- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03741140
Characterizing the Neural Bases of Motivational Disorders After Stroke (MOTI-stroke)
Study Overview
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 and the learning rate of goal values or effort costs, the modulation of value with delay or episodic context, the modulation of cost with fatigue, and the resolution of cost-benefit trade-offs. We will record morbimortality outcomes, such as functional recovery, disability, quality of life and burden for caregivers. Symptom-Lesion mapping studies and voxel-based morphometry studies will be performed using whole brain MRI measures of structural and functional integrity.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Raphael Le Bouc, PD, PhD
- Phone Number: +33 +33 (0) 1 42 16 18 54
- Email: raphael.lebouc@icm-institute.org
Study Locations
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Paris, France, 75013
- Recruiting
- Urgences cérébro-vasculaires hopital Pitié-Salpêtrière
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Contact:
- Raphael Le Bouc
- Phone Number: +33 (0)1 42 16 18 54
- Email: raphael.lebouc@icm-institute.org
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria (healthy volunteers):
- 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
Inclusion Criteria (patients):
- 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
- 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
Exclusion Criteria (healthy volunteers):
- 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 interfer with subject performance
- Chronical use of illicit psychoactive drugs or the day of the exam
- Pregnant, parturient or breastfeeding woman
- Exclusion period of another research
- Contra-indication to MRI scan
- Comprehension difficulties or difficulties to perform the study cognitive tests
Exclusion Criteria (patients):
- 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
- Exclusion period of another research
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: medial frontal stroke
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.
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Motivation tests will characterize elementary deficits of motivation
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Other: lateral frontal stroke
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.
|
Motivation tests will characterize elementary deficits of motivation
|
Other: Healthy participants
20 healthy participants (up to 10 healthy participants can be replaced) will be included in this arm, and will undergo motivation phenotyping.
|
Motivation tests will characterize elementary deficits of motivation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reward sensitivity
Time Frame: 1 day
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The reward sensitivity measures the impact of reward values on behavior
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1 day
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Effort sensitivity
Time Frame: 1 day
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The effort sensitivity measures the impact of effort costs on behavior
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1 day
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- C17-19
- 2018-A00511-54 / 1 (Registry Identifier: IDRCB)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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