Parkinson's DiseaseEEGControlNCT03981913
Cognitive Control in Parkinson's Disease
An observational study of Parkinson's Disease, run by Rennes University Hospital at 1 site in France.
Trial summary
Cognitive action control allows resisting to irrelevant information to easily produce desired goal-directed behaviors. This cognitive process is disturbed in patients with Parkinson's disease (PD). However, the neural signature of this impairment has not been clarified yet. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Simon Task with high-density EEG recording
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 6 Jun 2019to 10 Mar 2022
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: PD patients will be recruited from the Neurology unit of the Rennes University Hospital. The study will be proposed to them during their hospitalization, which is independent from this study and occurs as part of their routine care. Most patients are hospitalized in order to conduct pre-surgical evaluations before deep brain stimulation. No changes in treatments or any other type of routine care will be made during this study. HC volunteers will be recruited from the general population using a volunteer database from our lab. HC's travel expenses will be refunded by the hospital
Who may be able to join
- Applicable to all participants (HC and PD patients):
- Age over 18
- Correct or corrected-to-normal vision
- Affiliation to a social security scheme
- Subject having received the information on the protocol and having not manifested his/her opposition to participate.
- Exclusive to patients:
- Idiopathic Parkinson's disease according to the criteria of the United Kingdom Parkinson's Disease Brain Bank Society
Who cannot join
- Applicable to all participants (HC and PD patients):
- Inability to understand the information given about the study or to perform the experimental task;
- Major cognitive impairment (Moca<22) or severe neurocognitive disorder according to the DSM-V (Diagnostic and statistical manual of mental disorders -V);
- Motor difficulties preventing the performance of the task
- Addiction to drugs or alcohol;
- Major person subject to legal protection (safeguard of justice, guardianship), persons deprived of their liberty.
Show all 12Show fewer
- Present or past moderate to severe psychiatric pathology (obsessive-compulsive disorder, bipolar disorder, schizophrenia, etc.);
- Exclusive to patients:
- Present or past neurological pathology other than Parkinson's disease (cerebrovascular accident, head trauma, etc.);
- Treatment by deep brain stimulation.
- Exclusive to healthy participants:
- Present or past neurological pathology
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of the Neuronal Substrates of the Cognitive Action Control in Parkinson's Disease Using High Density EEG
Cognitive action control allows resisting to irrelevant information to easily produce desired goal-directed behaviors. This cognitive process is disturbed in patients with Parkinson's disease (PD). However, the neural signature of this impairment has not been clarified yet. Several studies using electroencéphalography (EEG) showed that conflict situations in healthy participants are inevitably associated with a power increase of neuronal oscillations in the theta frequency band (~4-8Hz) in the medial frontal cortex (MFC). Conflict situations are also associated with theta functional connectivity between the MFC and task-relevant brain areas. The theta power increase and connectivity are respectively interpreted as a marker of the integration of conflicting information and as a candidate for communication between the brain areas involved in implementing cognitive action control. The objective of this project is to test the hypothesis that the deficit of cognitive action control observed in PD comes from a lack of integration of the conflict information and / or communication of this information between the MFC and other task-relevant brain areas. Investigators willl study this cognitive process using a classic conflict task, the Simon task, and by recording brain activity using high density EEG coupled with cortical source connectivity analyses. The results will allow us to evaluate whether theta oscillations can serve as a marker of cognitive control disorders in Parkinson's disease.
Read the detailed description
Alterations in cognitive action control in patients with PD are well described from a behavioral point of view. However, there is currently very little information to directly link these difficulties to functional alterations of brain areas, or of efficient communication within large scale brain networks. Thus, the objective of this project is to specify the neuronal substrates linked to the difficulties in cognitive action control observed in patients with PD. The rational is based on the recent findings on the role of theta (4-8 Hz) neuronal oscillations in cognitive action control. Indeed, converging evidence linked this process to an increase in theta oscillatory power around midfrontal electrodes (FCz, Cz) and to an increase in theta functional connectivity with task-relevant brain areas.
