Clinical trial NCT05457725: Modulating Neurocognitive Processes of Learning to Trust and Distrust in Aging
Official title: Characterizing and Modulating Neurocognitive Processes of Learning to Trust and Distrust in Aging II
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Aging
Cognitive Change
Neurocognitive Disorders, Mild
Keywords: Decision Making
Trust
Learning
Socioemotional
Vulnerability to Exploitation
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2022-07-14
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Between subject design (experimental vs. control)
Primary purpose: BASIC_SCIENCE

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.

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.

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

Primary outcomes:
measure: Neurofeedback Training Success
timeFrame: at baseline and after training completion about 1 week later
measure: Behavioral Benefits
timeFrame: at baseline and after training completion about 1 week later
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Natalie C. Ebner, PhD.
role: PRINCIPAL_INVESTIGATOR
References: