Spinal Cord sTimulation thEraPy for Parkinson's Disease Patients With Gait Problems (STEP-PD)
Parkinson Disease, Gait Disorders, Neurologic, Fall Injury
About this trial
This is an interventional treatment trial for Parkinson Disease
Eligibility Criteria
Inclusion Criteria:
- Idiopathic PD diagnosed by a movement disorders neurologist
- Presence of gait functional impairment despite optimal medical management
- Able to walk independently without an aid for a minimum of two minutes without rest
- Absence of secondary causes of gait problems
- Able to understand study requirements - able to provide consent
- Above 50 years of age
Exclusion Criteria:
- The presence of another significant neurological/psychiatric disorder or significant disease
- Spinal anatomical abnormalities precluding SCS surgery
- History of stroke or structural lesions on CT that could interfere with image analysis.
- History of chronic pain and severe degenerative spine disease with or without chronic pain
- History of drug addiction or dependency
- Previous DBS surgery for PD
- Pregnancy or breast-feeding.
Sites / Locations
- Aarhus UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
Active
Placebo
All patients will receive surgery with implantation of a SCS device. Patients randomized to the active arm, will receive active stimulation. However, for the purposes of this study, the stimulation paradigm and intensity is designed to be below perceptional thresholds so as to assure appropriate blinding. Blinding will continue for 6 months, followed by a 6 month voluntary open-phase, active extension.
All patients will receive surgery with implantation of a SCS device. Patients randomized to the placebo-arm of the trial will have the device switched of or set to a stimulation intensity of zero. Blinding will continue for 6 months, followed by a 6 month voluntary open-phase, active extension.