fMRI ResearchEffortLESSNCT06691490
The Relationships Between Neural Correlates of Effort Perception and Physical Activity Engagement
A study of fMRI Research and Transcranial Magnetic Stimilation, run by University Hospital, Grenoble at 1 site in France.
Trial summary
Objectives and research hypothesis Physical inactivity is a major health concern that has been linked to a variety of chronic diseases, including obesity, diabetes, cancer, cardiovascular diseases, and mental disorders. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- fMRI Research, Transcranial Magnetic Stimilation, EEG Brain Oscillations
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 13 Feb 2025to Nov 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Normal subjects all ranges age
Who cannot join
- Neurologic conditions that may bias the EEG or fMRI results such as epilepsy, tumors; stroke; which can be a casual MRI finding during the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Plateforme IRMaGe
La Tronche, 38700
Emilie COUSIN, 0476825876, emilie.cousin@univ-grenoble-alpes.fr
Florian MONJO
About this study
Official title: Functional MRI Protocols for Studying the Neural Correlates of Effort Perception and the Effects of Targeted rTMS Protocols on Perceived Effort and Effort-based Decision-making
Objectives and research hypothesis Physical inactivity is a major health concern that has been linked to a variety of chronic diseases, including obesity, diabetes, cancer, cardiovascular diseases, and mental disorders. Recent studies have shown that regular physical activity can decrease the risk of SARS-CoV-2 infection, and severe COVID-19 illnesses, as well as improve antibody response to vaccine. As such, the adoption of a physically active lifestyle carries potential health benefits and has even been referred to as a "miracle cure" by the Academy of Royal Medical Colleges. Despite the implementation of policies that aimed to encourage regular physical activity, the prevalence of insufficient physical activity in high-income countries has increased since 2001 (32% in 2001 vs. 37% in 2018). Given the limited impact of health policies on physical activity engagement, it is essential to explore other avenues of research that can contribute to understanding this high level of inactivity and driving innovative strategies for encouraging physical activity. In this context, the automatic attraction of individuals toward activities associated with low-effort exertion is thought to play a key role in physical inactivity. Physical activity involves exerting physical effort, i.e., intensifying physical energy to achieve certain goals, such as increasing the force to lift a heavy object. This physical intensification is associated with the phenomenological experience of energy exertion. Higher effort perception is thought to be aversively valued by inactive individuals, inhibiting their engagement in regular physical activity. However, there is a lack of knowledge regarding the neural correlates of effort perception and how they relate to physical inactivity. It is crucial to gain insights into these neural correlates, especially to enhance our comprehension of the significance of effort minimization in physical inactivity. This project aims to decrease effort perception and improve the valuation of effort, incentivize regular physical activity, and improve overall health outcomes.
Objective 1. Despite ongoing research, there is a lack of agreement on the neural mechanisms underlying effort perception as well as the role of sensorial feedback. Tasks EEG and fMRI aim to address this issue with original experimental methods in order to identify this neural mechanism.
Read more
Hypothesis 1. Following A) muscle vibration and B) Induced ischemic paralysis and anesthesia, we expect decreased effort perception associated with a lower cortical S1 activation, unchanged activation in premotor structures, and preserved functional connectivity between premotor regions and S1.
Objective 2. To unravel the neural interaction between efference copy and reafferent muscle spindle signals that contribute to effort perception Hypothesis 2. The neural correlates of effort perception involve interactions between premotor and sensory brain structures. Neural activation patterns of the brain regions implicated in effort perception vary depending on an individual's inclination to engage in physical activity.
Objective 3. Task 3 will examine the potential of non-invasive brain stimulation techniques (TMS) to reduce effort perception in turn increase its perceived value quantified with the CR100 scale, the outcome variable of this study.
Hypothesis 3. Vibration-induced desensitization of muscle spindles and the SMA cTBS reduce effort perception and improve the subjective value of physical effort.
