Refractory EpilepsyNCT04684797
Localization of the Reward Positivity to ACC
A study testing Virtual T-maze task in people with Refractory Epilepsy, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
The exact function of the anterior cingulate cortex (ACC) is one of the largest riddles in cognitive neuroscience and a major challenge in mental health research. ACC dysfunction contributes to a broad spectrum of neurological and psychiatric disorders, such as depression, ADHD, Parkinson's disease, OCD and many… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Refractory Epilepsy
- What is being tested?
- Virtual T-maze task
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBelgium
- Study dates
- 4 Mar 2021to 30 Sep 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Patients with refractory epilepsy
- Planned hospitalization at CNM for invasive video-EEG recording with subdural, epidural and/or depth electrodes
- Patients have to be able to give informed consent themselves
- Imaging after placement of electrodes (CT and/or MRI) has to be available
Who cannot join
- Patients known with dementia or severe cognitive and/or psychiatric disorders that makes it impossible for patients to participate in this study
- Active alcohol and/or drug abuse
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Department of Neurology, University Hospital Ghent
Ghent, Oost-Vlaanderen, 9000
Joyce Oerlemans, +3293325607, joyce.oerlemans@ugent.be
About this study
The exact function of the anterior cingulate cortex (ACC) is one of the largest riddles in cognitive neuroscience and a major challenge in mental health research. ACC dysfunction contributes to a broad spectrum of neurological and psychiatric disorders, such as depression, ADHD, Parkinson's disease, OCD and many others, but nobody knows what it actually does. Recently a new theory has been developed about ACC function; the HRL-ACC (Hierarchical Reinforcement Learning Theory of ACC). This theory proposes that the ACC selects and motivates high-level tasks based on the principles of hierarchical reinforcement learning. The ACC associates values with tasks, selects the correct tasks and applies control over other neural networks (such as the dorsolateral prefrontal cortex and basal ganglia), which execute the tasks. The values of these tasks are attributed based on "reward prediction error signals", which are sent from the midbrain dopamine system to the ACC. These signals can be recorded using scalp-EEG as an "event-related brain potential" (ERP), which is called the "reward positivity". Until this day, the exact origin of the reward positivity is not yet known. Studies have delivered strong indirect evidence that the reward positivity is generated in the ACC. However, there is an important lack of direct evidence to support this hypothesis. The goal of this study is to provide direct evidence that the reward positivity is generated in the ACC by letting a group of patients with refractory epilepsy perform the virtual T-maze task (which is known to elicit reward positivity) and simultaneously recording intracranial video-EEG.
Read the detailed description
This is a monocentric prospective interventional clinical trial that will include patients with refractory epilepsy and for whom a hospitalization at the Centre for Neurophysiological Monitoring (CNM) at the University Hospital Ghent is planned for invasive video-EEG recording. This hospitalization is part of a pre-surgical work-up to determine if the patient is eligible for resective surgery. It is important to note that the decision to plan the patient for invasive video-EEG monitoring is made by neurologists and neurosurgeons specialized in refractory epilepsy and is in no way connected to this study.
Every patient that will be admitted to the CNM for invasive video-EEG monitoring has a consultation with Prof. Dr. Alfred Meurs about one month before hospitalization. During this consultation, Prof. Meurs will ask if the patient is willing to participate in this study. If the patient agrees and has given informed consent, the first session of the study will take place directly after the consultation. However, if the patient is not available at that time, a new appointment will be made for the first session. The first session has to take place before admission to the CNM.
The study consists of two experimental sessions. The first session takes place after giving informed consent and before admission to the hospital for invasive video-EEG monitoring. Therefore, this session is completely study-specific and may require and extra visit to the hospital if the patient is not available right after the consultation with Prof. Meurs.
During this session, the patient will perform the virtual T-maze task for 20 minutes while scalp-EEG will be recorded simultaneously. During this task, patients will see a T-maze on a computer screen and have to choose at every junction whether they go left or right. Depending on the direction they choose, they get rewarded or not. This feedback will elicit the reward positivity.
