Frontopolar Cortex and Motivation in Healthy Older Adults

April 27, 2021 updated by: University of Zurich

Causal Role of Frontopolar Cortex for Motivation in Healthy Older Adults: a Transcranial Direct Current Stimulation Study

Motivation represents a core aspect of goal-directed behavior as it determines how much effort individuals are willing to invest to reach their goals. While research on effort-based decision-making focuses mainly on effort preferences in younger adults, loss of motivation might be a key component of the apathetic tendencies frequently seen in older adults. However, an open question refers to which brain mechanisms underlie motivational processes in older adults. The investigators have recently shown that the frontopolar cortex plays a crucial in motivating the exertion of rewarded effort in younger adults. The goal of the current study is to determine whether frontopolar cortex plays a crucial role for motivation also in older adults and may thus be a promising target for improving the motivation deficits in healthy aging. Participants perform computer-based experimental tasks measuring the propensity to exert cognitive or physical effort for monetary rewards. During task performance, participants receive anodal or sham transcranial direct current stimulation (tDCS) over their frontopolar cortex. The study tests whether tDCS over frontopolar cortex allows modulating participants' motivation to engage in rewarded effort.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Motivation represents a core aspect of goal-directed behavior as it determines how much effort individuals are willing to invest to reach their goals. While research on effort-based decision-making focuses mainly on effort preferences in younger adults, loss of motivation might be a key component of the apathetic tendencies frequently seen in older adults. However, an open question refers to which brain mechanisms underlie motivational processes in older adults. The investigators have recently shown that the frontopolar cortex plays a crucial in motivating the exertion of rewarded effort in younger adults (Soutschek et al., 2018, Biological Psychiatry). The goal of the current study is to determine whether frontopolar cortex plays a crucial role for motivation also in older adults and may thus be a promising target for improving the motivation deficits in healthy aging. 30 older participants (65-80 years) perform computer-based experimental tasks measuring the propensity to exert cognitive or physical effort for monetary rewards. During task performance, participants receive 1 mA anodal or sham transcranial direct current stimulation (tDCS) over their frontopolar cortex. The study tests whether tDCS over frontopolar cortex allows modulating participants' motivation to engage in rewarded effort.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
26

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Zürich, Switzerland, 8006
        • University of Zurich

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

65 years to 80 years (OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 65-80 years
  • Informed consent as documented by signature
  • Normal or corrected-to-normal vision
  • Cognitive and language ability to understand study content and procedure
  • Normal cognitive functioning (assessed by MMST)
  • BDI-II score < 20

Exclusion Criteria:

  • Negative response to TMS/tDCS in past
  • History of seizure
  • History of stroke or heart attack
  • History of head injury
  • Psychiatric or neurological disorder
  • Metal in body/head
  • Implanted medical products like pacemaker, medical pumps, heart catheter
  • Headache
  • Tinnitus
  • Currently taking medication affecting the central nervous system
  • Insufficient sleep in preceding night
  • Excessive consumption of alcohol within last 24 hours

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: anodal transcranial direct current stimulation
anodal transcranial direct current stimulation (current strength: 1 mA, duration: 20 min) over the frontopolar cortex
Device: transcranial direct current stimulation
Participants receive anodal or sham transcranial direct current stimulation while performing effort-based decision tasks.
SHAM_COMPARATOR: sham transcranial direct current stimulation
sham transcranial direct current stimulation (current strength: 1 mA, duration: 0.5 min) over the frontopolar cortex
Device: transcranial direct current stimulation
Participants receive anodal or sham transcranial direct current stimulation while performing effort-based decision tasks.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
participants' decisions to exert cognitive or physical effort for monetary rewards
Time Frame: All participants perform this decision-making task in both experimental sessions (i.e., both the anodal and the sham stimulation session) for 20 min while receiving anodal or sham stimulation.
The project seeks to test the causal role of FPC in discounting of cognitive and physical effort in healthy older adults. For that purpose, participants perform a task on a computer which requires the participants to decide whether the participants are willing to exert cognitive or physical effort for a monetary reward. Participants perform this task both under anodal and under sham stimulation. It is tested whether anodal, relative to sham, stimulation increases participants' willingness to engage in rewarded cognitive or physical effort.
All participants perform this decision-making task in both experimental sessions (i.e., both the anodal and the sham stimulation session) for 20 min while receiving anodal or sham stimulation.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Zurich

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Philippe N Tobler, Prof., University of Zurich

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 16, 2018

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2020

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 20, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 21, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 23, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 29, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 27, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FPC-17-AGING-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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