NCT03981913|Completed
Cognitive Control in Parkinson's Disease
EEGControl
Study of the Neuronal Substrates of the Cognitive Action Control in Parkinson's Disease Using High Density EEG
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EEGControl
Study of the Neuronal Substrates of the Cognitive Action Control in Parkinson's Disease Using High Density EEG
Sponsor study identifier
Secondary identifiers
OTHER · ANSM ( french national agency for drugs)
observational
60
1 country
1
Study Start
June 6, 2019
Actual (reported)Primary Completion
March 10, 2022
Actual (reported)Study Completion
March 10, 2022
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 10, 2022
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 6, 2019
Actual (reported)June 7, 2019
Actual (reported)June 11, 2019
Actual (reported)March 10, 2022
Actual (reported)March 10, 2022
Actual (reported)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.
45 minutes
Difference in MFC theta source power between PD patients and matched HC following conflict situations
45 minutes
Participants without neurological or psychiatric disturbance (n= 30)
Participants with idiopathic Parkinson's disease but without other neurological or psychiatric disturbance (n= 30)
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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
Rennes University Hospital
Rennes, 35000, France
Jean-François Houvenaghel
Rennes University Hospital
60 participants (actual enrollment reported by the registry).
First Submitted
June 7, 2019
First Posted
June 11, 2019
Study Start
June 6, 2019
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
March 10, 2022
Actual (reported)Study Completion
March 10, 2022
Actual (reported)Last Updated
May 3, 2023
Record last verified: 2023-05
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Source: ClinicalTrials.gov.
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