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

November 30, 2012 updated by: Rennes University Hospital

Study of the Electrophysiological Activity of the Subthalamic Nucleus During the Processing of Emotional and Motivational Information in Patients With Parkinson's Disease

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Rennes, France, 35000
        • Recruiting
        • CHU Rennes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: neurostimulation
Other: Measure of the electrophysiological activity of the subthalamic nucleus
Local field recording of the subthalamic nucleus by mean of externalized electrodes in the immediate postoperative periode.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Electrophysiological activity of the subthalamic nucleus
Time Frame: 5 days
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
5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rennes University Hospital

Investigators

  • Principal Investigator: Marc Verin, MD, PhD, Rennes University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Anticipated)

September 1, 2013

Study Completion (Anticipated)

December 1, 2013

Study Registration Dates

First Submitted

February 10, 2012

First Submitted That Met QC Criteria

February 22, 2012

First Posted (Estimate)

February 23, 2012

Study Record Updates

Last Update Posted (Estimate)

December 3, 2012

Last Update Submitted That Met QC Criteria

November 30, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011-A00392-39

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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