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Spinal Cord Stimulation in the Treatment of Parkinson's Disease (STIMUPARK)

Primary Purpose

Parkinson's Disease

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
spinal cord stimulation (St Jude Medical)
Sponsored by
Fondation Ophtalmologique Adolphe de Rothschild
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fondation Ophtalmologique A. de Rothschild

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Spinal cord stimulation

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
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
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
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

Full Information

First Posted
March 3, 2015
Last Updated
July 26, 2017
Sponsor
Fondation Ophtalmologique Adolphe de Rothschild
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1. Study Identification

Unique Protocol Identification Number
NCT02381951
Brief Title
Spinal Cord Stimulation in the Treatment of Parkinson's Disease
Acronym
STIMUPARK
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
November 24, 2015 (Actual)
Primary Completion Date
April 25, 2017 (Actual)
Study Completion Date
April 25, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondation Ophtalmologique Adolphe de Rothschild

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Spinal cord stimulation
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
spinal cord stimulation (St Jude Medical)
Intervention Description
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
Primary Outcome Measure Information:
Title
improvement in walking capacity
Description
"stand-walk-sit" test : time to complete the test : difference between scores pre-implantation and 2 month post-implantation of stimulator
Time Frame
2 months
Secondary Outcome Measure Information:
Title
freezing episodes : reduction of frequency
Description
"stand-walk-sit" test : total number of freezing episodes during the test : difference between scores pre-implantation and 2 month post-implantation of stimulator
Time Frame
2 months
Title
freezing episodes : reduction of cumulated time
Description
"stand-walk-sit" test : cumulated time of freezing episodes during the test : difference between scores pre-implantation and 2 month post-implantation of stimulator
Time Frame
2 months
Title
improvement in motor score of MultiDimentionalScaling-UPDRS scale
Description
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
Time Frame
2 months
Title
improvement in "freezing of gait" score
Description
percentage of improvement in the "freezing of gate" score, between score pre-implantation and score 2 months post-implantation of stimulator
Time Frame
2 months
Title
improvement in quality of life score
Description
improvement in PDQ 39 quality of life score between pre-implantation visit and 2 months post-implantation of stimulator
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Fondation Ophtalmologique A. de Rothschild
City
Paris
ZIP/Postal Code
75019
Country
France

12. IPD Sharing Statement

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Spinal Cord Stimulation in the Treatment of Parkinson's Disease

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