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NCT Number: NCT02381951

Spinal Cord Stimulation in the Treatment of Parkinson's Disease

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.

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fondation Ophtalmologique A. de Rothschild

Paris, 75019, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

spinal cord stimulation (St Jude Medical)

Device

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 outcomes

  1. 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

Secondary outcomes

  1. 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. 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

  3. 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

  4. 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

  5. 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

Sponsors and collaborators

Lead sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Network

Registry information

Acronym: STIMUPARK

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Mar 6, 2015
Registry last updated
Jan 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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