The working hypotheses are based on the hypothesis proposed by Cohen (2014). It proposes that the medial frontal cortex (MFC; around the pre-SMA) would be involved in the integration of conflicting information, observable by studying theta oscillations' power. On the other hand, the phase synchronization of theta oscillations between the MFC and the other task-relevant cortical areas would reflect the degree of recruitment of the entire network participating in the implementation of an efficient cognitive control. Thus, according to this model, a conflict situation would lead to two main measurable electrophysiological reactions in the cortex: i) an increase in the power of theta oscillations around the MFC, ii) an increase in theta phase synchronization between the MFC and the other cortical areas (such as the lateral prefrontal and parietal cortices) involved in implementing cognitive action control. These two electrophysiological effects will be the main judgment criteria of this study.
The hypothesis is that the behavioral difficulties in cognitive action control observed in PD patients stem from a lack of integration of the conflicting information and / or a weaker communication of this information to the areas implementing the cognitive control of the action. The alteration of one or both of these aspects may explain the weaker cognitive action control observed in patients. Moreover, by inspecting the disrupted brain networks, it will be able to make hypotheses explaining the alteration of cognitive control in PD. For example, a weaker functional connectivity between the MFC and the posterior parietal cortex could indicate a lower redirection of attentional resources following the presentation of a conflictual stimulus. Another possibility would be a weaker functional connectivity between the MFC and the inferior prefrontal cortex, which would rather indicate a lack of recruitment of the inhibitory system.
The main hypothesis will be tested by comparing the performance of a group of PD patients to that of a group of healthy participants whose brain activity will be collected during the realization of a Simon task via a high resolution electroencephalography system. The behavioral performances will be compared as well as the source-reconstructed electrophysiological data. Specifically, the power of the theta oscillations within the medial frontal cortex, as well as the phase synchronization between the other cortical areas involved will be compared between the two groups. Brain-behavior relationships will also be investigated in order to try to link PD behavioral impairments to changes in theta oscillatory power/connectivity.
- Conditions
- Parkinson's Disease
- Being tested
- Simon Task with high-density EEG recording
- Keywords
- Cognitive action control, Parkinson's disease, high-density EEG, theta oscillations, medial frontal cortex
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simon Task with high-density EEG recordingBehavioural
The scalp electrical activity will be collected by a 256-electrodes EEG montage (Electrical Geodesics Inc).
During the task, participants will be asked to answer on a right or left button according to the color of a circle (yellow or blue) presented on the left or right side of a screen. Participants will have to ignore the stimulus position and respond only according to its color. This leads to two experimental conditions When the color of the circle and its position indicate the same answer, the situation is congruent and the answer is facilitated. Conversely, when they indicate two opposite responses, a conflict between the two alternative actions appears and must be resolved to provide a correct answer. This situation is said to be incongruent. At each trial, the stimulus is shown to the left or right of a central fixation cross. The participants then have to answer on a right or left button. At each trial, the reaction time and the accuracy of the response will be collected.
| Study group | Role | What they receive |
|---|---|---|
| Healthy control (HC) | Participants without neurological or psychiatric disturbance (n= 30) Receives: Behavioral: Simon Task with high-density EEG recording | |
| Parkinson's disease (PD) | Participants with idiopathic Parkinson's disease but without other neurological or psychiatric disturbance (n= 30) Receives: Behavioral: Simon Task with high-density EEG recording |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in theta source connectivity between PD patients and matched HC in the medial-frontal-prefrontal-parietal regions following conflict situations
The scalp electrical activity will be collected by a 256-electrodes EEG montage (Electrical Geodesics Inc.) placed in the 10-20 and 10-5 systems with a 1000 Hertz sampling rate. The 256 electrodes are arranged on a cap, the electrode placement takes only 5 minutes. Before applying the cap, we will have measured the cranial perimeter of the participant to choose the most suitable cap, three sizes of caps being available. A baseline period will be obtained by recording a 10 minutes resting state activity.
Measured: 45 minutes
Secondary outcomes (1)
Difference in MFC theta source power between PD patients and matched HC following conflict situations
The scalp electrical activity will be collected by a 256-electrodes EEG montage (Electrical Geodesics Inc.) placed in the 10-20 and 10-5 systems with a 1000 Hertz sampling rate. The 256 electrodes are arranged on a cap, the electrode placement takes only 5 minutes. Before applying the cap, we will have measured the cranial perimeter of the participant to choose the most suitable cap, three sizes of caps being available. A baseline period will be obtained by recording a 10 minutes resting state activity.
