Effects of spinal cord stimulation on freezing of gait in Parkinson's disease
Exploring the Effects of Spinal Cord Stimulation in Parkinson's Disease.
This study is testing if spinal cord stimulation can help people with Parkinson's disease who struggle with freezing of gait when other treatments haven't worked.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Baylor College of Medicine Academic / other |
| Locations | 2 sites (New York, New York and 1 other locations) |
| Trial ID | NCT03526991 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of spinal cord stimulation (SCS) for managing freezing of gait (FOG) in patients with Parkinson's disease who do not respond to conventional treatments. It aims to assess the impact of SCS on FOG episodes and overall locomotion through a pilot study involving the implantation of SCS. The study will utilize robotic technology to objectively measure gait parameters and will include a longitudinal assessment of motor outcomes. The hypothesis is that SCS will significantly reduce FOG episodes in these patients.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old with idiopathic Parkinson's disease experiencing levodopa-refractory freezing of gait.
Not a fit: Patients with co-morbid psychiatric illnesses that interfere with the study's assessments may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a new treatment option for Parkinson's disease patients suffering from debilitating freezing of gait.
How similar studies have performed: Previous studies have shown promising results with spinal cord stimulation in improving freezing of gait in Parkinson's disease, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Males and females between older than 18 years of age. * Able to provide informed consent * Diagnosed with idiopathic PD (meeting at least two of the three United Kingdom (UK) Brain Bank criteria for PD, specifically bradykinesia plus resting tremor or rigidity) whose major complaints is levodopa refractory FOG. Levodopa refractoriness will be defined as lack of subjective improvement on FOG episodes as reported by the patient. * Documented dopaminergic response * Optimized PD treatment including dopaminergic medications, and/or deep brain stimulation (DBS) therapy * Presence of at least two self-reported levodopa refractory episodes of FOG per day, not limited to start hesitation * At least one witnessed freezing event during the screening visit in the 'on' medication state (defined as 45 minutes after a regular dose of Levodopa for the subject being studied) Exclusion Criteria: Presence of any co-morbid psychiatric illness(es) that would interfere with the completion of the study or pose risk to the patient, as defined below: * Presence of psychosis * Depression BDI \>14 * Anxiety BAI \>14 * Presence of an active infection, uncontrolled diabetes mellitus, immunosuppression or other medical contraindications to undergoing SCS implantation * Patients who are currently on anticoagulation treatment or unable to hold off the anticoagulants (including Plavix, Aspirin, Warfarin, etc.) 7 days prior to the SCS procedure. * Moderate Cognitive Impairment defined by a MoCA \< 23 * Diagnosis of failed back surgery syndrome, Complex Regional Pain Syndrome (CRPS) or intractable low back pain and leg pain. * Women of childbearing potential will be excluded as from participation due to the limited safety data of thoracic SCS on the fetus.
Where this trial is running
New York, New York and 1 other locations
- Columbia University — New York, New York, United States (Recruiting)
- Baylor College of Medicine — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Nora Vanegas, MD — Baylor College of Medicine
- Study coordinator: Nora Vanegas, MD
- Email: Nora.VanegasArroyave@bcm.edu
- Phone: 713-798-2273
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.