StrokeMOTI-strokeNCT03741140
Characterizing the Neural Bases of Motivational Disorders After Stroke
A study testing Motivation tests in people with Stroke, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
Trial summary
The aim of the study is to quantify elementary mechanisms of motivation, with innovative tools adapted to clinical settings, in healthy subjects, and in stroke patients. The secondary aim of the study is to investigate the neural substrates of motivational mechanisms, and to study the impact of lesions in the grey and… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- Motivation tests
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteFrance
- Study dates
- 22 Oct 2020to 30 Jun 2022
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Right-handed
- Age > 18 years old
- Able to squeeze a hand-grip
- Signature of consent form
- Affiliation to an Health Insurance Scheme or beneficiary of such a scheme
- Age > 18 years old
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- Able to squeeze a hand-grip
- Signature of consent form
- Affiliation to an Health Insurance Scheme or beneficiary of such a scheme
- Stroke of the medial frontal lobe and not affecting the lateral frontal lobe OR stroke of the lateral frontal lobe and not affecting the medial frontal lobe
Who cannot join
- Under justice protection
- History of neurological or psychiatric diseases
- Evolving disease that could impede volunteer participation during the whole study
- Ongoing psychotropic drug or stopped for less than 3 weeks
- Treatment that could interfere with subject performance
- Chronical use of illicit psychoactive drugs or the day of the exam
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- Pregnant, parturient or breastfeeding woman
- Contra-indication to MRI scan
- Comprehension difficulties or difficulties to perform the study cognitive tests
- Under justice protection
- Evolving disease that could impede volunteer participation during the whole study
- Chronical use of illicit psychoactive drugs or the day of the exam
- Pregnant, parturient or breastfeeding woman
- Contra-indication to MRI scan
- Comprehension difficulties or difficulties to perform the study cognitive tests
- Brain sequela with important cognitive deficiencies preventing cognitive test interpretation according to the investigator
Trial locations and contacts
1 site in 1 country.
France1 site
Urgences cérébro-vasculaires hopital Pitié-Salpêtrière
Paris, 75013
About this study
The aim of the study is to quantify elementary mechanisms of motivation, with innovative tools adapted to clinical settings, in healthy subjects, and in stroke patients. The secondary aim of the study is to investigate the neural substrates of motivational mechanisms, and to study the impact of lesions in the grey and the white matter, the influence of lesion site.
Read the detailed description
Disorders of motivation, such as apathy, are among the most prevalent symptoms in neuropsychiatric disorders and during chronic diseases. They have a major impact on patients' physical activity and lifestyle, and on their involvement in their own care. They affect a wide range of morbidity outcomes, alter functional recovery in rehabilitation, impair long-term disability, and prevent patients from returning to an active and independent life. Yet, the neural bases of motivational deficits remain largely unknown. Current diagnostic tools are sparse and cannot distinguish between distinct mechanisms responsible for apathetic syndromes. Besides, current treatments remain extremely limited. However, recent advances in the field of neuroeconomics - the science of decision-making - have provided concept and tools to study the neurobiological bases of elementary cognitive processes underlying motivated behaviors. These theories suggest that the brain implements optimization processes that determine our behaviors by minimizing the cost of our actions while maximizing their expected benefits. The adaptation of tools developed for basic research now enables the assessment of these cognitive mechanisms.
Elementary deficits of motivation will be assessed with a phenotyping battery of motivation tests in 20 healthy subjects (up to 10 healthy subjects can be replaced), 20 patients (up to 10 patients can be replaced) with a stroke in the medial prefrontal cortex, and 20 patients (up to 10 patients can be replaced) with a stroke in the insula. This battery will allow us to characterize, at the patient's level, elementary processes such as the encoding of goal values or effort costs, the modulation of cost with fatigue, and the resolution of cost-benefit trade-offs. Symptom-Lesion mapping studies and voxel-based morphometry studies will be performed using whole brain MRI measures of structural integrity.
