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Characterizing the Neural Bases of Motivational Disorders After Stroke (StrokeMotiv)

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ClinicalTrials.gov Identifier: NCT03741140
Recruitment Status : Not yet recruiting
First Posted : November 14, 2018
Last Update Posted : February 26, 2019
Sponsor:
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France

Brief 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, and to investigate their predictive value related to morbimortality, disability, and dependence. 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, and the consequences of disconnection in functional networks.

Condition or disease Intervention/treatment Phase
Stroke Diagnostic Test: Motivation tests Not Applicable

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, 20 patients with a recent stroke in the medial prefrontal cortex, and 20 patients 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 monitor morbimortality outcomes, such as the functional recovery in rehabilitation, the delay of professional activity recovery after stroke, 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Characterizing the Neural Bases of Motivational Disorders After Stroke
Estimated Study Start Date : March 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Arm Intervention/treatment
medial frontal stroke
20 patients with a recent stroke (<1 month) in the medial frontal lobe will be included in this arm, and will undergo motivation phenotyping.
Diagnostic Test: Motivation tests
Motivation tests will characterize elementary deficits of motivation

lateral frontal stroke
20 patients with a recent stroke (<1 month) in the lateral frontal lobe will be included in this arm, and will undergo motivation phenotyping.
Diagnostic Test: Motivation tests
Motivation tests will characterize elementary deficits of motivation

Healthy participants
20 patients Healthy participants will be included in this arm, and will undergo motivation phenotyping.
Diagnostic Test: Motivation tests
Motivation tests will characterize elementary deficits of motivation




Primary Outcome Measures :
  1. Reward sensitivity [ Time Frame: 1 day ]
    The reward sensitivity measures the impact of reward values on behavior

  2. Effort sensitivity [ Time Frame: 1 day ]
    The effort sensitivity measures the impact of effort costs on behavior



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age >18
  • Stroke < 1 month

Exclusion Criteria:

  • Other neurological or psychiatric disease
  • use of illicit psychoactive drugs
  • Pregnancy
  • Contra-indication to MRI scan
  • Severe cognitive deficit

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Responsible Party: Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier: NCT03741140     History of Changes
Other Study ID Numbers: C17-19
First Posted: November 14, 2018    Key Record Dates
Last Update Posted: February 26, 2019
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases