StrokeNCT04650425
Causal Evidence for Task Regulation by Anterior Cingulate Cortex
A study testing Cognitive tasks in people with Stroke, 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
- Stroke
- What is being tested?
- Cognitive tasks
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteBelgium
- Study dates
- 29 Apr 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
- Stroke patients: ischemic stroke or intracranial hemorrhage
- Involvement of the frontal lobe
- Lesion is visible on CT and/or MRI and is concordant with clinical presentation during the time of onset
- Patients have to be able to give informed consent themselves
Who cannot join
- Patients with a TIA, i.e. no visible lesion on CT and/or MRI or symptoms less than 24 hours
- Patients with decreased alertness or disorders of consciousness, which makes it impossible for these patients to participate in the experiments
- Active alcohol and/or drug abuse/addiction
- Patients diagnosed with dementia or another neurodegenerative disease, or severe cognitive and/or psychiatric disorders that make it impossible for these patients to participate in the study
- Patients with severe aphasia (as defined by NIHSS score)
- A history of stroke in the frontal lobe is NOT an exclusion criteria (except when the patient has been diagnosed with poststroke frontal dysfunction).
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
University Hospital, department of neurology
Ghent, 9000
Veerle De Herdt, +32(0)9 332 64 81, veerle.deherdt@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 (these values are based on the reward positivity produced by the midbrain dopamine system), 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 goal of this study is to investigate the consequences of ACC damage (and other areas of the frontal lobe) on task regulation within a group of patients who have suffered a stroke in the frontal lobe. Furthermore, the correlation between ACC damage and mood disorders such as depression and apathy is going to be investigated.
Read the detailed description
This is a monocentric prospective interventional clinical trial that will include patients with a stroke in the frontal lobe. Depending on the recruitment manner, participants will undergo one or two sessions of cognitive experiments. The patients will be recruited in two ways, through the Stroke unit and through the outpatient clinic:
- If a patient with an acute stroke in the frontal lobe is admitted to the Stroke unit and is eligible for this study, the patient will be asked if he is willing to participate. After giving informed consent, the first session will take place once the patient has been transferred to a regular neurological ward. After discharge, a second session will take place 6 to 12 months later at the outpatient clinic, preferably combined with a consultation (as part of the standard of care of stroke patients).
- Patients who have had a stroke are followed at the outpatient clinic. Patients who are eligible for this study, will be contacted by the treating stroke supervisor during their consultation (either Prof. Veerle De Herdt or Dr. Dimitri Hemelsoet). If they are willing to participate, the first session will take place either right after the consultation at the outpatient clinic, or - if the patient is not available at that time - a new appointment will be made.
One experimental session consists of the following steps:
- Clinical neurological examination with determining of NIHSS score.
- First cognitive task: the coffee-tea task. During this task, a sequence of 7 images is shown and each image contains three objects. The patient has to choose the right objects to make either coffee or tea. At the end of each sequence they get feedback if they have prepared the beverage correctly or not.
- Short break with positioning of 21 EEG electrodes.
- Second task: the virtual T-maze task with video-EEG recording. During this task, a virtual T-maze is shown and the patient has to choose at each junction whether they go left or right. Depending on which direction they choose, they either get positive or negative feedback. This task is known to elicit the reward positivity. During this task, video-EEG will be recorded and this EEG-data will later on be analysed using ERP analysis.
- If second session, administering of questionnaires: Oxford Cognitive Screen, Becker Depression Inventory, DEX apathy questionnaire.
Furthermore, the investigators are going to use voxel-based lesion symptom mapping to analyze the relationship between tissue damage and behavioural problems and reward positivity amplitude.
It is expected that the coffee-tea task will be more difficult for patients with ACC damage compared to patients with lesions in other areas of the frontal lobe. Also, the amplitude of the ERP signals during the virtual T-maze task will be smaller in patients with ACC damage. Furthermore, the investigators expect to find a connection between ACC damage and mood disorders.
