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

Parkinson Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01537224
• Other study ID #: 2011-A00392-39
• Status: Recruiting
• Phase: N/A
• First received: February 10, 2012
• Last updated: November 30, 2012
• Start date: September 2011
• Est. completion date: December 2013

Study information

• Verified date: November 2012
• Source: Rennes University Hospital
• Contact: Paul Sauleau, MD, PhD
• Email: paul.sauleau[@]chu-rennes.fr
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: December 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Parkinson
• Parkinson Disease

Intervention

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.

Locations

Country	Name	City	State
France	CHU Rennes	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	5 days	No