Frontal Lobe Epilepsies Clinical Trial
Official title:
Co-operative Behavior and Decision-making in Frontal Lobe Epilepsy
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.
| Status | Completed |
| Enrollment | 30 |
| Est. completion date | September 2015 |
| Est. primary completion date | September 2015 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years to 50 Years |
| Eligibility |
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 |
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science
| Country | Name | City | State |
|---|---|---|---|
| France | Hospices Civils de Lyon | Lyon |
| Lead Sponsor | Collaborator |
|---|---|
| Hospices Civils de Lyon |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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). | 1 day | No |
| Secondary | 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. | 1 day | No |
| Secondary | Neuropsychological profile | analysis of neuropsychological testing of (working) memory, attention, theory-of-mind and executive functions. | 1 day | No |
| Secondary | Pill counts | Pills taken and not-taken during the study period will be counted as a variable of therapy adherence. | 1 day | No |
| Secondary | Scores acquired by questionnaire | Several questionnaires to cover beliefs about therapy adherence will be applied. | 1 day | No |
| Secondary | Scores acquired by questionnaire | questionnaire to cover beliefs about medicines will be applied | 1 day | No |
| Secondary | Scores acquired by questionnaire | questionnaire to cover beliefs about trust towards physicians and medications will be applied | 1 day | No |