Parkinson's Disease
Conditions
Brief summary
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.
Interventions
DEVICEspinal cord stimulation (St Jude Medical)
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
Sponsors
Fondation Ophtalmologique Adolphe de Rothschild
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| improvement in walking capacity | 2 months | stand-walk-sit test : time to complete the test : difference between scores pre-implantation and 2 month post-implantation of stimulator |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| freezing episodes : reduction of frequency | 2 months | stand-walk-sit test : total number of freezing episodes during the test : difference between scores pre-implantation and 2 month post-implantation of stimulator |
| freezing episodes : reduction of cumulated time | 2 months | stand-walk-sit test : cumulated time of freezing episodes during the test : difference between scores pre-implantation and 2 month post-implantation of stimulator |
| improvement in motor score of MultiDimentionalScaling-UPDRS scale | 2 months | 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 |
| improvement in freezing of gait score | 2 months | percentage of improvement in the freezing of gate score, between score pre-implantation and score 2 months post-implantation of stimulator |
| improvement in quality of life score | 2 months | improvement in PDQ 39 quality of life score between pre-implantation visit and 2 months post-implantation of stimulator |
Countries
France
Outcome results
None listed