N/A
N=15
Spinal Cord Stimulation for Restless Legs Syndrome
Restless Legs Syndrome · Neuropathic Pain
Bottom Line
View on ClinicalTrials.gov: NCT03539081 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Sep 2023
Primary outcome: Primary: Percent Change MSNA Burst Frequency From Baseline to 60 Minutes — -29; -24 Percent change MSNA burst frequency
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Dual-energy X-ray absorptiometry Scan (Diagnostic_test); Laboratory Measurements (Other); Blood Flow Measurement (Other); Continuous Blood Pressure (Other); Partial pressure of oxygen (Other); Microneurography (Other); Anthropometric Measurements (Other); John Hopkins Restless Legs Severity Scale (Behavioral); Continuous Blood Pressure Diary (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Marshall Holland
- Primary completion
- Apr 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change MSNA Burst Frequency From Baseline to 60 Minutes |
-29; -24 | — |
| PRIMARY Response Measurement of Thoracolumbar Epidural SCS in the Femoral Artery Blood Flow |
24; 22 | — |
Summary
The overall goal of this proposed study is to evaluate the underlying mechanisms of neural control of blood flow in the lower extremities in humans with restless leg syndrome (RLS). At least 15% of the general public suffers from RLS and many more may go undiagnosed. This unfortunate disorder leads primarily to a disturbing sensation within the patient's lower extremities that requires movement for relief (1, 2). The central hypothesis of our study is that physiological changes in lower limb blood flow as a result of thoracolumbar epidural Spinal Cord Stimulation (SCS) lead to the relief of RLS.
Eligibility Criteria
Inclusion Criteria
- Mental capacity to understand and decide to participate in the research
- Recently have undergone or are planning to undergo SCS implantation (thoracolumbar region) for chronic pain.
Exclusion Criteria
- Peripheral vascular disease
- History of ischemic heart disease ( examples myocardial infarction, cardiac bypass surgery, coronary stent, unstable angina)
- Heart transplantation
- Renal Failure
- Congestive heart failure
- Type 1 diabetes
- Pregnancy
Data sourced from ClinicalTrials.gov (NCT03539081). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.