Cognitive Control in Parkinson's Disease (NCT03981913) | Clinical Trial Compass
CompletedNot Applicable
Cognitive Control in Parkinson's Disease
France60 participantsStarted 2019-06-06
Plain-language 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. 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
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
Exclusion Criteria:
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.
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Difference in theta source connectivity between PD patients and matched HC in the medial-frontal-prefrontal-parietal regions following conflict situations