Effects of Spinal Cord Stimulation on Gait in Patients With Parkinson´s Disease
Parkinson Disease, Gait Disorders, Neurologic
About this trial
This is an interventional treatment trial for Parkinson Disease focused on measuring gait, Parkinson´s disease, Spinal Cord stimulation
Eligibility Criteria
Inclusion Criteria:
- Diagnosed Parkinson´s Disease with Hoehn Yahr scale between 2,5 and 4,0
- Main complaint of balance or freezing of gait
- Score of 2 or more on subitem 3.11 of the MDS UPDRS scale concerning Freezing of Gait severity.
- Capable of informed consent
Exclusion Criteria:
- Frequent lower limb, lower back or hip pain scoring 3 or more on visual analog scale
- Uncontrolled or serious comorbidities such as uncontrolled diabetes mellitus, renal disease, anticoagulation, immunosuppression or other medical conditions that present a contraindication for SCS surgery
- Psychosis, uncontrolled depression (BDI >14) or anxiety disorder (BAI >14)
Sites / Locations
- Hospital das Clínicas da Faculdade de Medicina da USP
Arms of the Study
Arm 1
Arm 2
Experimental
Sham Comparator
Active stimulation
Sham stimulation
During active stimulation phase, patients will receive through the spinal cord stimulator active tonic stimulation with amplitude set to 90% of paresthesia inducing threshold, therefore allowing blinding. Patients will be evaluated after a two week wash out period with no stimulation and after two weeks of continuous active stimulation.
During sham stimulation phase, patients will receive through the spinal cord stimulator a zero amplitude stimulation, therefore having no electrical current passing through epidural leads but with the program status still displayed as "on" if checked with patient's personal controller. Patients will be evaluated after a two week wash out period with no stimulation and after two weeks of continuous sham stimulation.