AgingNCT03896529
Neurobiological Mechanisms of Aging and Stress on Prospective Navigation
A study testing Anticipatory psychological stress in people with Aging and Anxiety, run by Georgia Institute of Technology at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging, Anxiety, Memory Impairment
- What is being tested?
- Anticipatory psychological stress
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Sep 2019to 25 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 80 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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]).
- The purpose of this study is to investigate mechanisms of normally functioning memory, and memory-related changes in healthy aging. Thus, any confounding factors that may influence cognition, other than age, will be exclusionary. Potential participants that endorse any of the following conditions will be excluded from the study:
- Epilepsy
- Dementia
- Parkinson's disease
Show all 16Show fewer
- 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).
- Additionally, individuals scoring < 3 on WAIS-R forward span, < 2 on WAIS-R backward span, and failing to name more than 2 vegetable names will be excluded from the study. These exclusions will insure that persons with mild cognitive impairment or typical indications of clinical dementia will be not participate in the research.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Center for Advance Brain Imaging
Atlanta, Georgia, 30318
Vishwadeep Ahluwalia, Ph.D., 404-385-8619, vahluwalia7@gatech.edu
Brown Thackery, Ph.D
About this study
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.
Read the detailed description
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.
The investigators propose a study that utilizes cutting-edge imaging and virtual reality techniques to characterize the neural mechanisms of prospective (future goal-directed) navigational planning in aging. The investigators will use multi-voxel pattern analyses (MVPA) to obtain neural indices of memory-guided navigational planning. The investigators will then examine the mechanisms through which stress limits the ability of individuals to flexibly navigate to future goals. A critical aim will be to evaluate the neural bases for individual differences in navigational planning and the stress response, providing novel insight into convergent neurocognitive traits that underlie different degrees of age-related cognitive decline. The investigators predict that impaired prospective planning is associated with individual differences in (a) susceptibility to exogenous, experimentally-induced stress, and (b) stress-disrupted functioning of memory and attention and cognitive control networks necessary for mental simulation.
The investigators' proposal combines a novel immersive navigation paradigm, validated by the PI in healthy young adults, and an established between-subjects exogenous manipulation of psychological stress (see Research Strategy). 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). Participants will be pseudorandomly assigned to stress-manipulated or control groups, with an initial prospective random assignment of subject IDs being adjusted as recruitment progresses in order to enforce approximately equivalent age distributions in the two groups (and thus limit confounds in subsequent group comparisons). Salivary cortisol (stress hormone) assays (de-identified) will help validate the stress difference between groups. Leveraging MVPA, and trait questionnaires, the investigators' study 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.
Aging is associated with differences in the degree to which people rely on "map-like" spatial memory vs. procedural motor responses to traverse environments. Thus the investigators' investigation of the effects of stress on habitual vs. prospective spatial memory-guided navigation is embedded within the context of age-related differences in spatial memory processing in the investigators' target population. The investigators will further employ an endogenous navigational strategy identification task, enabling us to 1) establish a link between endogenous navigation strategy preferences and performance on the investigators' prospective navigation task, and 2) study how endogenous navigational strategy preferences interact with induced stress to affect the investigators' neural and behavioral outcome measures indexing efficient, prospective spatial cognition.
- Conditions
- Aging, Anxiety, Memory Impairment
- Being tested
- Anticipatory psychological stress
- Keywords
- Aging, Spatial Memory, Stress, fMRI
- Medical subject headings
- Anxiety Disorders, Memory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anticipatory psychological stressBehavioural
Unpredictable delivery of low-level electrical stimulation to left ankle periodically throughout psychology tasks (virtual navigation). Established procedure for inducing anticipatory stress.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Behavioral: Anticipatory psychological stress |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: Approximately 1.5 years
Secondary outcomes (2)
Relationship between fMRI activity level and behavioral probability of taking a shortcut.
A linear regression will relate continuous network activity levels (Outcome measure 2) across participants with proportion of virtual navigation shortcuts (shortcut vs familiar route; Outcome measure 1). Measurement tool: fMRI and objective categorical measure of route choice behavior during fMRI task.
Measured: Approximately 1.5 years
2. Salivary cortisol (stress hormone) response difference between stress and control participant groups.
A two-sample t-test will compare stress hormone levels (cortisol from saliva sample) between the stress and control groups. Measurement tool: cotton swab (salivette) assay of de-identified hormone levels in saliva during fMRI task.
Measured: Approximately 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2019
- Study start24 Sep 2019
- Primary completion25 Dec 2026 (estimated)
- Study completion25 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Behavioral (Psychological stress manipulation). Between-subjects design. Participants will be assigned to either a stress-manipulated or control (no stress induced) group.
