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CompletedNCT00922909Updated Feb 25, 2014

Executive Control Analysis in Patients Suffering From Parkinson Disease and Treated by Deep Brain Stimulation

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

Phase
Not applicable
Study type
Interventional
Enrollment
16
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Parkinson Disease

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03

In context

Parkinson Disease

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 →

Lead sponsor

Assistance Publique Hopitaux De Marseille is the lead sponsor of 686 studies on the registry; 148 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Parkinson disease
  • Mattis score > 130,MMSE > 24
  • No subthalamic stimulation for 6 months
  • No depressive disease evoluting

Exclusion criteria

Exclusion Criteria:

  • Colorblindness
  • Psychotropic treatment introduced for less than a month
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
16 participants (actual)

Study arms

  • Active comparator
    2

    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

  • Active comparator
    3

    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

  • Active comparator
    4

    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

  • Active comparator
    1

    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

Interventions

  • BehavioralSimon task

    Reaction time task

06

What researchers measure

Primary outcomes

  1. to assess the effect of subthalamic stimulation on the patients' performance in a Simon task.

    Time frame: 1 year

07

Study locations

1 site
  • Assistance Publique-Hopitaux de Marseille
    Marseille, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 25, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00922909
Lead sponsor
Assistance Publique Hopitaux De Marseille
Responsible party
Sponsor
First posted
Jun 17, 2009
Start date
Jun 2009
Primary completion
Jun 2010
Last update
Feb 25, 2014

Study contacts

Jean-Philippe AZULAY
principal investigator · Assistance Publique-Hôpitaux de Marseille

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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