Modulating Neurocognitive Processes of Learning to Trust and Distrust in Aging
Primary Purpose
Neurocognitive Disorders, Aging, Cognitive Change
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
rtfMRI-guided Neurofeedback Training
Sham Control
Sponsored by
About this trial
This is an interventional basic science trial for Neurocognitive Disorders focused on measuring Decision Making, Trust
Eligibility Criteria
Inclusion Criteria:
- Able to provide verbal and written informed consent
- Fluent English speaker
- At least 8th grade education
- Age between 60-85 years
- 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., 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
rtfMRI-guided Neurofeedback Training
Sham control
Arm Description
Real-time functional magnetic resonance imaging guided neurofeedback
non-contingent-sham neurofeedback
Outcomes
Primary Outcome Measures
Functional Magnetic Resonance Imaging
Measures of neural activity are obtained using functional magnetic resonance imaging during administration of computerized learning tasks, with contrasting groups and conditions
Secondary Outcome Measures
Full Information
NCT ID
NCT05457725
First Posted
July 11, 2022
Last Updated
September 15, 2023
Sponsor
University of Florida
Collaborators
National Institute on Aging (NIA)
1. Study Identification
Unique Protocol Identification Number
NCT05457725
Brief Title
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
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 2024 (Anticipated)
Primary Completion Date
February 27, 2027 (Anticipated)
Study Completion Date
March 31, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
Collaborators
National Institute on Aging (NIA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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. The proposed work is conceptually embedded in the Changes in Integration for Social Decisions in Aging (CISDA) framework. This framework describes how the integration of decision-relevant information is impacted by trajectories of change in theory of mind, memory systems, and social-emotional processing with age. Two innovative trust-learning paradigms - the Social Iowa Gambling Task (sIGT) and the FLorida-Arizona Gambling Task (FLAG) - will be leveraged to test CISDA predictions. Aim: Probe the malleability of the underlying neurocircuitry of trust-learning deficits in aging. This study will utilize real-time fMRI neurofeedback to train healthy older adults in anterior cingulate cortex 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 healthy older adults can be trained in volitional up-regulation of ACC activity, reducing their trust-learning deficits. The study will compromise 4 MRI sessions: 1 pre-training scan, 2 training scans, and 1 post-training scan. Number and duration of scans are based on our feasibility data showing that older adults were able to up-regulate ROI activity after two 1-h training sessions. After the post-training scan, the effects of neurofeedback training on far transfer to phishing susceptibility and exploitation risks will be assessed using PEST and our survey measures.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neurocognitive Disorders, Aging, Cognitive Change
Keywords
Decision Making, Trust
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
68 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
rtfMRI-guided Neurofeedback Training
Arm Type
Experimental
Arm Description
Real-time functional magnetic resonance imaging guided neurofeedback
Arm Title
Sham control
Arm Type
Sham Comparator
Arm Description
non-contingent-sham neurofeedback
Intervention Type
Behavioral
Intervention Name(s)
rtfMRI-guided Neurofeedback Training
Intervention Description
Real-time functional magnetic resonance imaging guided neurofeedback is a non-invasive procedure that provides a visual of participants' current blood oxygen-level-dependent (BOLD) signal in response to a specific task or stimulus in a targeted brain region relative to a control region. Participants use real-time neurofeedback to modulate targeted BOLD signals in their own brain. This technique is used in Study 3. The study does not assess change in a health condition. It evaluates the effect of real-time functional magnetic resonance imaging guided neurofeedback (vs. sham neurofeedback) on trust-related learning in older adults.
Intervention Type
Behavioral
Intervention Name(s)
Sham Control
Intervention Description
Sham control is the neurofeedback that was previously recorded from a patient, a non-invasive procedure used as a placebo
Primary Outcome Measure Information:
Title
Functional Magnetic Resonance Imaging
Description
Measures of neural activity are obtained using functional magnetic resonance imaging during administration of computerized learning tasks, with contrasting groups and conditions
Time Frame
90 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Able to provide verbal and written informed consent
Fluent English speaker
At least 8th grade education
Age between 60-85 years
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., 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dalia El-Shafie
Phone
(941)960-0427
Email
elshafie.d@ufl.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Dana Arnold
Phone
401-617-6061
Email
arnold.d@ufl.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Natalie Ebner, PhD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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Modulating Neurocognitive Processes of Learning to Trust and Distrust in Aging
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