This prospective, single-center, first-in-indication feasibility study will evaluate the safety and preliminary effectiveness of spinal cord stimulation (SCS) for the treatment of severe, treatment-refractory primary Restless Legs Syndrome (RLS). Participants will undergo implantation of the Saluda Medical Evoke® Spinal Cord Stimulation System and will be followed for 24 months with clinical, neurophysiological, and patient-reported outcome assessments.
Restless Legs Syndrome (RLS) is a chronic neurological disorder characterized by an urge to move the legs that disrupts sleep and quality of life. Current medical therapies often lose effectiveness over time or are associated with significant side effects. Preliminary case reports suggest that spinal cord stimulation (SCS) may improve RLS symptoms. This single-arm feasibility study will enroll up to 15 adults with severe, treatment-refractory primary RLS. Participants will undergo baseline clinical, neuropsychological, and electrophysiological assessments followed by implantation of the Saluda Medical Evoke® Spinal Cord Stimulation System. Follow-up evaluations will occur through 24 months post-activation. Primary outcomes focus on device and procedure safety. Secondary outcomes evaluate changes in RLS severity, patient-reported outcomes, neurophysiological biomarkers, and device utilization.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Implantation of the FDA-approved Saluda Medical Evoke® Spinal Cord Stimulation System with Smartloop® Technology. Two percutaneous epidural leads will be implanted in the thoracic spine (T7-T10 region) and programmed to provide chronic spinal cord stimulation for treatment of severe RLS symptoms.
UAB Hospital
Birmingham, Alabama, United States
Safety and Adverse Events
Frequency, severity, and relationship of device-, stimulation-, and procedure-related adverse events.
Time frame: Baseline through 24 months
Change in International Restless Legs Syndrome Scale (IRLS)
The IRLS is a validated 10-item patient-reported measure of Restless Legs Syndrome severity. Scores range from 0 to 40, with higher scores indicating worse symptom severity. A decrease in score from baseline indicates improvement.
Time frame: Baseline through 24 months
Clinician Global Impression Improvement Scale (CGI-I)
Time frame: Baseline through 24 months
Patient Global Impression of Improvement (PGI-I)
The PGI-I is a patient-reported global rating of change in symptoms and overall condition following treatment. Scores range from 1 to 7, where 1 = Very much improved and 7 = Very much worse. Lower scores represent a better outcome and greater perceived improvement.
Time frame: Baseline through 24 months
Suggested Immobilization Test (SIT)
Time frame: Baseline through 24 months
PROMIS Sleep, Pain, Anxiety, Depression, Cognition, and Health Measures
Time frame: Baseline through 24 months
Changes in Neurophysiological Measures of Spinal Cord Stimulation Response
Changes in H-reflexes, somatosensory evoked potentials (SSEPs), EEG measures, and device-recorded ECAPs.
Time frame: Baseline through 24 months
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Patient-Reported Outcomes Measurement Information System - Sleep
Questionnaire assessing perceived sleep quality and difficulty falling asleep during the previous 7 days. Responses are converted to PROMIS standardized T-scores. Higher scores indicate greater sleep disturbance and a worse outcome. The T-score range is approximately 20 to 80
Time frame: Baseline through 24 months
Patient-Reported Outcomes Measurement Information System - Pain
Questionnaire assessing the impact of pain on daily activities and sleep during the previous 7 days. Responses are converted to PROMIS standardized T-scores. Higher scores indicate greater pain interference and a worse outcome. The T-score range is approximately 30 to 80
Time frame: Baseline through 24 months
Patient-Reported Outcomes Measurement Information System - Anxiety
Questionnaire assessing fear, anxious mood, and anxiety-related symptoms during the previous 7 days. Responses are converted to PROMIS standardized T-scores. Higher scores indicate greater anxiety and a worse outcome. The T-score range is approximately 40 to 85.
Time frame: Baseline through 24 months
Patient-Reported Outcomes Measurement Information System - Depression
Questionnaire assessing depressive symptoms, negative mood, and diminished self-worth during the previous 7 days. Responses are converted to PROMIS standardized T-scores. Higher scores indicate greater depressive symptom burden and a worse outcome. The T-score range is approximately 40 to 85.
Time frame: Baseline through 24 months
Patient-Reported Outcomes Measurement Information System - Cognition
Questionnaire assessing perceived cognitive abilities including memory, concentration, and mental acuity. Responses are converted to PROMIS standardized T-scores . Higher scores indicate better cognitive functioning and a better outcome. The T-score range is approximately 20 to 80.
Time frame: Baseline through 24 months
Patient-Reported Outcomes Measurement Information System - Mental health battery
Assesses overall mental health. Responses are converted to PROMIS standardized T-scores. Higher scores indicate better overall health status and a better outcome. T-score range is approximately 20 to 80
Time frame: Baseline through 24 months
Patient-Reported Outcomes Measurement Information System - Physical Health Battery
Assesses Overall Physical Health. Responses are converted to PROMIS standardized T-scores. Higher scores indicate better overall health status and a better outcome. T-score range is approximately 20 to 80
Time frame: Baseline through 24 months