Healthy AgingNCT03341611
The Effect of Aging on Value Based Decision-making
An observational study of Healthy Aging, run by University of Southern California at 1 site in United States.
Trial summary
The investigators propose to study the effect of aging on the neural circuitry involved in valuation and value reasoning and to relate it to choice anomalies and inconsistencies. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Aging
- What is being tested?
- Neuro-imaging during behavioral decision-making task
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2016to 30 Apr 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy adults above 18yo
Who may be able to join
- Healthy adults
Who cannot join
- 1- Subjects under 18yo . 2- Subjects with known cognitive disorders 3- Subjects with visual or auditory deficits that would interfere with the ability to complete the experimental tasks.
- 4- Subjects reporting having metal implants 5- Subjects with a history of major anxiety disorder or other major psychiatric condition, 6- Subjects with a documented or subjectively reported claustrophobia. 7- Subjects thinking they are or may be pregnant. 8- Subjects with a history of head trauma that resulted in loss of consciousness for more than 5 minutes.
- 9-Hx of seizures 10-Left Handed 11- On any medications affecting cognition 12- For tasks involving foods: a) Currently on diet and or b) any known food allergies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Neuroeconomic Study of Choice Consistency in Aging
The investigators propose to study the effect of aging on the neural circuitry involved in valuation and value reasoning and to relate it to choice anomalies and inconsistencies. Quantifying and characterizing valuation-based decision-making deficits in older adults, and their relationship to the aging brain, can inform and facilitate intervention - both at the level of the individual and at the level of policy.
Read the detailed description
The attribution of value to prospects is a fundamental element of decision-making, as most day-to-day decisions involve comparing items. Studies on aging document behaviors reflecting difficulties in making comparisons between options, in particular when those options are complex. Given the growing complexity of economic products (insurance, savings, mortgages or even telephone plans), older adults may have difficulty making decisions that accurately reflect their underlying preferences. It is plausible that this difficulty is linked to age-related brain function decline within sectors of the lateral prefrontal cortex implicated in working memory and cognitive control. This study assesses age-related changes in how the brain computes value and makes value comparisons using a well-established economic paradigm, the "generalized axiom of revealed preference" (GARP) Task, that tests the internal consistency of a subject's preferences by offering repeated choices between bundles of goods. A preliminary study suggests that aging is associated with greater GARP-Task inconsistency. Although the neural correlates of GARP inconsistency have not been directly established, indirect evidence suggests that the medial orbitofrontal cortex is important in all value-based decision-making, and that areas in the lateral prefrontal and parietal cortices (fronto-parietal network) are important for maintaining consistency in complex decisions (e.g., multi-attribute decisions). Aging is associated with structural and functional deficits within the fronto-parietal network. Therefore, the investigators believe that studying the neural correlates of the GARP-Task is a promising approach to investigate decision-making deficits in aging. The investigators will recruit 45 young adults, and 45 old adults. Participants will complete the GARP-Task and an functional Magnetic resonance imaging (fMRI) variant designed to isolate neural correlates of valuation of single items, of multiple instances of the same item ("scaling") and of sets of distinct items ("bundles"). Brain activity will be related to diagnosis and to variance in GARP-Task inconsistency. Given the prominence of age-related decline in working memory, the investigators hypothesize that age will be associated with higher GARP-Task inconsistency and to deficits in conditions that require manipulation of value signals (scaling and bundles). The investigators anticipate that these deficits will be associated with low recruitment within the fronto-parietal network and with reduced functional connectivity between this network and the medial Orbitofrontal Cortex (OFC).
- Conditions
- Healthy Aging
- Being tested
- Neuro-imaging during behavioral decision-making task
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuro-imaging during behavioral decision-making taskBehavioural
All participants will make simple decisions while in a scanner.
| Study group | Role | What they receive |
|---|---|---|
| Adults 55 and younger | Not described Receives: Behavioral: Neuro-imaging during behavioral decision-making task | |
| Adults 55 and older | Not described Receives: Behavioral: Neuro-imaging during behavioral decision-making task |
What is being measured
The primary outcome is the main question the study is designed to answer.
Computerized behavioral choice task
The task consists in 450 trials. In each trial, the participant needs to choose between food items presented on a computer screen. Frequency of choices is used to assess the ranking (or value) of these food items and inconsistencies in choices are recorded. Food items vary in complexity (from single items to complex bundles).
Measured: 2 hours
Brain imaging to track brain regions involving in value
fMRI images are collected during part of the behavioral choice task. Behavioral measures are used to track value encoding as well as inconsistent choices in the brain (as a function of item complexity). These data are eventually aggregated across participants in each condition (using standard methods) to identify the regions of interest involved in our experiment.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2017
- Study start1 Jan 2016
- Primary completion30 Apr 2018
- Study completion30 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AgingStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Isabelle Brocas, University of Southern California
- Investigators
- Isabelle Brocas, PhD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03341611
- Sponsor's protocol ID
- 1R21AG046917-01A1
- Status last verified
- May 2019
- First submitted
- 6 Nov 2017
- Last updated
- 22 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will share all data and results.