- Conditions
- Stroke
- Being tested
- Cognitive tasks
- Keywords
- Anterior Cingulate Cortex
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive tasksBehavioural
Patients will perform the coffee-tea task and the virtual T-maze task, both in the acute and chronic phase after stroke.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Each participant will undergo one or two sessions, consisting of cognitive tasks, video-EEG recording and administering of questionnaires. Receives: Behavioral: Cognitive tasks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and type of mistakes made during the coffee-tea task
Analysed and compared within sub-groups (classified by using Voxel-based Lesion Symptom Mapping)
Measured: date of inclusion to date of second session, assessed up to 6 to 12 months
Amplitude of reward positivity Event-Related Potential signals
Relationship between reward positivity amplitude and brain damage, investigated by using Voxel-based Lesion Symptom Mapping.
Measured: date of inclusion to date of second session, assessed up to 6 to 12 months
Neurofunctional status
Neurofunctional status as defined by the Oxford Cognitive Score, a scale ranging from 0 to 138 (the higher the score, the better the neurofunctional status)
Measured: 6 to 12 months after stroke
Presence of depression
Presence and severity of depression, evaluated by using the Becker Depression Inventory, a scale that scores from 0 to 63 (the higher the score, the more severe the depression).
Measured: 6 to 12 months after stroke
Presence of apathy
Presence and severity of apathy, evaluated by using the DEX (Dysexecutive) Questionnaire, a scale that scores from 0 to 80 and that is filled in both by the patient and the independent caretaker (e.g. family, friend). The higher the score, the more severe the apathy and dysexecutive problems.
Measured: 6 to 12 months after stroke
Secondary outcomes (1)
Performance of coffee-tea task in subgroup with ACC lesions
Comparing the results of the coffee-tea task performed by the ACC-subgroup to the results of the other subgroups, by using Voxel-based Lesion Symptom Mapping, and therefore assessing the crucial role of ACC on task regulation.
Measured: date of inclusion to date of second session, assessed up to 6 to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2020
- Study start29 Apr 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 StrokeStudies of the same condition, open and under way.
- 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Neurology
- Responsible party
- Sponsor
- Investigators
- Veerle De Herdt, Principal investigator, University Hospital Ghent, Department of Neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04650425
- Sponsor's protocol ID
- BC-08764
- Status last verified
- Dec 2023
- First submitted
- 12 Nov 2020
- Last updated
- 5 Dec 2023
- 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 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Causal Evidence for Task Regulation by Anterior Cingulate Cortex
- ClinicalTrials.gov ID
- NCT04650425
- Acronym / sponsor ID
- BC-08764
- Conditions
- Stroke
- Keywords
- Anterior Cingulate Cortex
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- Neurology
- Study start
- 29 Apr 2021 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 2 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 (these values are based on the reward positivity produced by the midbrain dopamine system), 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 goal of this study is to investigate the consequences of ACC damage (and other areas of the frontal lobe) on task regulation within a group of patients who have suffered a stroke in the frontal lobe. Furthermore, the correlation between ACC damage and mood disorders such as depression and apathy is going to be investigated.
Detailed description
This is a monocentric prospective interventional clinical trial that will include patients with a stroke in the frontal lobe. Depending on the recruitment manner, participants will undergo one or two sessions of cognitive experiments. The patients will be recruited in two ways, through the Stroke unit and through the outpatient clinic:
- If a patient with an acute stroke in the frontal lobe is admitted to the Stroke unit and is eligible for this study, the patient will be asked if he is willing to participate. After giving informed consent, the first session will take place once the patient has been transferred to a regular neurological ward. After discharge, a second session will take place 6 to 12 months later at the outpatient clinic, preferably combined with a consultation (as part of the standard of care of stroke patients).
- Patients who have had a stroke are followed at the outpatient clinic. Patients who are eligible for this study, will be contacted by the treating stroke supervisor during their consultation (either Prof. Veerle De Herdt or Dr. Dimitri Hemelsoet). If they are willing to participate, the first session will take place either right after the consultation at the outpatient clinic, or - if the patient is not available at that time - a new appointment will be made.
One experimental session consists of the following steps:
- Clinical neurological examination with determining of NIHSS score.
