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Co-operative Behavior and Decision-making in Frontal Lobe Epilepsy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02441478
Recruitment Status : Completed
First Posted : May 12, 2015
Last Update Posted : September 22, 2015
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Tracking Information
First Submitted Date  ICMJE April 3, 2015
First Posted Date  ICMJE May 12, 2015
Last Update Posted Date September 22, 2015
Study Start Date  ICMJE February 2015
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 7, 2015)
Social cooperative behavior as measured by the prisoners' dilemma game [ Time Frame: 1 day ]
The prisoners' dilemma game (PDG; Trivers, 1971) is a well-studied game derived from economic game theory that has been used extensively to quantify and study cooperative behavior. The two players in the game can choose between two moves, either "co-operate" or "defect". If both players co-operate, they both receive the reward R. If one player defects, while the other one co-operates, then the defector receives the payoff T while the co-operative player receives the payoff S. If both players defect, they both receive the payoff P. (T > R > P > S).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 7, 2015)
  • Blood-oxygen-level dependent signal during the Prisoners' dilemma game [ Time Frame: 1 day ]
    Whole brain analysis of correlation between behavior in the PDG (prisoners' dilemma game) and brain activation as measured by the BOLD (blood-oxygen-level dependent) signal captured through functional MRI as well as group differences between patients and controls.
  • Neuropsychological profile [ Time Frame: 1 day ]
    analysis of neuropsychological testing of (working) memory, attention, theory-of-mind and executive functions.
  • Pill counts [ Time Frame: 1 day ]
    Pills taken and not-taken during the study period will be counted as a variable of therapy adherence.
  • Scores acquired by questionnaire [ Time Frame: 1 day ]
    Several questionnaires to cover beliefs about therapy adherence will be applied.
  • Scores acquired by questionnaire [ Time Frame: 1 day ]
    questionnaire to cover beliefs about medicines will be applied
  • Scores acquired by questionnaire [ Time Frame: 1 day ]
    questionnaire to cover beliefs about trust towards physicians and medications will be applied
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Co-operative Behavior and Decision-making in Frontal Lobe Epilepsy
Official Title  ICMJE Co-operative Behavior and Decision-making in Frontal Lobe Epilepsy
Brief Summary

Epilepsy is a frequent neurological disorder with about a third of patients having seizures despite treatment. At least some of these seizures can be linked to a low compliance and therapy adherence of patients. Compliance is defined as "the extent to which a person's behavior (in terms of taking medication, following diets, or executing life style changes) coincides with medical or health advice". Therapy adherence of patients suffering from epilepsy is low with reported rates between 30 and 50%, although adherence to anticonvulsive drug therapy is critical for effective disease management and low therapy adherence is associated to higher mortality in epilepsy. The reasons for low therapy adherence are still a matter of research. Some known factors influencing compliance in epilepsy are related to its chronic nature, but others seem to lie in a complex interaction between psychiatric comorbidity and an impairment of neural systems underlying behavior. Furthermore, therapy adherence rests a variable difficult to measure, especially in epileptic patients where classical tools such as questionnaires and electronic monitoring devices have been shown to be imprecise. It has been argued that the term 'compliance' should be replaced by 'co-operative behavior' and non-compliance can therefore be interpreted as troubled co-operative behavior. This behavioral approach offers the potential of using tools and methods of the latest developments in behavioral neuroscience. Neuroeconomics, a scientific field on the border of psychology, economics and neuroscience, has used economic game paradigms in order to operationalize cooperative behavior and to identify several brain areas by functional brain imaging that have been linked to social co-operative behavior. The majority of these brain areas are located in the frontal cortex [ventromedial frontal/orbitofrontal cortex, and rostral anterior cingulate cortex. Epilepsies originating in the frontal lobe are subsumed under the term "frontal lobe epilepsy" (FLE) and represent 20-30% of all partial seizures and 25% of all refractory focal epilepsies referred to epilepsy surgery.

The investigator's project plans to study compliance and cooperative behavior of patients suffering from frontal lobe epilepsies through a neuroeconomic approach by (1) comparing the behavior of these patients in the prisoners' dilemma game to the behavior of age-, gender-, and education-matched healthy controls, (2) correlation of game behavior to brain activation measured by functional magnetic resonance imaging in both patients and healthy controls and (3) studying the link between cooperative behavior to compliance captured by pill counts and questionnaires.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Frontal Lobe Epilepsies
Intervention  ICMJE Radiation: functional magnetic resonance imaging exam
Other Name: fMRI exam
Study Arms  ICMJE
  • Experimental: Patients
    Intervention: Radiation: functional magnetic resonance imaging exam
  • Active Comparator: Controls
    Intervention: Radiation: functional magnetic resonance imaging exam
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 21, 2015)
30
Original Estimated Enrollment  ICMJE
 (submitted: May 7, 2015)
40
Actual Study Completion Date  ICMJE September 2015
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria (Patients):

  • Age between 18 and 50
  • Diagnosis of frontal lobe epilepsy
  • Written consent to participate
  • Right-handed
  • Hospital Anxiety and Depression Scale Score under 10
  • Obsessive Compulsive Inventory Score under 40
  • Sufficient language skills
  • Social insurance

Inclusion criteria (controls):

  • Age between 18 and 50
  • Written consent to participate
  • Right-handed
  • Hospital Anxiety and Depression Scale Score under 10
  • Obsessive Compulsive Inventory Score under 40
  • Sufficient language skills
  • Social insurance

Exclusion Criteria (Patients):

  • Seizures types other than epileptic (psychogenic etc.)
  • Mental retardation
  • Epilepsies other than FLE
  • Other known neurological diseases
  • Hospital Anxiety and Depression Scale Score over 10
  • Obsessive Compulsive Inventory Score over 40
  • Pregnancy
  • non-MRI suitable transplants (cardiac pacemaker etc.), claustrophobia, orthopedic diseases that prevent lying in the scanner
  • During exclusion period of other studies
  • No social insurance

Exclusion criteria (controls)

  • History of neurological or psychiatric diseases
  • Hospital Anxiety and Depression Scale Score over 10
  • Obsessive Compulsive Inventory Score over 40
  • Medication other than contraceptives
  • Pregnancy
  • non-MRI suitable transplants (cardiac pacemaker etc.), claustrophobia, orthopedic diseases that prevent lying in the scanner
  • Major perceptive impairments
  • During exclusion period of other studies
  • No social insurance
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02441478
Other Study ID Numbers  ICMJE 69HCL14-0269
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hospices Civils de Lyon
Study Sponsor  ICMJE Hospices Civils de Lyon
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Hospices Civils de Lyon
Verification Date September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP