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Electrophysiological Activity of the Subthalamic Nucleus During the Processing of Emotional and Motivational Information (EMOPHYSIO)

Primary Purpose

Parkinson

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Measure of the electrophysiological activity of the subthalamic nucleus
Sponsored by
Rennes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Parkinson focused on measuring Electrophysiology, Subthalamic nucleus, Parkinson

Eligibility Criteria

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

Inclusion Criteria:

  • Patient with Parkinson's disease selected for deep brain stimulation (DBS) of the subthalamic nucleus (STN) in accordance with the criteria established by Welter and colleagues (Welter et al., 2002);
  • Aged 18 years or above;
  • Written informed consent from the patient.

Exclusion Criteria:

  • Patient under a legal incapacity or with limited legal capacity;
  • Patient who has perioperative complications or postoperative confusion;
  • Patient displaying cognitive disturbances involving the early stages of speech processing (on the basis of an audiogram systematically conducted prior to surgery) ;
  • Patient displaying cognitive disturbances involving the early stages of face processing (on the basis of the Benton Facial Recognition Test (Benton, Hamsher, Varney, & Spreen, 1983) systematically administered prior to surgery);
  • Patient incapable of understanding the information given about the study, performing the tasks or providing informed consent.

Sites / Locations

  • CHU RennesRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

neurostimulation

Arm Description

Outcomes

Primary Outcome Measures

Electrophysiological activity of the subthalamic nucleus
Electrophysiological activity of the subthalamic nucleus will be measured during the perception of auditory and visual stimuli with emotional or motivational connotations in patients with Parkinson disease who have just undergone implatation of a deep brain stimulator in the subthalamic nucleus

Secondary Outcome Measures

Full Information

First Posted
February 10, 2012
Last Updated
November 30, 2012
Sponsor
Rennes University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01537224
Brief Title
Electrophysiological Activity of the Subthalamic Nucleus During the Processing of Emotional and Motivational Information
Acronym
EMOPHYSIO
Official Title
Study of the Electrophysiological Activity of the Subthalamic Nucleus During the Processing of Emotional and Motivational Information in Patients With Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Unknown status
Study Start Date
September 2011 (undefined)
Primary Completion Date
September 2013 (Anticipated)
Study Completion Date
December 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rennes University Hospital

4. Oversight

5. Study Description

Brief Summary
The role of the basal ganglia in the processing of information with emotional or motivational content has been demonstrated by several lesion and functional imaging studies in humans and animals. Deep brain stimulation surgery provides an opportunity to study these structures in humans in electrophysiological terms. The aim of this study is to investigate modifications in the electrophysiological activity of the subthalamic nucleus (STN) during the perception of auditory and visual stimuli with emotional or motivational connotations in patients with Parkinson's disease who have just undergone implantation of a deep brain stimulator in the STN.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson
Keywords
Electrophysiology, Subthalamic nucleus, Parkinson

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
neurostimulation
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Measure of the electrophysiological activity of the subthalamic nucleus
Intervention Description
Local field recording of the subthalamic nucleus by mean of externalized electrodes in the immediate postoperative periode.
Primary Outcome Measure Information:
Title
Electrophysiological activity of the subthalamic nucleus
Description
Electrophysiological activity of the subthalamic nucleus will be measured during the perception of auditory and visual stimuli with emotional or motivational connotations in patients with Parkinson disease who have just undergone implatation of a deep brain stimulator in the subthalamic nucleus
Time Frame
5 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient with Parkinson's disease selected for deep brain stimulation (DBS) of the subthalamic nucleus (STN) in accordance with the criteria established by Welter and colleagues (Welter et al., 2002); Aged 18 years or above; Written informed consent from the patient. Exclusion Criteria: Patient under a legal incapacity or with limited legal capacity; Patient who has perioperative complications or postoperative confusion; Patient displaying cognitive disturbances involving the early stages of speech processing (on the basis of an audiogram systematically conducted prior to surgery) ; Patient displaying cognitive disturbances involving the early stages of face processing (on the basis of the Benton Facial Recognition Test (Benton, Hamsher, Varney, & Spreen, 1983) systematically administered prior to surgery); Patient incapable of understanding the information given about the study, performing the tasks or providing informed consent.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Paul Sauleau, MD, PhD
Email
paul.sauleau@chu-rennes.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc Verin, MD, PhD
Organizational Affiliation
Rennes University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Rennes
City
Rennes
ZIP/Postal Code
35000
Country
France
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

Electrophysiological Activity of the Subthalamic Nucleus During the Processing of Emotional and Motivational Information

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