- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05457725
Modulating Neurocognitive Processes of Learning to Trust and Distrust in Aging (DecidingBrain)
Characterizing and Modulating Neurocognitive Processes of Learning to Trust and Distrust in Aging II
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.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Dana Arnold, M.S.
- Phone Number: 401-617-6061
- Email: arnold.d@ufl.edu
Study Contact Backup
- Name: Ryan Faulkner
- Phone Number: 727-771-5247
- Email: faulkerryan@ufl.edu
Study Locations
-
-
Florida
-
Gainesville, Florida, United States, 32611
- Recruiting
- University of Florida
-
Principal Investigator:
- Natalie Ebner, PhD
-
Contact:
- Dana Arnold
- Phone Number: 352-273-2141
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Neurofeedback Training Success
Time Frame: at baseline and after training completion about 1 week later
|
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
Time Frame: at baseline and after training completion about 1 week later
|
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
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Natalie C. Ebner, PhD., University of Florida
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB202400337
- R01AG072658 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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