Motivation in Healthy Older AdultsNCT03197181
Frontopolar Cortex and Motivation in Healthy Older Adults
A study testing transcranial direct current stimulation in people with Motivation in Healthy Older Adults, run by University of Zurich at 1 site in Switzerland.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 65 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Motivation in Healthy Older Adults
- What is being tested?
- transcranial direct current stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteSwitzerland
- Study dates
- 16 Jan 2018to 30 Jun 2020
- Phase
- Interventional
- 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 65 to 80 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Motivation in Healthy Older Adults
- Being tested
- transcranial direct current stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial direct current stimulationDevice
Participants receive anodal or sham transcranial direct current stimulation while performing effort-based decision tasks.
| Study group | Role | What they receive |
|---|---|---|
| anodal transcranial direct current stimulation | Experimental | anodal transcranial direct current stimulation (current strength: 1 mA, duration: 20 min) over the frontopolar cortex Receives: Device: transcranial direct current stimulation |
| sham transcranial direct current stimulation | Sham comparator | sham transcranial direct current stimulation (current strength: 1 mA, duration: 0.5 min) over the frontopolar cortex Receives: Device: transcranial direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
participants' decisions to exert cognitive or physical effort for monetary rewards
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2017
- Study start16 Jan 2018
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Motivation in Healthy Older AdultsStudies of the same condition, open and under way.
- More trials run by University of ZurichThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- In two separate sessions, participants receive either anodal or sham transcranial direct current stimulation while the participants are performing a decision-making task on the computer.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe N Tobler, Prof., Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03197181
- Sponsor's protocol ID
- FPC-17-AGING-01
- Status last verified
- Apr 2021
- First submitted
- 20 Jun 2017
- Last updated
- 29 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 29 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Causal Role of Frontopolar Cortex for Motivation in Healthy Older Adults: a Transcranial Direct Current Stimulation Study
- ClinicalTrials.gov ID
- NCT03197181
- Acronym / sponsor ID
- FPC-17-AGING-01
- Conditions
- Motivation in Healthy Older Adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 16 Jan 2018 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 23 Jun 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.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- In two separate sessions, participants receive either anodal or sham transcranial direct current stimulation while the participants are performing a decision-making task on the computer.
| Arm | Type | Receives |
|---|---|---|
| anodal transcranial direct current stimulation | Experimental | Device: transcranial direct current stimulationanodal transcranial direct current stimulation (current strength: 1 mA, duration: 20 min) over the frontopolar cortex |
| sham transcranial direct current stimulation | Sham comparator | Device: transcranial direct current stimulationsham transcranial direct current stimulation (current strength: 1 mA, duration: 0.5 min) over the frontopolar cortex |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (12 listed)
- Negative response to TMS/tDCS in past
- History of seizure
- History of stroke or heart attack
- History of head injury
- Psychiatric or neurological disorder
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 |
|---|---|---|
| transcranial direct current stimulationParticipants receive anodal or sham transcranial direct current stimulation while performing effort-based decision tasks. | Device | anodal transcranial direct current stimulation, sham transcranial direct current stimulation |
Primary outcome
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.
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 29 Apr 2021.
- Individual participant dataSharing planned: No
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.
Philippe N Tobler, Prof. principal investigator
University of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcranial direct current stimulation in people with Motivation in Healthy Older Adults, run by University of Zurich at 1 site in Switzerland.
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 6 inclusion and 12 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 29 Apr 2021. 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 Switzerland. 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. Some participants in this study may receive a placebo. 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?
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.). 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 29 Apr 2021.