Measured: 45 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2019
- Study start6 Jun 2019
- Primary completion10 Mar 2022
- Study completion10 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Rennes, Institut des Neurosciences Cliniques de Rennes (INCR), Association des Parkinsoniens d'Ille-et-Vilaine (APIV)
- Responsible party
- Sponsor
- Investigators
- Jean-François Houvenaghel, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03981913
- Sponsor's protocol ID
- 35RC19_8963_EEGControl
- Other IDs
- 2019-A00608-49
- Acronym
- EEGControl
- Status last verified
- May 2023
- First submitted
- 7 Jun 2019
- Last updated
- 3 May 2023
- Results posted
- No
- Data monitoring committee
- No
- 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 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Neuronal Substrates of the Cognitive Action Control in Parkinson's Disease Using High Density EEG
- ClinicalTrials.gov ID
- NCT03981913
- Acronym / sponsor ID
- EEGControl / 35RC19_8963_EEGControl
- Conditions
- Parkinson's Disease
- Keywords
- Cognitive action control, Parkinson's disease, high-density EEG, theta oscillations, medial frontal cortex
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Collaborators
- University of Rennes, Institut des Neurosciences Cliniques de Rennes (INCR), Association des Parkinsoniens d'Ille-et-Vilaine (APIV)
- Study start
- 6 Jun 2019 (actual)
- Primary completion
- 10 Mar 2022 (actual)
- Study completion
- 10 Mar 2022 (actual)
- First posted
- 11 Jun 2019 (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.
Cognitive action control allows resisting to irrelevant information to easily produce desired goal-directed behaviors. This cognitive process is disturbed in patients with Parkinson's disease (PD). However, the neural signature of this impairment has not been clarified yet. Several studies using electroencéphalography (EEG) showed that conflict situations in healthy participants are inevitably associated with a power increase of neuronal oscillations in the theta frequency band (~4-8Hz) in the medial frontal cortex (MFC). Conflict situations are also associated with theta functional connectivity between the MFC and task-relevant brain areas. The theta power increase and connectivity are respectively interpreted as a marker of the integration of conflicting information and as a candidate for communication between the brain areas involved in implementing cognitive action control. The objective of this project is to test the hypothesis that the deficit of cognitive action control observed in PD comes from a lack of integration of the conflict information and / or communication of this information between the MFC and other task-relevant brain areas. Investigators willl study this cognitive process using a classic conflict task, the Simon task, and by recording brain activity using high density EEG coupled with cortical source connectivity analyses. The results will allow us to evaluate whether theta oscillations can serve as a marker of cognitive control disorders in Parkinson's disease.
Detailed description
Alterations in cognitive action control in patients with PD are well described from a behavioral point of view. However, there is currently very little information to directly link these difficulties to functional alterations of brain areas, or of efficient communication within large scale brain networks. Thus, the objective of this project is to specify the neuronal substrates linked to the difficulties in cognitive action control observed in patients with PD. The rational is based on the recent findings on the role of theta (4-8 Hz) neuronal oscillations in cognitive action control. Indeed, converging evidence linked this process to an increase in theta oscillatory power around midfrontal electrodes (FCz, Cz) and to an increase in theta functional connectivity with task-relevant brain areas.
The working hypotheses are based on the hypothesis proposed by Cohen (2014). It proposes that the medial frontal cortex (MFC; around the pre-SMA) would be involved in the integration of conflicting information, observable by studying theta oscillations' power. On the other hand, the phase synchronization of theta oscillations between the MFC and the other task-relevant cortical areas would reflect the degree of recruitment of the entire network participating in the implementation of an efficient cognitive control. Thus, according to this model, a conflict situation would lead to two main measurable electrophysiological reactions in the cortex: i) an increase in the power of theta oscillations around the MFC, ii) an increase in theta phase synchronization between the MFC and the other cortical areas (such as the lateral prefrontal and parietal cortices) involved in implementing cognitive action control. These two electrophysiological effects will be the main judgment criteria of this study.
The hypothesis is that the behavioral difficulties in cognitive action control observed in PD patients stem from a lack of integration of the conflicting information and / or a weaker communication of this information to the areas implementing the cognitive control of the action. The alteration of one or both of these aspects may explain the weaker cognitive action control observed in patients. Moreover, by inspecting the disrupted brain networks, it will be able to make hypotheses explaining the alteration of cognitive control in PD. For example, a weaker functional connectivity between the MFC and the posterior parietal cortex could indicate a lower redirection of attentional resources following the presentation of a conflictual stimulus. Another possibility would be a weaker functional connectivity between the MFC and the inferior prefrontal cortex, which would rather indicate a lack of recruitment of the inhibitory system.
