An interventional study of Simon task in Parkinson Disease, sponsored by Assistance Publique Hopitaux De Marseille. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-02-25.
Sponsored by Assistance Publique Hopitaux De Marseille · Not applicable, Interventional, and Basic science
Different results have recently led to question the classical notion according to which the motor and cognitive deficits in Parkinson's disease are tied to a thalamo-cortical inhibition due to the degeneration of the dopaminergic nigro-striatal pathways. Instead, Parkinsons's disease seems accompanied by an increase in motor cortical activity.
A reaction time task, known as the "Simon task" in the literature, allows one to study the influence of irrelevant visual information on decision making. In the most common version of this task (used in the prosed study), the subjects have to choose between a left- and a right-hand keypress according to the color of a visual signal presented either to the left or to the right of a fixation. The to be established association is said "congruent" when the response is ipsilateral to the stimulus and "incongruent" when the response is contralateral to the stimulus. In healthy volunteers, EMG investigations have revealed that in a significant numbers of trials, the contraction of the response agonist is preceded by a infra-liminal contraction of the agonist involved in the non-required response. Such "partial errors" demonstrate that the nervous system is able to detect, abort and correct a part of its errors, thereby revealing the existence of an on-line executive control in simple decision tasks. Behavioral studies performed in Parkinson disease patients, suggest that these patients may experience a deficit in such a control.
The present study aims at testing this hypothesis by assessing the effect of subthalamic stimulation on the patients' performance in a Simon task.
Different results have recently led to question the classical notion according to which the motor and cognitive deficits in Parkinson's disease are tied to a thalamo-cortical inhibition due to the degeneration of the dopaminergic nigro-striatal pathways. Instead, Parkinsons's disease seems accompanied by an increase in motor cortical activity.
A reaction time task, known as the "Simon task" in the literature, allows one to study the influence of irrelevant visual information on decision making. In the most common version of this task (used in the prosed study), the subjects have to choose between a left- and a right-hand keypress according to the color of a visual signal presented either to the left or to the right of a fixation. The to be established association is said "congruent" when the response is ipsilateral to the stimulus and "incongruent" when the response is contralateral to the stimulus. In healthy volunteers, EMG investigations have revealed that in a significant numbers of trials, the contraction of the response agonist is preceded by a infra-liminal contraction of the agonist involved in the non-required response. Such "partial errors" demonstrate that the nervous system is able to detect, abort and correct a part of its errors, thereby revealing the existence of an on-line executive control in simple decision tasks. Behavioral studies performed in Parkinson disease patients, suggest that these patients may experience a deficit in such a control.
Aims
The present study aims at testing this hypothesis by assessing the effect of subthalamic stimulation on the patients' performance in a Simon task.
Methods
Sixteen non-demented Parkinson disease patients treated by deep brain stimulation will be involved in the study. They will perform a Simon task in four conditions: Stimulator ON vs. OFF x Medication ON vs. OFF. The EMG activity of the response agonist will be recorded during task performance. Such recordings will allow the investigator to uncover partial errors. This index together with reaction time and overt errors will be subsequently analysed.
Expected results
Deep brain stimulation (as oral Dopaminergic medication) re-install the patient motor functions and it is thus predicted that both the stimulation and the medication improve the patients executive control by increasing the proportion of partial errors relative to overt errors. Such a result would demonstrate that the nigro-striatal pathways in directly involved in executive control during decision making.
4,484 studies on the registry are indexed under Parkinson Disease; 1,081 are open to participants now.
This study's enrollment of 16 is below the median of 40 across 3,293 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →Assistance Publique Hopitaux De Marseille is the lead sponsor of 686 studies on the registry; 148 are open to participants now.
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Exclusion Criteria:
Day 1 : morning : Medication on ; Stimulation : off afternoon : Medication : on ; Stimulation : on Day 2 : morning : Medication : off ; Stimulation : off afternoon : medication : off ; stimulation : on
Behavioral: Simon task
Day 1 : morning : Medication off ; Stimulation : on afternoon : Medication : off ; Stimulation : off Day 2 : morning : Medication : on ; Stimulation : on afternoon : medication : on ; stimulation : off
Behavioral: Simon task
Day 1 : morning : Medication off ; Stimulation : off afternoon : Medication : off ; Stimulation : on Day 2 : morning : Medication : on ; Stimulation : off afternoon : medication : on ; stimulation : on
Behavioral: Simon task
Day 1 : morning : Medication on ; Stimulation on afternoon : Medication on ; Stimulation off Day 2 : morning : Medication off ; Stimulation on afternoon : Medication off ; Stimulation off
Behavioral: Simon task
Reaction time task
to assess the effect of subthalamic stimulation on the patients' performance in a Simon task.
Time frame: 1 year
This study is completed, as verified in Feb 2014. You cannot join it, but the record below documents what was studied.
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Assistance Publique Hopitaux De Marseille