The rationale for this first session is that it is important to know whether or not the patient produces a normal reward positivity measured by scalp EEG, before the intracranial electrodes are placed.
The second session takes place during the admission at the CNM, after the intracranial electrodes are placed. The invasive video-EEG monitoring is part of a pre-surgical work-up and is planned independently from the study. During this session, the patient will once again have to perform the virtual T-maze task while scalp-EEG and intracranial-EEG will simultaneously be recorded.
After the two sessions, the data will be analysed using ERP analysis and the amplitude of the reward positivity will be calculated for every electrode. It is expected that the amplitude of the reward positivity ERP-component will be largest for patients with electrodes in the frontal lobe, located closely to the ACC. This will deliver direct evidence that the reward positivity is in fact generated in the ACC.
- Conditions
- Refractory Epilepsy
- Being tested
- Virtual T-maze task
- Keywords
- Anterior Cingulate Cortex, Reward positivity
- Medical subject headings
- Drug Resistant Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual T-maze taskBehavioural
Patients will have to perform the virtual T-maze task, which is known to elicit reward positivity. During this task, the patients will see a virtual T-maze on a computer screen and have to choose at every junction whether they go right or left. Depending on the direction they choose, they either get positive or negative feedback (reward or no reward). This feedback is chosen completely at random, on a 50% reward/50% no reward basis.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Each participant will undergo two sessions, consisting of performing the virtual T-maze task, scalp-EEG recording and/or intracranial video-EEG recording. Receives: Behavioral: Virtual T-maze task |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distribution of reward positivity amplitude
Calculation of amplitude of reward positivity ERP-component recorded by intracranial electrodes and scalp-distribution of amplitude across all subjects
Measured: Date of inclusion to date of second session (about one month)
Secondary outcomes (1)
Location in brain most likely to represent source of reward positivity
Electrode with highest reward positivity amplitude and corresponding location in brain, analysis across all subjects
Measured: Date of inclusion to date of second session (about one month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2020
- Study start4 Mar 2021
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory EpilepsyStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- University Ghent
- Responsible party
- Sponsor
- Investigators
- Alfred Meurs, MD PhD, Principal investigator, University Hospital Ghent, Department of Neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04684797
- Sponsor's protocol ID
- BC-09088
- Status last verified
- Jan 2024
- First submitted
- 21 Dec 2020
- Last updated
- 5 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Localization of the Reward Positivity to ACC
- ClinicalTrials.gov ID
- NCT04684797
- Acronym / sponsor ID
- BC-09088
- Conditions
- Refractory Epilepsy
- Keywords
- Anterior Cingulate Cortex, Reward positivity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- University Ghent
- Study start
- 4 Mar 2021 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 28 Dec 2020 (actual)
- 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.
The exact function of the anterior cingulate cortex (ACC) is one of the largest riddles in cognitive neuroscience and a major challenge in mental health research. ACC dysfunction contributes to a broad spectrum of neurological and psychiatric disorders, such as depression, ADHD, Parkinson's disease, OCD and many others, but nobody knows what it actually does. Recently a new theory has been developed about ACC function; the HRL-ACC (Hierarchical Reinforcement Learning Theory of ACC). This theory proposes that the ACC selects and motivates high-level tasks based on the principles of hierarchical reinforcement learning. The ACC associates values with tasks, selects the correct tasks and applies control over other neural networks (such as the dorsolateral prefrontal cortex and basal ganglia), which execute the tasks. The values of these tasks are attributed based on "reward prediction error signals", which are sent from the midbrain dopamine system to the ACC. These signals can be recorded using scalp-EEG as an "event-related brain potential" (ERP), which is called the "reward positivity". Until this day, the exact origin of the reward positivity is not yet known. Studies have delivered strong indirect evidence that the reward positivity is generated in the ACC. However, there is an important lack of direct evidence to support this hypothesis. The goal of this study is to provide direct evidence that the reward positivity is generated in the ACC by letting a group of patients with refractory epilepsy perform the virtual T-maze task (which is known to elicit reward positivity) and simultaneously recording intracranial video-EEG.
