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

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Simon task
Sponsored by
Assistance Publique Hopitaux De Marseille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Parkinson Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Colorblindness
  • Psychotropic treatment introduced for less than a month

Sites / Locations

  • Assistance Publique-Hopitaux de Marseille

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

2

3

4

1

Arm Description

Day 1 : morning : Medication on ; Stimulation : off afternoon : Medication : on ; Stimulation : on Day 2 : morning : Medication : off ; Stimulation : off afternoon : medication : off ; stimulation : on

Day 1 : morning : Medication off ; Stimulation : on afternoon : Medication : off ; Stimulation : off Day 2 : morning : Medication : on ; Stimulation : on afternoon : medication : on ; stimulation : off

Day 1 : morning : Medication off ; Stimulation : off afternoon : Medication : off ; Stimulation : on Day 2 : morning : Medication : on ; Stimulation : off afternoon : medication : on ; stimulation : on

Day 1 : morning : Medication on ; Stimulation on afternoon : Medication on ; Stimulation off Day 2 : morning : Medication off ; Stimulation on afternoon : Medication off ; Stimulation off

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
June 16, 2009
Last Updated
February 24, 2014
Sponsor
Assistance Publique Hopitaux De Marseille
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1. Study Identification

Unique Protocol Identification Number
NCT00922909
Brief Title
Executive Control Analysis in Patients Suffering From Parkinson Disease and Treated by Deep Brain Stimulation
Official Title
Executive Control Analysis in Patients Suffering From Parkinson Disease and Treated by Deep Brain Stimulation (Chronometric and Electromyographic Approach During a Simon Task)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
2
Arm Type
Active Comparator
Arm Description
Day 1 : morning : Medication on ; Stimulation : off afternoon : Medication : on ; Stimulation : on Day 2 : morning : Medication : off ; Stimulation : off afternoon : medication : off ; stimulation : on
Arm Title
3
Arm Type
Active Comparator
Arm Description
Day 1 : morning : Medication off ; Stimulation : on afternoon : Medication : off ; Stimulation : off Day 2 : morning : Medication : on ; Stimulation : on afternoon : medication : on ; stimulation : off
Arm Title
4
Arm Type
Active Comparator
Arm Description
Day 1 : morning : Medication off ; Stimulation : off afternoon : Medication : off ; Stimulation : on Day 2 : morning : Medication : on ; Stimulation : off afternoon : medication : on ; stimulation : on
Arm Title
1
Arm Type
Active Comparator
Arm Description
Day 1 : morning : Medication on ; Stimulation on afternoon : Medication on ; Stimulation off Day 2 : morning : Medication off ; Stimulation on afternoon : Medication off ; Stimulation off
Intervention Type
Behavioral
Intervention Name(s)
Simon task
Intervention Description
Reaction time task
Primary Outcome Measure Information:
Title
to assess the effect of subthalamic stimulation on the patients' performance in a Simon task.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Parkinson disease Mattis score > 130,MMSE > 24 No subthalamic stimulation for 6 months No depressive disease evoluting Exclusion Criteria: Colorblindness Psychotropic treatment introduced for less than a month
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Philippe AZULAY
Organizational Affiliation
Assistance Publique-Hôpitaux de Marseille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assistance Publique-Hopitaux de Marseille
City
Marseille
Country
France

12. IPD Sharing Statement

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

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