Read the detailed description
Our society is currently facing a pandemic of physical inactivity that is responsible for numerous chronic diseases and deaths. Despite the implementation of policies aimed at encouraging regular physical activity, the prevalence of physical inactivity remains high. It then seems necessary to explore other areas of research that could explain this level of inactivity and guide the implementation of new strategies to make the population more active. In this context, the tendency of most individuals to gravitate towards activities associated with a low perception of effort seems to play a central role in many barriers to engaging in physical activity. The perception of effort, which refers to the perception of the physical resources invested in a physical task, seems to be evaluated aversively by inactive individuals, limiting their engagement in physical activity. However, the neuropsychological bases of effort perception and how they are involved in physical inactivity remain poorly understood today. Therefore, clarifying the neural substrates involved in this perception and understanding how they determine engagement in physical activity is essential to help increase the population's level of physical activity. The hypothesis guiding this project is that reducing the perception of effort so that a particular intensity physical activity is perceived as less demanding facilitates engagement and the maintenance of a physically active lifestyle. In this context, the primary objective of this project will be to clarify the neural substrates involved in the perception of effort through a functional MRI study and to identify whether neuropsychological mechanisms related to the perception of effort differentiate individuals who have an aversion or an attraction to physical activity. Based on these results, the second objective will be to evaluate whether repetitive transcranial magnetic stimulation techniques targeting key nerve structures and reducing the perception of effort improve the value of effort and engagement in regular physical activity.
- Conditions
- fMRI Research, Transcranial Magnetic Stimilation, EEG Brain Oscillations, Motor Task, Ischemic Nerve Block (INB), Muscle Vibration Protocol
- Being tested
- Transcranial Magnetic Stimulation Sham
- Keywords
- Perception of effort
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Magnetic Stimulation ShamDevice
cTBS over SMA and cTBS over precuneus (control site)
| Study group | Role | What they receive |
|---|---|---|
| Transcranial Magnetic Stimulation Sham | Experimental | Participants will engage in 4 cycling exercise visits and 4 effort-discounting task visits. Each of these 8 visits will be associated with one of the 4 stimulation conditions: vibration condition, sham vibration condition, cTBS over SMA. These 8 visits will be randomized across participant Receives: Device: Transcranial Magnetic Stimulation Sham |
| TMS | Placebo comparator | cTBS over precuneus (control site). Receives: Device: Transcranial Magnetic Stimulation Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effort perception
Physical effort scale Category (C)-Ratio (R) (CR) scaling 100 or Borg centiMax® Scale (CR100) is a measure from 0 to 100 to rate the intensity of effort perception, where 0 means "nothing at all" (i.e. "no perception of effort at all") and 100 means "Maximal", that is, the maximal perception of effort experienced.
Measured: From enrollment up to 12 months after
Secondary outcomes (2)
Resting-state and task fMRI functional connectivity
Task fMRI condition A) induce ischemic paralysis and anesthesia: an MRI-compatible two chamber cuff will be placed over participants' upper arm outside the scanner and inflated to 250 mmHg until total abolishment of light touch sensation below the elbow is achieved46. This generally takes 20-40 min B) Task fMRI control condition. They will perform voluntary isometric handgrip contractions at moderate and strong perceived effort intensities based on the CR100 with their dominant hand. These two intensities were chosen to assess the impact of perceived effort level on brain activity, while avoiding excessive head movement that could occur at higher intensities and controlling for the development of neuromuscular fatigue C) Resting-state fMRI: 10-min resting-state fMRI scan to assess functional connectivity between different brain regions.
Measured: From enrollment to 15 weeks after 60 healthy subjects will be assessed (4 subjects per week)
EEG event related synchronization
ERSP analyses will allow us to examine changes in alpha (8-13 Hz) and beta (13-30 Hz) neural oscillations within predetermined regions of interest during spindle desensitization. This will be done trougth the application of vibration at the myotendinous junction of the biceps brachii using a custom-made vibrator. Following the successful methodology of the PI in PoC1 and 2, we will apply the vibration for a 10-min period with a frequency of 100 Hz and an amplitude of approximately 2 mm in the vibration condition.
