Modulating Neurocognitive Processes of Learning to Trust and Distrust in Aging

Aging Clinical Trial

— DecidingBrain  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05457725
• Other study ID #: IRB202400337
• Secondary ID: R01AG072658
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 1, 2024
• Est. completion date: March 31, 2027

Study information

• Verified date: June 2024
• Source: University of Florida
• Contact: Dana Arnold, M.S.
• Phone: 401-617-6061
• Email: arnold.d[@]ufl.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 compromise of several MRI sessions including pre-training, training, and post-training scans.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 68
• Est. completion date: March 31, 2027
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Aging
• Cognitive Change
• Neurocognitive Disorders

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	National Institute on Aging (NIA)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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