Recruiting

Observational Study

Sponsor:

University of Florida

Code:

NCT05457725

Conditions

Aging

Cognitive Change

Neurocognitive Disorders, Mild

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Contingent rtfMRI neurofeedback training

Non-contingent/sham rtfMRI neurofeedback training

Study Details

Brief 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. 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.

Conditions

Aging

Cognitive Change

Neurocognitive Disorders, Mild

Study ID

NCT05457725

Start date

Oct 8, 2024

Status verified date

Apr, 2026

Completion date

Apr 30, 2027

Anticipated

Primary completion date

Apr 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not 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

Study Design

Enrollment

68 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: 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.

sham comparator: 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.

Interventions

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.

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.

Primary outcome measure

  • Neurofeedback Training Success [ Time Frame: at baseline and after training completion about 1 week later ]
  • Behavioral Benefits [ Time Frame: at baseline and after training completion about 1 week later ]

Central Contacts and Locations

Central contacts

Dana Arnold, M.S.

401-617-6061arnold.d@ufl.edu

Ryan Faulkner

727-771-5247faulkerryan@ufl.edu

Locations

University of Florida

Recruiting

Gainesville, Florida, United States, 32611

Contacts

Dana Arnold

352-273-2141

Principal Investigator:

Natalie Ebner, PhD

More Information

Sponsor

University of Florida

Last update posted

Apr 6, 2026

Last verified

Apr, 2026

Keywords

  • Decision Making
  • Trust
  • Learning
  • Socioemotional
  • Vulnerability to Exploitation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Florida on 2026-04-06.