Modulating Neurocognitive Processes of Learning to Trust and Distrust in Aging

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-08

Study Completion Date

2027-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Toward a Generalizable Closed-loop Neurofeedback-based BCI for Attention Training

NCT05908253

Neurofeedback

COMPLETED NA

UCF Deciding Brains

NCT06176092

Trust

RECRUITING

Investigating Electroencephalographic Predictors of Default Mode Network Anticorrelation in Healthy Adults

NCT05592600

Healthy

COMPLETED NA

Dynamic Neural Systems Underlying Social-emotional Functions in Older Adults

NCT05645835

Loneliness Older Adults fMRI +4 more

ACTIVE_NOT_RECRUITING NA

Neurofeedback as a Treatment Tool for Depression

NCT01544205

Unipolar Depression

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Aging Cognitive Change Neurocognitive Disorders, Mild

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Between subject design (experimental vs. control)

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Participant and outcome assessor are not aware of the experimental vs. control

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Contingent rtfMRI neurofeedback training

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 Type EXPERIMENTAL

Contingent rtfMRI neurofeedback training

Intervention Type BEHAVIORAL

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 training

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.

Group Type SHAM_COMPARATOR

Non-contingent/sham rtfMRI neurofeedback training

Intervention Type BEHAVIORAL

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Contingent rtfMRI neurofeedback training

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.

Intervention Type BEHAVIORAL

Non-contingent/sham rtfMRI neurofeedback training

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Able to provide verbal and written informed consent
* Fluent English speaker
* At least 8th grade education
* On stable medication regimen

Exclusion Criteria

* 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
* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No