Spinal Cord Stimulation in the Treatment of Parkinson's Disease

Study Overview
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Brief Summary
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Parkinson's disease affects between 100'000 and 150'000 people in France. Drug therapy (L-Dopa and other drugs) is effective to improve motor symptoms but after an initial 'honeymoon period' lasting a few years, motor symptoms reoccur in most patients, impairing gait and walking. Spinal cord stimulation is currently an important therapeutic option in the treatment of neuropathic pain. Experimental and limited clinical data suggest that this technique might also be used to alleviate motor symptoms and improve walking in Parkinsons patients. This exploratory study aims at measuring the benefits of spinal cord stimulation on the walking capacity of a small number of Parkinsons patients who are not adequately improved by drug therapy alone.

Conditions
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Parkinson's Disease

Intervention / Treatment
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* Device: spinal cord stimulation (St Jude Medical)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Idiopathic Parkinson's disease since more than 5 years Walking disorder with freezing episodes, insufficiently alleviated by oral dopaminergic therapy and/or physiotherapy Exclusion Criteria: Atypical Parkinson-like syndrome (e.g. progressive supranuclear palsy) Cognitive impairment (MMSE<24) Psychiatric disease Contraindication of surgery Neuropathic pain in the lower limb or lumbar region

Ages Eligible for Study
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Minimum Age: 40 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: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Spinal cord stimulation<br> | Device: spinal cord stimulation (St Jude Medical)<br>* implantation of a spinal cord neurostimulation system : St Jude Medical Octrode 3183 (R) peridural lead connected to a St Jude Medical EonC (R) primary cell IPG<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| improvement in walking capacity | stand-walk-sit test : time to complete the test : difference between scores pre-implantation and 2 month post-implantation of stimulator | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| freezing episodes : reduction of frequency | stand-walk-sit test : total number of freezing episodes during the test : difference between scores pre-implantation and 2 month post-implantation of stimulator | 2 months | 
| freezing episodes : reduction of cumulated time | stand-walk-sit test : cumulated time of freezing episodes during the test : difference between scores pre-implantation and 2 month post-implantation of stimulator | 2 months | 
| improvement in motor score of MultiDimentionalScaling-UPDRS scale | percentage of improvement in the motor score (part III of scale) of MultiDimentionalScaling-UPDRS scale, between score pre-implantation and score 2 months post-implantation of stimulator | 2 months | 
| improvement in freezing of gait score | percentage of improvement in the freezing of gate score, between score pre-implantation and score 2 months post-implantation of stimulator | 2 months | 
| improvement in quality of life score | improvement in PDQ 39 quality of life score between pre-implantation visit and 2 months post-implantation of stimulator | 2 months |