Measured: From enrollment to 40 weeks after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2024
- Study start13 Feb 2025
- Primary completionJul 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for fMRI ResearchStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe 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
- Parallel groups
- Model description
- Effort Perception; fMRI; EEG; Networks; Propioception
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- IRMage
- Responsible party
- Sponsor
- Investigators
- Florian MONJO, Principal investigator, Université de Chambéry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06691490
- Sponsor's protocol ID
- 38RC23.0416
- Acronym
- EffortLESS
- Status last verified
- Feb 2025
- First submitted
- 7 Nov 2024
- Last updated
- 20 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be stored in a secure server (NetExplorer, managed by the SFRI of the USMB). Access to the database will be limited with specific rights assigned to the different people involved in the project. Data extraction will automatically de-identified data
Publications
Pageaux B. Perception of effort in Exercise Science: Definition, measurement and perspectives. Eur J Sport Sci. 2016 Nov;16(8):885-94. doi: 10.1080/17461391.2016.1188992. Epub 2016 May 30.
PubMed 27240002Inzlicht M, Shenhav A, Olivola CY. The Effort Paradox: Effort Is Both Costly and Valued. Trends Cogn Sci. 2018 Apr;22(4):337-349. doi: 10.1016/j.tics.2018.01.007. Epub 2018 Feb 21.
PubMed 29477776Hallam J, Jones T, Alley J, Kohut ML. Exercise after influenza or COVID-19 vaccination increases serum antibody without an increase in side effects. Brain Behav Immun. 2022 May;102:1-10. doi: 10.1016/j.bbi.2022.02.005. Epub 2022 Feb 5.
PubMed 35131444Christensen MS, Lundbye-Jensen J, Geertsen SS, Petersen TH, Paulson OB, Nielsen JB. Premotor cortex modulates somatosensory cortex during voluntary movements without proprioceptive feedback. Nat Neurosci. 2007 Apr;10(4):417-9. doi: 10.1038/nn1873. Epub 2007 Mar 18.
PubMed 17369825Cheval B, Sieber S, Maltagliati S, Millet GP, Formanek T, Chalabaev A, Cullati S, Boisgontier MP. Muscle strength is associated with COVID-19 hospitalization in adults 50 years of age or older. J Cachexia Sarcopenia Muscle. 2021 Oct;12(5):1136-1143. doi: 10.1002/jcsm.12738. Epub 2021 Aug 6.
PubMed 34363345Cheval B, Boisgontier MP. The Theory of Effort Minimization in Physical Activity. Exerc Sport Sci Rev. 2021 Jul 1;49(3):168-178. doi: 10.1249/JES.0000000000000252.
PubMed 34112744
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional MRI Protocols for Studying the Neural Correlates of Effort Perception and the Effects of Targeted rTMS Protocols on Perceived Effort and Effort-based Decision-making
- ClinicalTrials.gov ID
- NCT06691490
- Acronym / sponsor ID
- EffortLESS / 38RC23.0416
- Conditions
- fMRI Research, Transcranial Magnetic Stimilation, EEG Brain Oscillations, Motor Task, Ischemic Nerve Block (INB), Muscle Vibration Protocol
- Keywords
- Perception of effort
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- IRMage
- Study start
- 13 Feb 2025 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 15 Nov 2024 (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.
