Exploring the Effects of Spinal Cord Stimulation in Parkinson's Disease (H-49023)
We are seeking participants for this research study who Parkinson's Disease and have problems moving their feet in a forward direction (called gait freezing). Participation is voluntary and you can withdraw your participation at anytime. As an alternative to participating in this research study you can choose not to participate.
This research study will use a spinal cord stimulator that is FDA approved to treat pain to see how it affects your movement. Spinal cord stimulation may decrease the episodes where you can't move your feet in a forward direction and may also improve your overall movement and walking characteristics. However, there is a possibility of the spinal cord stimulator having no affect on your problems with moving your feet in a forward direction or your overall movement. It is possible that you could have no direct benefit by participating in this research study.
The Principal Investigator has FDA approval under an Investigational Device Exemption to use the spinal cord stimulator in this research study. The spinal cord stimulator will be surgically implanted, or surgically placed, on your spine permanently, in most cases. The most common side effects with spinal cord stimulation implantation are device failure and need to replace the stimulator (1 out of 10 patients), need for repositioning the stimulator (2-3 out of 10 patients), pain in the area of the surgery (less than 1 out of 10 patients) and infection on top of your skin (less than 1 out of 10 patients). Rare risks that occur in less than 1 out of 100 patients are increased bleeding, infection under your skin, spinal cord injury and leaking of the fluid from your brain/spine. To minimize these risks you will not be enrolled in this research study if you have pre-existing conditions that may increase your risks.
You will also be asked to stop your Parkinson's Disease medications for short periods of time to further assess the effectiveness of the spinal cord stimulator. You will then have research visits where you complete evaluations, movement assessments, questionnaires and a fall diary. The movement assessments can be comparable to walking 1/2 a city block. You will be randomized to 1 of 3 treatment groups for 8 weeks. You will then be removed from all treatment for about a week, then you will be randomized a second time to 1 of 2 treatment groups for another 8 weeks. You will not know which treatment group you are randomized to.
After 18 weeks of research participation you will have the option to continue in the research study for another 8 months in an open-label extension. During the open-label extension, you will know which treatment group you are assigned to. You will be consented to a new research consent form if you wish to continue participation in the open-label extension research study.