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Recruiting NCT05457725

Modulating Neurocognitive Processes of Learning to Trust and Distrust in Aging

No phase Interventional Aging Cognitive Change Neurocognitive Disorders, Mild

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Contingent rtfMRI neurofeedback training, Non-contingent/sham rtfMRI neurofeedback training.
Who it may be relevant to
Registry conditions: Aging, Cognitive Change, Neurocognitive Disorders, Mild. Basic parameters: 18 years — 100 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Characterizing and Modulating Neurocognitive Processes of Learning to Trust and Distrust in Aging II

Overview

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.

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.

Interventions

  • Behavioral 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.
  • 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.

Primary outcome measures

  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Basic science

Study locations

United States · 1 center
  • University of Florida — Gainesville

Identifiers

NCT: NCT05457725 · IRB202400337 · R01AG072658

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