The Role of the Locus Coeruleus in Age-related Distractibility
Primary Purpose
Aging, Alzheimer Disease
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tablet based adaptive multimodal attention practice program
Tablet based adaptive criterion task practice program
Sponsored by
About this trial
This is an interventional basic science trial for Aging
Eligibility Criteria
Inclusion:
- Healthy adult participants
- No younger than 18 and no older than 75 yrs of age
- Ability to provide written informed consent
Exclusion:
- History of surgery involving metal implants
- Possible metal fragments in the eyes
- Pacemaker
- A history of claustrophobia
- Braces
- Weighing over 250 pounds
- Pregnant or possibility of being pregnant.
- Severe medical or psychiatric conditions (e.g., blind or deaf, head trauma)
- Learning disabilities or developmental disabilities
Sites / Locations
- Virginia Polytechnic Institute and State UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Older adult participants
Younger adult participants
Arm Description
Older adult participants in the study will complete one of two variants of an attention practice program and that will be preceded by, and followed by, an fMRI scan session featuring an attention task
Younger adult participants in the study will complete one fMRI scan session featuring an attention task
Outcomes
Primary Outcome Measures
Change in accuracy on the place-face selective attention task after two weeks
During this task, participants will be presented to with target place stimuli overlaid on nonexpressive faces) and be asked to identify categories of place images ('building' to 'house') selectively as soon as possible while ignoring overlapped faces. The investigators will also include place only images to measure participants' baseline neural activation when there is no distractor. Each image condition will be presented in a mixed event related design that includes 15 blocks for each condition as a function of image type (overlaid vs. place-only). The block order will be counterbalanced and each block will be separated by a 10-s blank screen.
Change in fMRI LC-SN connectivity after two weeks
An fMRI measure of LC-SN connectivity
Secondary Outcome Measures
Full Information
NCT ID
NCT05574634
First Posted
September 13, 2022
Last Updated
June 2, 2023
Sponsor
Virginia Polytechnic Institute and State University
1. Study Identification
Unique Protocol Identification Number
NCT05574634
Brief Title
The Role of the Locus Coeruleus in Age-related Distractibility
Official Title
Losing Specificity: the Role of the Locus Coeruleus in Age-related Distractibility
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 11, 2023 (Actual)
Primary Completion Date
June 30, 2027 (Anticipated)
Study Completion Date
June 30, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Polytechnic Institute and State University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
A growing body of research has highlighted the importance of frontal regions, at both the functional and structural levels, in age-related declines in attentional and cognitive processing. However, the underlying neurobiological pathophysiological changes in the brain that contribute to these declines are still largely unclear. The objective of this proposal is to investigate neural mechanisms of age-related attentional distractibility, focusing on the neural circuit initiated from the locus coeruleus (LC). In the current proposal, the investigators will test the hypothesis that the neural dysconnectivity of LC with the salience network (SN) drives failures of ignoring distractors in older adults. The investigators will examine how LC-SN connectivity is associated with selective attention performance, and how improved LC-SN connectivity through a cognitive training program may lead to improved attentional performance.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aging, Alzheimer Disease
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
The participant will not be aware that there are two alternate versions of the attention practice program.
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Older adult participants
Arm Type
Experimental
Arm Description
Older adult participants in the study will complete one of two variants of an attention practice program and that will be preceded by, and followed by, an fMRI scan session featuring an attention task
Arm Title
Younger adult participants
Arm Type
No Intervention
Arm Description
Younger adult participants in the study will complete one fMRI scan session featuring an attention task
Intervention Type
Behavioral
Intervention Name(s)
Tablet based adaptive multimodal attention practice program
Intervention Description
An adaptive at-home tablet-based program that includes variants of the Flanker Task, the Stroop Task, and a Visual Tracking Task. Each session of practice will include up to ten minutes with each of these task types, and the tasks will increase in difficulty in a way that further taxes attention (such as through more distractors or more incongruent trials) as participant performance improves.
Intervention Type
Behavioral
Intervention Name(s)
Tablet based adaptive criterion task practice program
Intervention Description
An adaptive, at-home tablet-based variant of the criterion task, that is, the selective attention/distraction task used during the scanning portion of the human participant portions of the study, that takes up to 25 minutes to complete each session.
Primary Outcome Measure Information:
Title
Change in accuracy on the place-face selective attention task after two weeks
Description
During this task, participants will be presented to with target place stimuli overlaid on nonexpressive faces) and be asked to identify categories of place images ('building' to 'house') selectively as soon as possible while ignoring overlapped faces. The investigators will also include place only images to measure participants' baseline neural activation when there is no distractor. Each image condition will be presented in a mixed event related design that includes 15 blocks for each condition as a function of image type (overlaid vs. place-only). The block order will be counterbalanced and each block will be separated by a 10-s blank screen.
Time Frame
Scan before and after attentional practice (2 weeks between scans)
Title
Change in fMRI LC-SN connectivity after two weeks
Description
An fMRI measure of LC-SN connectivity
Time Frame
Scan before and after attentional practice (2 weeks between scans)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion:
Healthy adult participants
No younger than 18 and no older than 75 yrs of age
Ability to provide written informed consent
Exclusion:
History of surgery involving metal implants
Possible metal fragments in the eyes
Pacemaker
A history of claustrophobia
Braces
Weighing over 250 pounds
Pregnant or possibility of being pregnant.
Severe medical or psychiatric conditions (e.g., blind or deaf, head trauma)
Learning disabilities or developmental disabilities
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tae-Ho Lee, PhD
Phone
540-231-6174
Email
taehol@vt.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Benjamin Katz, PhD
Phone
540-231-9816
Email
katzben@vt.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tae-Ho Lee, PhD
Organizational Affiliation
Virginia Polytechnic Institute and State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Polytechnic Institute and State University
City
Blacksburg
State/Province
Virginia
ZIP/Postal Code
24061
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tae-Ho Lee, PhD
Phone
540-231-6174
Email
taehol@vt.edu
First Name & Middle Initial & Last Name & Degree
Benjamin Katz, PhD
Phone
540-231-9816
Email
katzben@vt.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Role of the Locus Coeruleus in Age-related Distractibility
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