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Neuroeconomic Study of Choice Consistency in Aging
- ClinicalTrials.gov ID
- NCT03341611
- Acronym / sponsor ID
- 1R21AG046917-01A1
- Conditions
- Healthy Aging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 30 Apr 2018 (actual)
- Study completion
- 30 Apr 2018 (actual)
- First posted
- 14 Nov 2017 (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.
The investigators propose to study the effect of aging on the neural circuitry involved in valuation and value reasoning and to relate it to choice anomalies and inconsistencies. Quantifying and characterizing valuation-based decision-making deficits in older adults, and their relationship to the aging brain, can inform and facilitate intervention - both at the level of the individual and at the level of policy.
Detailed description
The attribution of value to prospects is a fundamental element of decision-making, as most day-to-day decisions involve comparing items. Studies on aging document behaviors reflecting difficulties in making comparisons between options, in particular when those options are complex. Given the growing complexity of economic products (insurance, savings, mortgages or even telephone plans), older adults may have difficulty making decisions that accurately reflect their underlying preferences. It is plausible that this difficulty is linked to age-related brain function decline within sectors of the lateral prefrontal cortex implicated in working memory and cognitive control. This study assesses age-related changes in how the brain computes value and makes value comparisons using a well-established economic paradigm, the "generalized axiom of revealed preference" (GARP) Task, that tests the internal consistency of a subject's preferences by offering repeated choices between bundles of goods. A preliminary study suggests that aging is associated with greater GARP-Task inconsistency. Although the neural correlates of GARP inconsistency have not been directly established, indirect evidence suggests that the medial orbitofrontal cortex is important in all value-based decision-making, and that areas in the lateral prefrontal and parietal cortices (fronto-parietal network) are important for maintaining consistency in complex decisions (e.g., multi-attribute decisions). Aging is associated with structural and functional deficits within the fronto-parietal network. Therefore, the investigators believe that studying the neural correlates of the GARP-Task is a promising approach to investigate decision-making deficits in aging. The investigators will recruit 45 young adults, and 45 old adults. Participants will complete the GARP-Task and an functional Magnetic resonance imaging (fMRI) variant designed to isolate neural correlates of valuation of single items, of multiple instances of the same item ("scaling") and of sets of distinct items ("bundles"). Brain activity will be related to diagnosis and to variance in GARP-Task inconsistency. Given the prominence of age-related decline in working memory, the investigators hypothesize that age will be associated with higher GARP-Task inconsistency and to deficits in conditions that require manipulation of value signals (scaling and bundles). The investigators anticipate that these deficits will be associated with low recruitment within the fronto-parietal network and with reduced functional connectivity between this network and the medial Orbitofrontal Cortex (OFC).
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adults 55 and younger | – | Behavioral: Neuro-imaging during behavioral decision-making task |
| Adults 55 and older | – | Behavioral: Neuro-imaging during behavioral decision-making task |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy adults above 18yo
Key inclusion criteria (1 listed)
- Healthy adults
Key exclusion criteria (3 listed)
- 1- Subjects under 18yo . 2- Subjects with known cognitive disorders 3- Subjects with visual or auditory deficits that would interfere with the ability to complete the experimental tasks.
- 4- Subjects reporting having metal implants 5- Subjects with a history of major anxiety disorder or other major psychiatric condition, 6- Subjects with a documented or subjectively reported claustrophobia. 7- Subjects thinking they are or may be pregnant. 8- Subjects with a history of head trauma that resulted in loss of consciousness for more than 5 minutes.
- 9-Hx of seizures 10-Left Handed 11- On any medications affecting cognition 12- For tasks involving foods: a) Currently on diet and or b) any known food allergies
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 |
|---|---|---|
| Neuro-imaging during behavioral decision-making taskAll participants will make simple decisions while in a scanner. | Behavioural | Adults 55 and older, Adults 55 and younger |
Primary outcome
Computerized behavioral choice task
Time frame: 2 hours
The task consists in 450 trials. In each trial, the participant needs to choose between food items presented on a computer screen. Frequency of choices is used to assess the ranking (or value) of these food items and inconsistencies in choices are recorded. Food items vary in complexity (from single items to complex bundles).
Brain imaging to track brain regions involving in value
Time frame: 1 hour
fMRI images are collected during part of the behavioral choice task. Behavioral measures are used to track value encoding as well as inconsistent choices in the brain (as a function of item complexity). These data are eventually aggregated across participants in each condition (using standard methods) to identify the regions of interest involved in our experiment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2019.
- Individual participant dataSharing planned: Yes. We will share all data and results.
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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. This study is not recruiting at the moment.
Isabelle Brocas, PhD principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Aging, run by University of Southern California 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 1 inclusion and 3 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: finished, as of the sponsor's last update on 22 May 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Computerized behavioral choice task (time frame: 2 hours). The study lists 2 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 22 May 2019.