At a glance
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Spinal Cord sTimulation thEraPy for Parkinson's Disease Patients With Gait Problems
In Brief
A clinical study evaluating Spinal Cord Stimulation for Parkinson Disease and 2 related conditions. Completed, enrolled 12 participants across 1 site.
Detailed Summary
Gait difficulties are common in Parkinson's disease (PD) and cause significant disability. No treatment is available for these symptoms. Spinal Cord Stimulation (SCS) has been found to improve gait, including freezing of gait, in a small number of PD patients. The mechanism of action is unclear and some patients are nonresponders. With this double-blind placebo-controlled proof of concept and feasibility imaging study, we aim to shed light on the mechanism of action of SCS and collect data to inform development of a scientifically sound clinical trial protocol. We also hope to identify imaging biomarkers at baseline that could be predictive of a favourable or a negative outcome of SCS and improve patient selection. Patients will be assessed with clinical rating scales and gait evaluations at baseline and 6 and 12 months after SCS. They will also receive serial 18F-FDG and (\[18F\]FEOBV) PET scans to assess the effects of SCS on cortical/subcortical activity and brain cholinergic function
Study Details
Timeline
Interventions
Spinal Cord stimulation. Surgery is done in local anaesthesia. A small electrode is placed in the epidural space corresponding approximately at the Th8-Th10 level. An impulsegenerator, connected to the electrode, is placed in the subcutaneus fat in the gluteal region.