessment (MoCA); for older adults the cutoff will be age and education corrected
- Unstable medical illness (e.g., metastatic cancer)
- Significant cardiovascular conditions (e.g., major heart attack)
- Will not exclude participants who are taking anti-depressant medications. Use of antidepressants (particularly SSRI's) and anxiolytic medications will be recorded and included in post-hoc analyses
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sarah G. Verdecia-Zabala contact
United States1 site, 1 recruiting
- Recruiting
University of Florida
Gainesville, Florida, 32611
Dana Arnold, 352-273-2141
Natalie Ebner, PhD
About this study
Official title: Characterizing and Modulating Neurocognitive Processes of Learning to Trust and Distrust in Aging II
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.
Read the detailed description
This study will apply rtfMRI neurofeedback training as an intervention method, to demonstrate that older adults can be trained in volitional brain activity up-regulation, reducing their trust-learning deficits. The study will comprises several MRI sessions including pre-training, training, and post-training scans.
- Conditions
- Aging, Cognitive Change, Neurocognitive Disorders, Mild
- Being tested
- Contingent rtfMRI neurofeedback training, Non-contingent/sham rtfMRI neurofeedback training
- Keywords
- Decision Making, Trust, Learning, Socioemotional, Vulnerability to Exploitation
- Medical subject headings
- Neurocognitive Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contingent rtfMRI neurofeedback trainingBehavioural
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.
Non-contingent/sham rtfMRI neurofeedback trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Contingent rtfMRI neurofeedback training | Experimental | 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. Receives: Behavioral: Contingent rtfMRI neurofeedback training |
| Non-contingent/sham rtfMRI neurofeedback training | Sham comparator | 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. Receives: Behavioral: Non-contingent/sham rtfMRI neurofeedback training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurofeedback Training Success
Increase in BOLD signal in ROI during up-regulation trials administration of computerized learning tasks, with contrasting groups and conditions
Measured: at baseline and after training completion about 1 week later
Behavioral Benefits
Increase in trust-related learning reflected in greater accuracy (e.g., in percent) on trust learning task
Measured: at baseline and after training completion about 1 week later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2022
- Study start8 Oct 2024
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Between subject design (experimental vs. control)
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Natalie C. Ebner, PhD., Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05457725
- Sponsor's protocol ID
- IRB202400337
- Other IDs
- R01AG072658
- Acronym
- DecidingBrain
- Status last verified
- Apr 2026
- First submitted
- 11 Jul 2022
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: De-identified data may be shared with other researchers for secondary data analysis.