NCT05574634

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 disconnectivity 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
14mo left

Started Apr 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress73%
Apr 2023Jun 2027

First Submitted

Initial submission to the registry

September 13, 2022

Completed
27 days until next milestone

First Posted

Study publicly available on registry

October 10, 2022

Completed
6 months until next milestone

Study Start

First participant enrolled

April 11, 2023

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2027

Last Updated

August 19, 2025

Status Verified

August 1, 2025

Enrollment Period

4.2 years

First QC Date

September 13, 2022

Last Update Submit

August 13, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

    Scan before and after attentional practice (2 weeks between scans)

  • Change in fMRI LC-SN connectivity after two weeks

    An fMRI measure of LC-SN connectivity

    Scan before and after attentional practice (2 weeks between scans)

Study Arms (2)

Older adult participants

EXPERIMENTAL

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

Behavioral: Tablet based adaptive multimodal attention practice programBehavioral: Tablet based adaptive criterion task practice program

Younger adult participants

NO INTERVENTION

Younger adult participants in the study will complete one fMRI scan session featuring an attention task

Interventions

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.

Older adult participants

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.

Older adult participants

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy adult participants
  • No younger than 18 and no older than 75 yrs of age
  • Ability to provide written informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virginia Polytechnic Institute and State University

Blacksburg, Virginia, 24061, United States

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Tae-Ho Lee, PhD

    Virginia Polytechnic Institute and State University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tae-Ho Lee, PhD

CONTACT

Benjamin Katz, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
The participant will not be aware that there are two alternate versions of the attention practice program.
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2022

First Posted

October 10, 2022

Study Start

April 11, 2023

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

June 30, 2027

Last Updated

August 19, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations