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

Primary Purpose

Frontal Lobe Epilepsies

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
functional magnetic resonance imaging exam
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Frontal Lobe Epilepsies focused on measuring cooperative behavior, therapy adherence, fMRI

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Hospices Civils de Lyon

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Patients

Controls

Arm Description

Outcomes

Primary Outcome Measures

Social cooperative behavior as measured by the prisoners' dilemma game
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).

Secondary Outcome Measures

Blood-oxygen-level dependent signal during the Prisoners' dilemma game
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
analysis of neuropsychological testing of (working) memory, attention, theory-of-mind and executive functions.
Pill counts
Pills taken and not-taken during the study period will be counted as a variable of therapy adherence.
Scores acquired by questionnaire
Several questionnaires to cover beliefs about therapy adherence will be applied.
Scores acquired by questionnaire
questionnaire to cover beliefs about medicines will be applied
Scores acquired by questionnaire
questionnaire to cover beliefs about trust towards physicians and medications will be applied

Full Information

First Posted
April 3, 2015
Last Updated
September 21, 2015
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT02441478
Brief Title
Co-operative Behavior and Decision-making in Frontal Lobe Epilepsy
Official Title
Co-operative Behavior and Decision-making in Frontal Lobe Epilepsy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
February 2015 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frontal Lobe Epilepsies
Keywords
cooperative behavior, therapy adherence, fMRI

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients
Arm Type
Experimental
Arm Title
Controls
Arm Type
Active Comparator
Intervention Type
Radiation
Intervention Name(s)
functional magnetic resonance imaging exam
Other Intervention Name(s)
fMRI exam
Primary Outcome Measure Information:
Title
Social cooperative behavior as measured by the prisoners' dilemma game
Description
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).
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Blood-oxygen-level dependent signal during the Prisoners' dilemma game
Description
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.
Time Frame
1 day
Title
Neuropsychological profile
Description
analysis of neuropsychological testing of (working) memory, attention, theory-of-mind and executive functions.
Time Frame
1 day
Title
Pill counts
Description
Pills taken and not-taken during the study period will be counted as a variable of therapy adherence.
Time Frame
1 day
Title
Scores acquired by questionnaire
Description
Several questionnaires to cover beliefs about therapy adherence will be applied.
Time Frame
1 day
Title
Scores acquired by questionnaire
Description
questionnaire to cover beliefs about medicines will be applied
Time Frame
1 day
Title
Scores acquired by questionnaire
Description
questionnaire to cover beliefs about trust towards physicians and medications will be applied
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Hospices Civils de Lyon
City
Lyon
ZIP/Postal Code
69002
Country
France

12. IPD Sharing Statement

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

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