- First cognitive task: the coffee-tea task. During this task, a sequence of 7 images is shown and each image contains three objects. The patient has to choose the right objects to make either coffee or tea. At the end of each sequence they get feedback if they have prepared the beverage correctly or not.
- Short break with positioning of 21 EEG electrodes.
- Second task: the virtual T-maze task with video-EEG recording. During this task, a virtual T-maze is shown and the patient has to choose at each junction whether they go left or right. Depending on which direction they choose, they either get positive or negative feedback. This task is known to elicit the reward positivity. During this task, video-EEG will be recorded and this EEG-data will later on be analysed using ERP analysis.
- If second session, administering of questionnaires: Oxford Cognitive Screen, Becker Depression Inventory, DEX apathy questionnaire.
Furthermore, the investigators are going to use voxel-based lesion symptom mapping to analyze the relationship between tissue damage and behavioural problems and reward positivity amplitude.
It is expected that the coffee-tea task will be more difficult for patients with ACC damage compared to patients with lesions in other areas of the frontal lobe. Also, the amplitude of the ERP signals during the virtual T-maze task will be smaller in patients with ACC damage. Furthermore, the investigators expect to find a connection between ACC damage and mood disorders.
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: Cognitive tasksEach participant will undergo one or two sessions, consisting of cognitive tasks, video-EEG recording and administering of questionnaires. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Stroke patients: ischemic stroke or intracranial hemorrhage
- Involvement of the frontal lobe
- Lesion is visible on CT and/or MRI and is concordant with clinical presentation during the time of onset
- Patients have to be able to give informed consent themselves
Key exclusion criteria (6 listed)
- Patients with a TIA, i.e. no visible lesion on CT and/or MRI or symptoms less than 24 hours
- Patients with decreased alertness or disorders of consciousness, which makes it impossible for these patients to participate in the experiments
- Active alcohol and/or drug abuse/addiction
- Patients diagnosed with dementia or another neurodegenerative disease, or severe cognitive and/or psychiatric disorders that make it impossible for these patients to participate in the study
- Patients with severe aphasia (as defined by NIHSS score)
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 |
|---|---|---|
| Cognitive tasksPatients will perform the coffee-tea task and the virtual T-maze task, both in the acute and chronic phase after stroke. | Behavioural | Intervention group |
Primary outcome
Incidence and type of mistakes made during the coffee-tea task
Time frame: date of inclusion to date of second session, assessed up to 6 to 12 months
Analysed and compared within sub-groups (classified by using Voxel-based Lesion Symptom Mapping)
Amplitude of reward positivity Event-Related Potential signals
Time frame: date of inclusion to date of second session, assessed up to 6 to 12 months
Relationship between reward positivity amplitude and brain damage, investigated by using Voxel-based Lesion Symptom Mapping.
Neurofunctional status
Time frame: 6 to 12 months after stroke
Neurofunctional status as defined by the Oxford Cognitive Score, a scale ranging from 0 to 138 (the higher the score, the better the neurofunctional status)
Presence of depression
Time frame: 6 to 12 months after stroke
Presence and severity of depression, evaluated by using the Becker Depression Inventory, a scale that scores from 0 to 63 (the higher the score, the more severe the depression).
Presence of apathy
Time frame: 6 to 12 months after stroke
Presence and severity of apathy, evaluated by using the DEX (Dysexecutive) Questionnaire, a scale that scores from 0 to 80 and that is filled in both by the patient and the independent caretaker (e.g. family, friend). The higher the score, the more severe the apathy and dysexecutive problems.
1 secondary outcome
Performance of coffee-tea task in subgroup with ACC lesions
Time frame: date of inclusion to date of second session, assessed up to 6 to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2023.
- 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.
Veerle De Herdt 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 Cognitive tasks in people with Stroke, 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 4 inclusion and 6 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 Dec 2023. 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 Veerle De Herdt (+3293326481, veerle.deherdt@uzgent.Be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and type of mistakes made during the coffee-tea task (time frame: date of inclusion to date of second session, assessed up to 6 to 12 months). The study lists 5 primary outcomes in all. 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 Dec 2023.