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

This study is currently recruiting participants.
Verified November 2012 by Rennes University Hospital
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital
ClinicalTrials.gov Identifier:
NCT01537224
First received: February 10, 2012
Last updated: November 30, 2012
Last verified: November 2012
History of Changes
  Purpose

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.


Condition Intervention
Parkinson
 Other: Measure of the electrophysiological activity of the subthalamic nucleus

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Rennes University Hospital:

Primary Outcome Measures:
  • Electrophysiological activity of the subthalamic nucleus [ Time Frame: 5 days ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 25
Study Start Date: September 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01537224

Contacts
Contact: Paul Sauleau, MD, PhD paul.sauleau@chu-rennes.fr

Locations
France
CHU Rennes Recruiting
Rennes, France, 35000
Sponsors and Collaborators
Rennes University Hospital
Investigators
Principal Investigator: Marc Verin, MD, PhD Rennes University Hospital
  More Information

No publications provided

Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT01537224     History of Changes
Other Study ID Numbers: 2011-A00392-39
Study First Received: February 10, 2012
Last Updated: November 30, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Rennes University Hospital:
Electrophysiology
Subthalamic nucleus
Parkinson

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on May 21, 2013