- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02381951
Spinal Cord Stimulation in the Treatment of Parkinson's Disease (STIMUPARK)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Paris, France, 75019
- Fondation Ophtalmologique A. De Rothschild
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Spinal cord stimulation
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
improvement in walking capacity
Time Frame: 2 months
|
"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
Time Frame: 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
|
2 months
|
|
freezing episodes : reduction of cumulated time
Time Frame: 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
|
2 months
|
|
improvement in motor score of MultiDimentionalScaling-UPDRS scale
Time Frame: 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
|
2 months
|
|
improvement in "freezing of gait" score
Time Frame: 2 months
|
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
Time Frame: 2 months
|
improvement in PDQ 39 quality of life score between pre-implantation visit and 2 months post-implantation of stimulator
|
2 months
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Synucleinopathies
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurodegenerative Diseases
- Movement Disorders
- Parkinsonian Disorders
- Basal Ganglia Diseases
- Parkinson Disease
- Therapeutics
- Physical Therapy Modalities
- Rehabilitation
- Electric Stimulation Therapy
- Spinal Cord Stimulation
Other Study ID Numbers
- 2014-A01356-41
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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