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

Sponsor
Rennes University Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT01537224
Collaborator
(none)
25
1
1
27
0.9

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Measure of the electrophysiological activity of the subthalamic nucleus
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
25 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (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
Study Start Date :
Sep 1, 2011
Anticipated Primary Completion Date :
Sep 1, 2013
Anticipated Study Completion Date :
Dec 1, 2013

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Electrophysiological activity of the subthalamic nucleus [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 CHU Rennes Rennes France 35000

Sponsors and Collaborators

  • Rennes University Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Rennes University Hospital
ClinicalTrials.gov Identifier:
NCT01537224
Other Study ID Numbers:
  • 2011-A00392-39
First Posted:
Feb 23, 2012
Last Update Posted:
Dec 3, 2012
Last Verified:
Nov 1, 2012
Keywords provided by Rennes University Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 3, 2012