- Masking
- None (open label)
- Enrolment
- 85 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Georgia Institute of Technology
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Thackery I Brown, Ph.D., Principal investigator, Georgia Institute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03896529
- Sponsor's protocol ID
- H18233
- Other IDs
- R21AG063131
- Status last verified
- Sep 2026
- First submitted
- 25 Mar 2019
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurobiological Mechanisms of Aging and Stress on Prospective Navigation
- ClinicalTrials.gov ID
- NCT03896529
- Acronym / sponsor ID
- H18233
- Conditions
- Aging, Anxiety, Memory Impairment
- Keywords
- Aging, Spatial Memory, Stress, fMRI
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- Georgia Institute of TechnologyUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 24 Sep 2019 (actual)
- Primary completion
- 25 Dec 2026 (estimated)
- Study completion
- 25 Dec 2026 (estimated)
- First posted
- 1 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
The investigators propose a study that utilizes cutting-edge imaging and virtual reality techniques to characterize the neural mechanisms of prospective (future goal-directed) navigational planning in aging. The investigators will use multi-voxel pattern analyses (MVPA) to obtain neural indices of memory-guided navigational planning. The investigators will then examine the mechanisms through which stress limits the ability of individuals to flexibly navigate to future goals. A critical aim will be to evaluate the neural bases for individual differences in navigational planning and the stress response, providing novel insight into convergent neurocognitive traits that underlie different degrees of age-related cognitive decline. The investigators predict that impaired prospective planning is associated with individual differences in (a) susceptibility to exogenous, experimentally-induced stress, and (b) stress-disrupted functioning of memory and attention and cognitive control networks necessary for mental simulation.
The investigators' proposal combines a novel immersive navigation paradigm, validated by the PI in healthy young adults, and an established between-subjects exogenous manipulation of psychological stress (see Research Strategy). 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). Participants will be pseudorandomly assigned to stress-manipulated or control groups, with an initial prospective random assignment of subject IDs being adjusted as recruitment progresses in order to enforce approximately equivalent age distributions in the two groups (and thus limit confounds in subsequent group comparisons). Salivary cortisol (stress hormone) assays (de-identified) will help validate the stress difference between groups. Leveraging MVPA, and trait questionnaires, the investigators' study 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.
Aging is associated with differences in the degree to which people rely on "map-like" spatial memory vs. procedural motor responses to traverse environments. Thus the investigators' investigation of the effects of stress on habitual vs. prospective spatial memory-guided navigation is embedded within the context of age-related differences in spatial memory processing in the investigators' target population. The investigators will further employ an endogenous navigational strategy identification task, enabling us to 1) establish a link between endogenous navigation strategy preferences and performance on the investigators' prospective navigation task, and 2) study how endogenous navigational strategy preferences interact with induced stress to affect the investigators' neural and behavioral outcome measures indexing efficient, prospective spatial cognition.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Behavioral (Psychological stress manipulation). Between-subjects design. Participants will be assigned to either a stress-manipulated or control (no stress induced) group.
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Anticipatory psychological stressParticipants in this group will perform the psychology tasks (virtual navigation) under manipulated psychological stress (anticipatory threat of shock) |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (16 listed)
- 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]).
- The purpose of this study is to investigate mechanisms of normally functioning memory, and memory-related changes in healthy aging. Thus, any confounding factors that may influence cognition, other than age, will be exclusionary. Potential participants that endorse any of the following conditions will be excluded from the study:
- Epilepsy
- Dementia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anticipatory psychological stressUnpredictable delivery of low-level electrical stimulation to left ankle periodically throughout psychology tasks (virtual navigation). Established procedure for inducing anticipatory stress. | Behavioural | Stress group |
Primary outcome
Behavioral probability of taking a shortcut between control and treatment groups
Time frame: Approximately 1.5 years
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.
fMRI activation level between control and treatment groups
Time frame: Approximately 1.5 years
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.
Neural memory representation reactivation between control and treatment groups
Time frame: Approximately 1.5 years
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
2 secondary outcomes
Relationship between fMRI activity level and behavioral probability of taking a shortcut.
Time frame: Approximately 1.5 years
2. Salivary cortisol (stress hormone) response difference between stress and control participant groups.
Time frame: Approximately 1.5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Thackery I Brown, Ph.D. principal investigator
Georgia Institute of Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anticipatory psychological stress in people with Aging and Anxiety, run by Georgia Institute of Technology at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thackery I Brown, Ph.D. (404-894-1123, thackery.brown@psych.gatech.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Behavioral probability of taking a shortcut between control and treatment groups (time frame: Approximately 1.5 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.