Objectives and research hypothesis Physical inactivity is a major health concern that has been linked to a variety of chronic diseases, including obesity, diabetes, cancer, cardiovascular diseases, and mental disorders. Recent studies have shown that regular physical activity can decrease the risk of SARS-CoV-2 infection, and severe COVID-19 illnesses, as well as improve antibody response to vaccine. As such, the adoption of a physically active lifestyle carries potential health benefits and has even been referred to as a "miracle cure" by the Academy of Royal Medical Colleges. Despite the implementation of policies that aimed to encourage regular physical activity, the prevalence of insufficient physical activity in high-income countries has increased since 2001 (32% in 2001 vs. 37% in 2018). Given the limited impact of health policies on physical activity engagement, it is essential to explore other avenues of research that can contribute to understanding this high level of inactivity and driving innovative strategies for encouraging physical activity. In this context, the automatic attraction of individuals toward activities associated with low-effort exertion is thought to play a key role in physical inactivity. Physical activity involves exerting physical effort, i.e., intensifying physical energy to achieve certain goals, such as increasing the force to lift a heavy object. This physical intensification is associated with the phenomenological experience of energy exertion. Higher effort perception is thought to be aversively valued by inactive individuals, inhibiting their engagement in regular physical activity. However, there is a lack of knowledge regarding the neural correlates of effort perception and how they relate to physical inactivity. It is crucial to gain insights into these neural correlates, especially to enhance our comprehension of the significance of effort minimization in physical inactivity. This project aims to decrease effort perception and improve the valuation of effort, incentivize regular physical activity, and improve overall health outcomes.
Objective 1. Despite ongoing research, there is a lack of agreement on the neural mechanisms underlying effort perception as well as the role of sensorial feedback. Tasks EEG and fMRI aim to address this issue with original experimental methods in order to identify this neural mechanism.
Hypothesis 1. Following A) muscle vibration and B) Induced ischemic paralysis and anesthesia, we expect decreased effort perception associated with a lower cortical S1 activation, unchanged activation in premotor structures, and preserved functional connectivity between premotor regions and S1.
Objective 2. To unravel the neural interaction between efference copy and reafferent muscle spindle signals that contribute to effort perception Hypothesis 2. The neural correlates of effort perception involve interactions between premotor and sensory brain structures. Neural activation patterns of the brain regions implicated in effort perception vary depending on an individual's inclination to engage in physical activity.
Objective 3. Task 3 will examine the potential of non-invasive brain stimulation techniques (TMS) to reduce effort perception in turn increase its perceived value quantified with the CR100 scale, the outcome variable of this study.
Hypothesis 3. Vibration-induced desensitization of muscle spindles and the SMA cTBS reduce effort perception and improve the subjective value of physical effort.
Detailed description
Our society is currently facing a pandemic of physical inactivity that is responsible for numerous chronic diseases and deaths. Despite the implementation of policies aimed at encouraging regular physical activity, the prevalence of physical inactivity remains high. It then seems necessary to explore other areas of research that could explain this level of inactivity and guide the implementation of new strategies to make the population more active. In this context, the tendency of most individuals to gravitate towards activities associated with a low perception of effort seems to play a central role in many barriers to engaging in physical activity. The perception of effort, which refers to the perception of the physical resources invested in a physical task, seems to be evaluated aversively by inactive individuals, limiting their engagement in physical activity. However, the neuropsychological bases of effort perception and how they are involved in physical inactivity remain poorly understood today. Therefore, clarifying the neural substrates involved in this perception and understanding how they determine engagement in physical activity is essential to help increase the population's level of physical activity. The hypothesis guiding this project is that reducing the perception of effort so that a particular intensity physical activity is perceived as less demanding facilitates engagement and the maintenance of a physically active lifestyle. In this context, the primary objective of this project will be to clarify the neural substrates involved in the perception of effort through a functional MRI study and to identify whether neuropsychological mechanisms related to the perception of effort differentiate individuals who have an aversion or an attraction to physical activity. Based on these results, the second objective will be to evaluate whether repetitive transcranial magnetic stimulation techniques targeting key nerve structures and reducing the perception of effort improve the value of effort and engagement in regular physical activity.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Effort Perception; fMRI; EEG; Networks; Propioception
| Arm | Type | Receives |
|---|---|---|
| Transcranial Magnetic Stimulation Sham | Experimental | Device: Transcranial Magnetic Stimulation ShamParticipants will engage in 4 cycling exercise visits and 4 effort-discounting task visits. Each of these 8 visits will be associated with one of the 4 stimulation conditions: vibration condition, sham vibration condition, cTBS over SMA. These 8 visits will be randomized across participant |
| TMS | Placebo comparator | Device: Transcranial Magnetic Stimulation ShamcTBS over precuneus (control site). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Normal subjects all ranges age
Key exclusion criteria (1 listed)
- Neurologic conditions that may bias the EEG or fMRI results such as epilepsy, tumors; stroke; which can be a casual MRI finding during the study.
