Deep Brain Stimulation and Parkinson's Disease

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Parkinson Disease

Intervention / Treatment
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* Device: NIRS EEG HR recording


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients presenting Parkinson disease and treated by STN-DBS. For comparison patients: Patients treated by DBS in other target. Exclusion Criteria: Patients who cannot be treated by DBS

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: parkinson's patient stimulated at STN level<br>15 parkinson's disease patients stimulated at STN level NIRS EEG HR recording | Device: NIRS EEG HR recording<br>* NIRS EEG HR recording<br>|
| Experimental: non STN<br>5 Parkinson's Disease patients who received stimulation in another target that the STN NIRS EEG HR recording | Device: NIRS EEG HR recording<br>* NIRS EEG HR recording<br>|
| Experimental: control<br>20 control patients undergoing DBS for the treatment of OCD NIRS EEG HR recording | Device: NIRS EEG HR recording<br>* NIRS EEG HR recording<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Study of local cortical hemodynamic change (oxy-Hb, deoxy-Hb, and total Hb) | under  on  and  off  stimulation during a motor task. | 1 month, | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Study of local cortical hemodynamic change (oxy-Hb, deoxy-Hb, and total Hb) | under  on  and  off  stimulation during delay discounting task. | 1 month | 
| Study of QUIP score (QUIP scale) |  | 3 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 | between patient with ICD and patient without ICD | 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 local cortical hemodynamic changes (oxy-Hb, deoxy-Hb, and total Hb) with intensity of NonSTN-DBS stimulation | under  on  and  off  stimulation during a motor task and a delay discounting task (in order to obtain a qualitative comparison between GPi-DBS and STN-DBS. | 1 month | 
| Study of delayed discounting task (DDT) score |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Near-InfraRed Spectroscopy (NIRS), Deep brain stimulation of SubThalamic Nucleus (DBS)