Exploring the Effects of Spinal Cord Stimulation in Parkinson's Disease.
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Parkinson Disease
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: A total of 10 patients with a diagnosis of Parkinson's disease and treatment refractory freezing of gait will be recruited in this study.Masking: None (Open Label)Primary Purpose: Device Feasibility
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
Freezing of gait (FOG) is a devastating motor phenomenon which may occur in patients with Parkinson's Disease (PD) and other neurodegenerative disorders. It is characterized by episodes during which patients cannot generate effective forward stepping movements in the absence of motor deficits. FOG l...
Freezing of gait (FOG) is a devastating motor phenomenon which may occur in patients with Parkinson's Disease (PD) and other neurodegenerative disorders. It is characterized by episodes during which patients cannot generate effective forward stepping movements in the absence of motor deficits. FOG leads to reduced mobility, loss of independence, social embarrassment, and caregiver stress. While most motor features of PD respond robustly to dopaminergic agents and deep brain stimulation (DBS), there are currently no effective treatments for FOG. Indirect evidence from case reports of PD patients undergoing spinal cord stimulation (SCS) for neuropathic pain, has consistently described a positive effect of SCS on FOG. In addition, two recent reports demonstrated that thoracic SCS improved locomotion and FOG in patients with advanced PD. The promising role of SCS for the treatment of FOG in PD has encouraged us to assemble a multi-disciplinary team for the systematic investigation of the motor effects of SCS on FOG, locomotion and other parkinsonian features. The current study integrates minimally invasive SCS and the use of robotic technology to determine objective gait parameters. The investigators propose a pilot study for the implantation of SCS to the spinal cord on PD patients with treatment-refractory FOG, including a longitudinal assessment of motor outcomes.
Tracking Information
- NCT #
- NCT03526991
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Nora Vanegas, MD Baylor College of Medicine