The main hypothesis will be tested by comparing the performance of a group of PD patients to that of a group of healthy participants whose brain activity will be collected during the realization of a Simon task via a high resolution electroencephalography system. The behavioral performances will be compared as well as the source-reconstructed electrophysiological data. Specifically, the power of the theta oscillations within the medial frontal cortex, as well as the phase synchronization between the other cortical areas involved will be compared between the two groups. Brain-behavior relationships will also be investigated in order to try to link PD behavioral impairments to changes in theta oscillatory power/connectivity.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy control (HC) | – | Behavioral: Simon Task with high-density EEG recordingParticipants without neurological or psychiatric disturbance (n= 30) |
| Parkinson's disease (PD) | – | Behavioral: Simon Task with high-density EEG recordingParticipants with idiopathic Parkinson's disease but without other neurological or psychiatric disturbance (n= 30) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- PD patients will be recruited from the Neurology unit of the Rennes University Hospital. The study will be proposed to them during their hospitalization, which is independent from this study and occurs as part of their routine care. Most patients are hospitalized in order to conduct pre-surgical evaluations before deep brain stimulation. No changes in treatments or any other type of routine care will be made during this study. HC volunteers will be recruited from the general population using a volunteer database from our lab. HC's travel expenses will be refunded by the hospital
Key inclusion criteria (7 listed)
- Age over 18
- Correct or corrected-to-normal vision
- Affiliation to a social security scheme
- Subject having received the information on the protocol and having not manifested his/her opposition to participate.
- Idiopathic Parkinson's disease according to the criteria of the United Kingdom Parkinson's Disease Brain Bank Society
Key exclusion criteria (12 listed)
- Inability to understand the information given about the study or to perform the experimental task;
- Major cognitive impairment (Moca<22) or severe neurocognitive disorder according to the DSM-V (Diagnostic and statistical manual of mental disorders -V);
- Motor difficulties preventing the performance of the task
- Addiction to drugs or alcohol;
- Major person subject to legal protection (safeguard of justice, guardianship), persons deprived of their liberty.
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 |
|---|---|---|
| Simon Task with high-density EEG recordingThe scalp electrical activity will be collected by a 256-electrodes EEG montage (Electrical Geodesics Inc). During the task, participants will be asked to answer on a right or left button according to the color of a circle (yellow or blue) presented on the left or right side of a screen. Participants will have to ignore the stimulus position and respond only according to its color. This leads to two experimental conditions When the color of the circle and its position indicate the same answer, the situation is congruent and the answer is facilitated. Conversely, when they indicate two opposite responses, a conflict between the two alternative actions appears and must be resolved to provide a correct answer. This situation is said to be incongruent. At each trial, the stimulus is shown to the left or right of a central fixation cross. The participants then have to answer on a right or left button. At each trial, the reaction time and the accuracy of the response will be collected. | Behavioural | Healthy control (HC), Parkinson's disease (PD) |
Primary outcome
Difference in theta source connectivity between PD patients and matched HC in the medial-frontal-prefrontal-parietal regions following conflict situations
Time frame: 45 minutes
The scalp electrical activity will be collected by a 256-electrodes EEG montage (Electrical Geodesics Inc.) placed in the 10-20 and 10-5 systems with a 1000 Hertz sampling rate. The 256 electrodes are arranged on a cap, the electrode placement takes only 5 minutes. Before applying the cap, we will have measured the cranial perimeter of the participant to choose the most suitable cap, three sizes of caps being available. A baseline period will be obtained by recording a 10 minutes resting state activity.
1 secondary outcome
Difference in MFC theta source power between PD patients and matched HC following conflict situations
Time frame: 45 minutes
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 3 May 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.
Jean-François Houvenaghel principal investigator
Rennes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson's Disease, run by Rennes University Hospital 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 7 inclusion and 12 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 3 May 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 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?
Difference in theta source connectivity between PD patients and matched HC in the medial-frontal-prefrontal-parietal regions following conflict situations (time frame: 45 minutes). 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 3 May 2023.