Detailed description
This is a monocentric prospective interventional clinical trial that will include patients with refractory epilepsy and for whom a hospitalization at the Centre for Neurophysiological Monitoring (CNM) at the University Hospital Ghent is planned for invasive video-EEG recording. This hospitalization is part of a pre-surgical work-up to determine if the patient is eligible for resective surgery. It is important to note that the decision to plan the patient for invasive video-EEG monitoring is made by neurologists and neurosurgeons specialized in refractory epilepsy and is in no way connected to this study.
Every patient that will be admitted to the CNM for invasive video-EEG monitoring has a consultation with Prof. Dr. Alfred Meurs about one month before hospitalization. During this consultation, Prof. Meurs will ask if the patient is willing to participate in this study. If the patient agrees and has given informed consent, the first session of the study will take place directly after the consultation. However, if the patient is not available at that time, a new appointment will be made for the first session. The first session has to take place before admission to the CNM.
The study consists of two experimental sessions. The first session takes place after giving informed consent and before admission to the hospital for invasive video-EEG monitoring. Therefore, this session is completely study-specific and may require and extra visit to the hospital if the patient is not available right after the consultation with Prof. Meurs.
During this session, the patient will perform the virtual T-maze task for 20 minutes while scalp-EEG will be recorded simultaneously. During this task, patients will see a T-maze on a computer screen and have to choose at every junction whether they go left or right. Depending on the direction they choose, they get rewarded or not. This feedback will elicit the reward positivity.
The rationale for this first session is that it is important to know whether or not the patient produces a normal reward positivity measured by scalp EEG, before the intracranial electrodes are placed.
The second session takes place during the admission at the CNM, after the intracranial electrodes are placed. The invasive video-EEG monitoring is part of a pre-surgical work-up and is planned independently from the study. During this session, the patient will once again have to perform the virtual T-maze task while scalp-EEG and intracranial-EEG will simultaneously be recorded.
After the two sessions, the data will be analysed using ERP analysis and the amplitude of the reward positivity will be calculated for every electrode. It is expected that the amplitude of the reward positivity ERP-component will be largest for patients with electrodes in the frontal lobe, located closely to the ACC. This will deliver direct evidence that the reward positivity is in fact generated in the ACC.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Virtual T-maze taskEach participant will undergo two sessions, consisting of performing the virtual T-maze task, scalp-EEG recording and/or intracranial video-EEG recording. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 years or older
- Patients with refractory epilepsy
- Planned hospitalization at CNM for invasive video-EEG recording with subdural, epidural and/or depth electrodes
- Patients have to be able to give informed consent themselves
- Imaging after placement of electrodes (CT and/or MRI) has to be available
Key exclusion criteria (2 listed)
- Patients known with dementia or severe cognitive and/or psychiatric disorders that makes it impossible for patients to participate in this study
- Active alcohol and/or drug abuse
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 |
|---|---|---|
| Virtual T-maze taskPatients will have to perform the virtual T-maze task, which is known to elicit reward positivity. During this task, the patients will see a virtual T-maze on a computer screen and have to choose at every junction whether they go right or left. Depending on the direction they choose, they either get positive or negative feedback (reward or no reward). This feedback is chosen completely at random, on a 50% reward/50% no reward basis. | Behavioural | Intervention group |
Primary outcome
Distribution of reward positivity amplitude
Time frame: Date of inclusion to date of second session (about one month)
Calculation of amplitude of reward positivity ERP-component recorded by intracranial electrodes and scalp-distribution of amplitude across all subjects
1 secondary outcome
Location in brain most likely to represent source of reward positivity
Time frame: Date of inclusion to date of second session (about one month)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
- Individual participant dataSharing planned: Undecided
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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.
Alfred Meurs, MD PhD principal investigator
University Hospital Ghent, Department of Neurology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual T-maze task in people with Refractory Epilepsy, run by University Hospital, Ghent at 1 site in Belgium.
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 5 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 5 Jan 2024. 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 Belgium. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alfred Meurs, MD PhD (+3293326482, alfred.meurs@ugent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distribution of reward positivity amplitude (time frame: Date of inclusion to date of second session (about one month)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jan 2024.