Deep Brain Stimulation and Parkinson's Disease: Analysis of the Modifications of the Cortical Activation During Driving Tasks and During Tasks Involving the Control of the Impulses by Means of the Optical Imaging and of the Technique of Delay Discounting Task

Centre Hospitalier Universitaire, Amiens1 site in 1 country15 target enrollmentSeptember 1, 2014

Overview

Phase: Early Phase 1
Intervention: Not specified
Conditions: Parkinson Disease
Sponsor: Centre Hospitalier Universitaire, Amiens
Enrollment: 15
Locations: 1
Primary Endpoint: Study of local cortical hemodynamic change (oxy-Hb, deoxy-Hb, and total Hb)
Status: Completed
Last Updated: 7 months ago

Background : Deep brain stimulation of SubThalamic Nucleus (STN-DBS) is an effective treatment for a large variety of movement disorders. However, the efficacy of STN-DBS relies on unclear mechanisms.
Purpose: In this study, using optical imaging, the investigators will evaluate the cortical hemodynamic changes induced by STN-DBS of parkinsonian patients during motor task and delay discounting task. the investigators will perform an optical imaging study using Near-InfraRed Spectroscopy (NIRS) in a parkinsonian patient after STN-DBS. The investigators will measure bilateral local cortical hemodynamic changes under "On" and "Off" stimulation conditions and during a motor task (left hand movement) and delay discounting task Relative concentration changes of oxy-Hb, deoxy-Hb, and total Hb will be continuously analyze.
Primary outcome: Study of local cortical hemodynamic change (oxy-Hb, deoxy-Hb, and total Hb) under " on " and " off " stimulation during a motor task.

Registry

clinicaltrials.gov

Start Date

September 1, 2014

End Date

December 1, 2017

Last Updated

7 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Sponsor

Responsible Party

Sponsor

Study of local cortical hemodynamic change (oxy-Hb, deoxy-Hb, and total Hb)

Time Frame: 1 month,

under " on " and " off " stimulation during a motor task.

Study of local cortical hemodynamic change (oxy-Hb, deoxy-Hb, and total Hb)(1 month)
Comparison of local cortical hemodynamic changes (oxy-Hb, deoxy-Hb, and total Hb) with the localisation of the contact use for STN-DBS stimulation(1 month)
Comparison of local cortical hemodynamic changes (oxy-Hb, deoxy-Hb, and total Hb) with intensity of STN-DBS stimulation(1 month)
Study of QUIP score (QUIP scale)(3 month)
Study of delayed discounting task (DDT) score(3 months)
Study of local cortical hemodynamic changes (oxy-Hb, deoxy-Hb, and total Hb) with intensity of NonSTN-DBS stimulation(1 month)