NCT03896529

Brief Summary

Two hallmarks of both healthy aging and age-related disease are 1) memory and navigational deficits, particularly in orienting towards goal locations and planning how to navigate to them, and 2) increased susceptibility to stress and altered regulation of the stress response. However, there are marked individual differences in these age-related changes. The investigators' proposal will help characterize factors that contribute to this variability. Participants will be pseudorandomly assigned to stress-manipulated or control groups. The investigators will give both groups a novel immersive navigation task, validated by the PI in healthy young adults. This paradigm gives participants the opportunity to either (a) flexibly draw on spatial memory in order to plan efficient routes to goal locations, or (b) fall back on inefficient, but cognitively less-demanding, stimulus-response associations (i.e., habits). Using neuroimaging and behavioral measures, the investigators' protocol will test whether experimentally-induced stress leads individuals to bring fewer details about future locations to mind when route planning, and whether such restricted prospective thought ultimately biases participants towards relatively inflexible, habitual actions.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
85

participants targeted

Target at P50-P75 for not_applicable

Timeline
3mo left

Started Sep 2019

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress95%
Sep 2019Sep 2026

First Submitted

Initial submission to the registry

March 25, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 1, 2019

Completed
6 months until next milestone

Study Start

First participant enrolled

September 24, 2019

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

April 17, 2026

Status Verified

November 1, 2025

Enrollment Period

6.9 years

First QC Date

March 25, 2019

Last Update Submit

April 16, 2026

Conditions

Keywords

AgingSpatial MemoryStressfMRI

Outcome Measures

Primary Outcomes (3)

  • Behavioral probability of taking a shortcut between control and treatment groups

    Probability of taking a virtual navigation shortcut on an fMRI task trial, compared between stress and control groups. Measurement tool: objective categorical measure (no scale) reflecting proportion of trials in which participants traverse the shortcut road or, alternatively, the familiar (longer) road in a virtual environment.

    Approximately 1.5 years

  • fMRI activation level between control and treatment groups

    Network activation levels (across frontoparietal, hippocampal, and striatal memory network) during fMRI task trials, compared between stress and control groups. Measurement tool: fMRI activity level. Scale: continuous activity level estimates from fMRI.

    Approximately 1.5 years

  • Neural memory representation reactivation between control and treatment groups

    Memory reactivation levels in neural activity patterns during fMRI task, compared between stress and control groups. Measurement tool: Machine learning algorithm trained to decode fMRI patterns across voxels. Scale: algorithm success at classifying fMRI patterns according to the correct location memory for a given fMRI task trial

    Approximately 1.5 years

Secondary Outcomes (2)

  • Relationship between fMRI activity level and behavioral probability of taking a shortcut.

    Approximately 1.5 years

  • 2. Salivary cortisol (stress hormone) response difference between stress and control participant groups.

    Approximately 1.5 years

Study Arms (2)

No-stress control group

NO INTERVENTION

Participants in this group will perform the psychology tasks (virtual navigation) without any manipulation of psychological stress

Stress group

EXPERIMENTAL

Participants in this group will perform the psychology tasks (virtual navigation) under manipulated psychological stress (anticipatory threat of shock)

Behavioral: Anticipatory psychological stress

Interventions

Unpredictable delivery of low-level electrical stimulation to left ankle periodically throughout psychology tasks (virtual navigation). Established procedure for inducing anticipatory stress.

Stress group

Eligibility Criteria

Age65 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • adults 65-80
  • U.S. citizens or permanent residents
  • who speak fluent English
  • willing to come to Georgia Tech to participate in group testing sessions.

You may not qualify if:

  • Individuals will be carefully screened using IRB-approved procedures for safety contraindications to MRI and electrical shock stimulation
  • (e.g., metal or electrical implants, heart arrhythmia, or medication affecting the cardiovascular system \[e.g. beta-blockers\]).
  • Epilepsy
  • Dementia
  • Parkinson's disease
  • history of stroke or seizure
  • psychiatric disorders
  • untreated depression or emotional conditions
  • Attention Deficit Disorder
  • Multiple Sclerosis
  • uncontrolled hyper- or hypo-tension
  • untreated Diabetes
  • Sickle Cell Anemia
  • regularly use illegal or psychoactive drugs (e.g., cocaine, alcohol abuse, etc).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Advance Brain Imaging

Atlanta, Georgia, 30318, United States

RECRUITING

MeSH Terms

Conditions

Anxiety DisordersMemory Disorders

Condition Hierarchy (Ancestors)

Mental DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Thackery I Brown, Ph.D.

    Georgia Institute of Technology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Thackery I Brown, Ph.D.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Behavioral (Psychological stress manipulation). Between-subjects design. Participants will be assigned to either a stress-manipulated or control (no stress induced) group.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2019

First Posted

April 1, 2019

Study Start

September 24, 2019

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

April 17, 2026

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations