Frontal Lobe EpilepsiesNCT02441478
Co-operative Behavior and Decision-making in Frontal Lobe Epilepsy
A study testing functional magnetic resonance imaging exam in people with Frontal Lobe Epilepsies, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Frontal Lobe Epilepsies
- What is being tested?
- functional magnetic resonance imaging exam
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2015to Sep 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- Sufficient language skills
- Social insurance
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Frontal Lobe Epilepsies
- Being tested
- functional magnetic resonance imaging exam
- Keywords
- cooperative behavior, therapy adherence, fMRI
- Medical subject headings
- Epilepsy, Frontal Lobe, Cooperative Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
functional magnetic resonance imaging examRadiation
Also called fMRI exam
| Study group | Role | What they receive |
|---|---|---|
| Patients | Experimental | Not described Receives: Radiation: functional magnetic resonance imaging exam |
| Controls | Active comparator | Not described Receives: Radiation: functional magnetic resonance imaging exam |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 1 day
Secondary outcomes (6)
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.
Measured: 1 day
Neuropsychological profile
analysis of neuropsychological testing of (working) memory, attention, theory-of-mind and executive functions.
Measured: 1 day
Pill counts
Pills taken and not-taken during the study period will be counted as a variable of therapy adherence.
Measured: 1 day
Scores acquired by questionnaire
Several questionnaires to cover beliefs about therapy adherence will be applied.
Measured: 1 day
Scores acquired by questionnaire
questionnaire to cover beliefs about medicines will be applied
Measured: 1 day
Scores acquired by questionnaire
questionnaire to cover beliefs about trust towards physicians and medications will be applied
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2015 (estimated)
- Study startFeb 2015
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Frontal Lobe EpilepsiesStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02441478
- Sponsor's protocol ID
- 69HCL14-0269
- Status last verified
- Aug 2025
- First submitted
- 3 Apr 2015
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Javor A, Ciumas C, Ibarrola D, Ryvlin P, Rheims S. Social cognition, behaviour and therapy adherence in frontal lobe epilepsy: a study combining neuroeconomic and neuropsychological methods. R Soc Open Sci. 2019 Aug 28;6(8):180850. doi: 10.1098/rsos.180850. eCollection 2019 Aug.
PubMed 31598216
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Co-operative Behavior and Decision-making in Frontal Lobe Epilepsy
- ClinicalTrials.gov ID
- NCT02441478
- Acronym / sponsor ID
- 69HCL14-0269
- Conditions
- Frontal Lobe Epilepsies
- Keywords
- cooperative behavior, therapy adherence, fMRI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 12 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | Experimental | Radiation: functional magnetic resonance imaging exam |
| Controls | Active comparator | Radiation: functional magnetic resonance imaging exam |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- Age between 18 and 50
- Diagnosis of frontal lobe epilepsy
- Written consent to participate
- Right-handed
- Hospital Anxiety and Depression Scale Score under 10
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| functional magnetic resonance imaging examAlso: fMRI exam | Radiation | Controls, Patients |
Primary outcome
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).
6 secondary outcomes
Blood-oxygen-level dependent signal during the Prisoners' dilemma game
Time frame: 1 day
Neuropsychological profile
Time frame: 1 day
Pill counts
Time frame: 1 day
Scores acquired by questionnaire
Time frame: 1 day
Scores acquired by questionnaire
Time frame: 1 day
Scores acquired by questionnaire
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
- Results publication: PubMed 31598216Javor A, Ciumas C, Ibarrola D, Ryvlin P, Rheims S. Social cognition, behaviour and therapy adherence in frontal lobe epilepsy: a study combining neuroeconomic and neuropsychological methods. R Soc Open Sci. 2019 Aug 28;6(8):180850. doi: 10.1098/rsos.180850. eCollection 2019 Aug.
Related trials for Frontal Lobe Epilepsies
RecruitingObservational study
Surgery as a Treatment for Medically Intractable Epilepsy
Epilepsy, Epilepsy, Temporal Lobe
RecruitingObservational study
Changes in Attentional Control After a Focal Seizure.
Temporal Lobe Epilepsy, Frontal Lobe Epilepsy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing functional magnetic resonance imaging exam in people with Frontal Lobe Epilepsies, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Social cooperative behavior as measured by the prisoners' dilemma game (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02441478, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2025.