Spinal Cord Stimulation in the Treatment of Parkinson's Disease

Parkinson's Disease Clinical Trial

— STIMUPARK  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02381951
• Other study ID #: 2014-A01356-41
• Status: Completed
• Phase: N/A
• First received: March 3, 2015
• Last updated: July 26, 2017
• Start date: November 24, 2015
• Est. completion date: April 25, 2017

Study information

• Verified date: July 2017
• Source: Fondation Ophtalmologique Adolphe de Rothschild
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: April 25, 2017
• Est. primary completion date: April 25, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Device:
• spinal 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

Locations

Country	Name	City	State
France	Fondation Ophtalmologique A. de Rothschild	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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