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 Magnetic Stimulation ShamcTBS over SMA and cTBS over precuneus (control site) | Device | TMS, Transcranial Magnetic Stimulation Sham |
Primary outcome
Effort perception
Time frame: From enrollment up to 12 months after
Physical effort scale Category (C)-Ratio (R) (CR) scaling 100 or Borg centiMax® Scale (CR100) is a measure from 0 to 100 to rate the intensity of effort perception, where 0 means "nothing at all" (i.e. "no perception of effort at all") and 100 means "Maximal", that is, the maximal perception of effort experienced.
2 secondary outcomes
Resting-state and task fMRI functional connectivity
Time frame: From enrollment to 15 weeks after 60 healthy subjects will be assessed (4 subjects per week)
EEG event related synchronization
Time frame: From enrollment to 40 weeks after
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 20 Feb 2025.
- Background: PubMed 27240002Pageaux B. Perception of effort in Exercise Science: Definition, measurement and perspectives. Eur J Sport Sci. 2016 Nov;16(8):885-94. doi: 10.1080/17461391.2016.1188992. Epub 2016 May 30.
- Background: PubMed 29477776Inzlicht M, Shenhav A, Olivola CY. The Effort Paradox: Effort Is Both Costly and Valued. Trends Cogn Sci. 2018 Apr;22(4):337-349. doi: 10.1016/j.tics.2018.01.007. Epub 2018 Feb 21.
- Background: PubMed 35131444Hallam J, Jones T, Alley J, Kohut ML. Exercise after influenza or COVID-19 vaccination increases serum antibody without an increase in side effects. Brain Behav Immun. 2022 May;102:1-10. doi: 10.1016/j.bbi.2022.02.005. Epub 2022 Feb 5.
- Background: PubMed 17369825Christensen MS, Lundbye-Jensen J, Geertsen SS, Petersen TH, Paulson OB, Nielsen JB. Premotor cortex modulates somatosensory cortex during voluntary movements without proprioceptive feedback. Nat Neurosci. 2007 Apr;10(4):417-9. doi: 10.1038/nn1873. Epub 2007 Mar 18.
- Background: PubMed 34363345Cheval B, Sieber S, Maltagliati S, Millet GP, Formanek T, Chalabaev A, Cullati S, Boisgontier MP. Muscle strength is associated with COVID-19 hospitalization in adults 50 years of age or older. J Cachexia Sarcopenia Muscle. 2021 Oct;12(5):1136-1143. doi: 10.1002/jcsm.12738. Epub 2021 Aug 6.
- Background: PubMed 34112744Cheval B, Boisgontier MP. The Theory of Effort Minimization in Physical Activity. Exerc Sport Sci Rev. 2021 Jul 1;49(3):168-178. doi: 10.1249/JES.0000000000000252.
- Individual participant dataSharing planned: Yes. The data will be stored in a secure server (NetExplorer, managed by the SFRI of the USMB). Access to the database will be limited with specific rights assigned to the different people involved in the project. Data extraction will automatically de-identified data
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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.
Florian MONJO principal investigator
Université de Chambéry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of fMRI Research and Transcranial Magnetic Stimilation, run by University Hospital, Grenoble at 1 site in France.
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 1 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 20 Feb 2025. 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 France. 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?
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 Florian MONJO (0479758123, florian.monjo@univ-smb.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effort perception (time frame: From enrollment up to 12 months after). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06691490, which also lists 6 linked publications.
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 20 Feb 2025.