NCT01537224

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 12, 2011

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 10, 2012

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 23, 2012

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 26, 2015

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

June 15, 2026

Status Verified

June 1, 2026

Enrollment Period

4.2 years

First QC Date

February 10, 2012

Last Update Submit

June 12, 2026

Conditions

Keywords

ElectrophysiologySubthalamic nucleusParkinson

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

neurostimulation

OTHER
Other: Measure of the electrophysiological activity of the subthalamic nucleus

Interventions

Local field recording of the subthalamic nucleus by mean of externalized electrodes in the immediate postoperative periode.

neurostimulation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Rennes

Rennes, 35000, France

Location

Study Officials

  • Marc Verin, MD, PhD

    Rennes University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2012

First Posted

February 23, 2012

Study Start

September 12, 2011

Primary Completion

November 26, 2015

Study Completion

October 1, 2016

Last Updated

June 15, 2026

Record last verified: 2026-06

Locations