Modulating Neurocognitive Processes of Learning to Trust and Distrust in Aging

NCT05457725 | Recruiting

• 2 other identifiers: IRB202400337R01AG072658
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Neurofeedback Training Success

  Increase in BOLD signal in ROI during up-regulation trials administration of computerized learning tasks, with contrasting groups and conditions

  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

  at baseline and after training completion about 1 week later

Study Arms (2)

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.

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.

Behavioral: Non-contingent/sham rtfMRI neurofeedback training

Interventions

Contingent rtfMRI neurofeedback training 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.

Contingent rtfMRI neurofeedback training

Non-contingent/sham rtfMRI neurofeedback training 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.

Non-contingent/sham rtfMRI neurofeedback training

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of Florida

Gainesville, Florida, 32611, United States

RECRUITING

MeSH Terms

Conditions

Neurocognitive Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Natalie C. Ebner, PhD.

  University of Florida

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dana Arnold, M.S.

CONTACT

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

Ryan Faulkner

CONTACT

727-771-5247; faulkerryan@ufl.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participant and outcome assessor are not aware of the experimental vs. control
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Between subject design (experimental vs. control)

Study Record Dates

• First Submitted: July 11, 2022
• First Posted: July 14, 2022
• Study Start: October 8, 2024
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: March 4, 2025

Record last verified: 2025-03

Locations

US (1)