Spinal Cord Stimulation in the Treatment of Parkinson's Disease

Not Applicable

Completed

• Conditions: Parkinson's Disease
• Interventions: Device: spinal cord stimulation (St Jude Medical)

• Registration Number: NCT02381951
• Lead Sponsor: Fondation Ophtalmologique Adolphe de Rothschild

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-03-03
• Study First Submitted QC: 2015-03-05
• Study First Posted: 2015-03-06
• Study Start: 2015-11-24
• Primary Completion: 2017-04-25
• Study Completion: 2017-04-25
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-26
• Last Update Posted: 2017-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Spinal cord stimulation	spinal cord stimulation (St Jude Medical)	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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
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
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 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

Trial Locations

Locations (1)

Fondation Ophtalmologique A. de Rothschild; 🇫🇷 Paris, France