Spinal Cord Stimulation in the Treatment of Parkinson's Disease
STIMUPARK
1 other identifier
interventional
5
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 3, 2015
CompletedFirst Posted
Study publicly available on registry
March 6, 2015
CompletedStudy Start
First participant enrolled
November 24, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 25, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 25, 2017
CompletedJanuary 6, 2026
July 1, 2017
1.4 years
March 3, 2015
January 2, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
freezing episodes : reduction of frequency
2 months
freezing episodes : reduction of cumulated time
2 months
improvement in motor score of MultiDimentionalScaling-UPDRS scale
2 months
improvement in "freezing of gait" score
2 months
improvement in quality of life score
2 months
Study Arms (1)
Spinal cord stimulation
EXPERIMENTALInterventions
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
Eligibility Criteria
You may qualify if:
- Idiopathic Parkinson's disease since more than 5 years
- Walking disorder with freezing episodes, insufficiently alleviated by oral dopaminergic therapy and/or physiotherapy
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fondation Ophtalmologique A. de Rothschild
Paris, 75019, France
Related Publications (1)
Hubsch C, D'Hardemare V, Ben Maacha M, Ziegler M, Patte-Karsenti N, Thiebaut JB, Gout O, Brandel JP. Tonic spinal cord stimulation as therapeutic option in Parkinson disease with axial symptoms: Effects on walking and quality of life. Parkinsonism Relat Disord. 2019 Jun;63:235-237. doi: 10.1016/j.parkreldis.2019.02.044. Epub 2019 Mar 2.
PMID: 30852148RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 3, 2015
First Posted
March 6, 2015
Study Start
November 24, 2015
Primary Completion
April 25, 2017
Study Completion
April 25, 2017
Last Updated
January 6, 2026
Record last verified: 2017-07