- Conditions
- Stroke
- Being tested
- Motivation tests
- Keywords
- Motivation, Apathy, Stroke, Reward, Effort
- Medical subject headings
- Stroke, Lethargy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivation testsDiagnostic test
Motivation tests will characterize elementary deficits of motivation
| Study group | Role | What they receive |
|---|---|---|
| medial frontal stroke | Other | 20 patients (up to 10 patients can be replaced) with a stroke in the medial frontal lobe will be included in this arm, and will undergo motivation phenotyping. Receives: Diagnostic Test: Motivation tests |
| lateral frontal stroke | Other | 20 patients (up to 10 patients can be replaced) with a stroke in the lateral frontal lobe will be included in this arm, and will undergo motivation phenotyping. Receives: Diagnostic Test: Motivation tests |
| Healthy participants | Other | 20 healthy participants (up to 10 healthy participants can be replaced) will be included in this arm, and will undergo motivation phenotyping. Receives: Diagnostic Test: Motivation tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reward sensitivity
The reward sensitivity measures the impact of reward values on behavior
Measured: 1 day
Effort sensitivity
The effort sensitivity measures the impact of effort costs on behavior
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2018
- Study start22 Oct 2020
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03741140
- Sponsor's protocol ID
- C17-19
- Other IDs
- 2018-A00511-54 / 1
- Acronym
- MOTI-stroke
- Status last verified
- Nov 2024
- First submitted
- 8 Nov 2018
- Last updated
- 20 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
- Characterizing the Neural Bases of Motivational Disorders After Stroke
- ClinicalTrials.gov ID
- NCT03741140
- Acronym / sponsor ID
- MOTI-stroke / C17-19
- Conditions
- Stroke
- Keywords
- Motivation, Apathy, Stroke, Reward, Effort
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Study start
- 22 Oct 2020 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 14 Nov 2018 (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 aim of the study is to quantify elementary mechanisms of motivation, with innovative tools adapted to clinical settings, in healthy subjects, and in stroke patients. The secondary aim of the study is to investigate the neural substrates of motivational mechanisms, and to study the impact of lesions in the grey and the white matter, the influence of lesion site.
Detailed description
Disorders of motivation, such as apathy, are among the most prevalent symptoms in neuropsychiatric disorders and during chronic diseases. They have a major impact on patients' physical activity and lifestyle, and on their involvement in their own care. They affect a wide range of morbidity outcomes, alter functional recovery in rehabilitation, impair long-term disability, and prevent patients from returning to an active and independent life. Yet, the neural bases of motivational deficits remain largely unknown. Current diagnostic tools are sparse and cannot distinguish between distinct mechanisms responsible for apathetic syndromes. Besides, current treatments remain extremely limited. However, recent advances in the field of neuroeconomics - the science of decision-making - have provided concept and tools to study the neurobiological bases of elementary cognitive processes underlying motivated behaviors. These theories suggest that the brain implements optimization processes that determine our behaviors by minimizing the cost of our actions while maximizing their expected benefits. The adaptation of tools developed for basic research now enables the assessment of these cognitive mechanisms.
Elementary deficits of motivation will be assessed with a phenotyping battery of motivation tests in 20 healthy subjects (up to 10 healthy subjects can be replaced), 20 patients (up to 10 patients can be replaced) with a stroke in the medial prefrontal cortex, and 20 patients (up to 10 patients can be replaced) with a stroke in the insula. This battery will allow us to characterize, at the patient's level, elementary processes such as the encoding of goal values or effort costs, the modulation of cost with fatigue, and the resolution of cost-benefit trade-offs. Symptom-Lesion mapping studies and voxel-based morphometry studies will be performed using whole brain MRI measures of structural integrity.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| medial frontal stroke | Other | Diagnostic Test: Motivation tests20 patients (up to 10 patients can be replaced) with a stroke in the medial frontal lobe will be included in this arm, and will undergo motivation phenotyping. |
| lateral frontal stroke | Other | Diagnostic Test: Motivation tests20 patients (up to 10 patients can be replaced) with a stroke in the lateral frontal lobe will be included in this arm, and will undergo motivation phenotyping. |
| Healthy participants | Other | Diagnostic Test: Motivation tests20 healthy participants (up to 10 healthy participants can be replaced) will be included in this arm, and will undergo motivation phenotyping. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Right-handed
- Age > 18 years old
- Able to squeeze a hand-grip
- Signature of consent form
- Affiliation to an Health Insurance Scheme or beneficiary of such a scheme
Key exclusion criteria (16 listed)
- Under justice protection
- History of neurological or psychiatric diseases
- Evolving disease that could impede volunteer participation during the whole study
- Ongoing psychotropic drug or stopped for less than 3 weeks
- Treatment that could interfere with subject performance
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 |
|---|---|---|
| Motivation testsMotivation tests will characterize elementary deficits of motivation | Diagnostic test | Healthy participants, lateral frontal stroke, medial frontal stroke |
Primary outcome
Reward sensitivity
Time frame: 1 day
The reward sensitivity measures the impact of reward values on behavior
Effort sensitivity
Time frame: 1 day
The effort sensitivity measures the impact of effort costs on behavior
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 20 Feb 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivation tests in people with Stroke, run by Institut National de la Santé Et de la Recherche Médicale, France 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 10 inclusion and 16 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 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. 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?
Reward sensitivity (time frame: 1 day). 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 20 Feb 2025.