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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03896529




Registration number
NCT03896529
Ethics application status
Date submitted
25/03/2019
Date registered
1/04/2019

Titles & IDs
Public title
Neurobiological Mechanisms of Aging and Stress on Prospective Navigation
Scientific title
Neurobiological Mechanisms of Aging and Stress on Prospective Navigation
Secondary ID [1] 0 0
R21AG063131
Secondary ID [2] 0 0
H18233
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Aging 0 0
Anxiety 0 0
Memory Impairment 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BEHAVIORAL - Anticipatory psychological stress

No intervention: No-stress control group - Participants in this group will perform the psychology tasks (virtual navigation) without any manipulation of psychological stress

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


BEHAVIORAL: Anticipatory psychological stress
Unpredictable delivery of low-level electrical stimulation to left ankle periodically throughout psychology tasks (virtual navigation). Established procedure for inducing anticipatory stress.
Intervention code [1] 0 0
BEHAVIORAL
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Behavioral probability of taking a shortcut between control and treatment groups
Timepoint [1] 0 0
Approximately 1.5 years
Primary outcome [2] 0 0
fMRI activation level between control and treatment groups
Timepoint [2] 0 0
Approximately 1.5 years
Primary outcome [3] 0 0
Neural memory representation reactivation between control and treatment groups
Timepoint [3] 0 0
Approximately 1.5 years
Secondary outcome [1] 0 0
Relationship between fMRI activity level and behavioral probability of taking a shortcut.
Timepoint [1] 0 0
Approximately 1.5 years
Secondary outcome [2] 0 0
2. Salivary cortisol (stress hormone) response difference between stress and control participant groups.
Timepoint [2] 0 0
Approximately 1.5 years

Eligibility
Key inclusion criteria
* 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.
Minimum age
65 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* 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
* 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.

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
24/09/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/06/2025
Actual
Sample size
Target
85
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Georgia

Funding & Sponsors
Primary sponsor type
Other
Name
Georgia Institute of Technology
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Institute on Aging (NIA)
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Thackery I Brown, Ph.D.
Address 0 0
Georgia Institute of Technology
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Thackery I Brown, Ph.D.
Address 0 0
Country 0 0
Phone 0 0
404-894-1123
Fax 0 0
Email 0 0
thackery.brown@psych.gatech.edu
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03896529