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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
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Neurocognitive Disorders focused on measuring Decision Making, Trust

Eligibility Criteria

60 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    July 11, 2022
    Last Updated
    September 15, 2023
    Sponsor
    University of Florida
    Collaborators
    National Institute on Aging (NIA)
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    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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