Restless Leg Syndrome (RLS), Spinal Cord Stimulation (SCS)
Conditions
Keywords
RLS, SCS
Brief summary
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.
Detailed description
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.
Interventions
DEVICESpinal Cord Stimulation
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.
Sponsors
Marshall Holland
National Institute of Neurological Disorders and Stroke (NINDS)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age \>18 years and older. 2. Received a medical diagnosis of RLS via first screening with Cambridge Hopkins- RLS questionnaire and confirmed via Hopkins-Hening Diagnostic questionnaire. 3. IRLS Scale score ≥ 21 (classified as severe) and received a determination of treatment refractory RLS or inadequate response to standard medical treatment for RLS by a sleep medicine physician. 4. RLS symptoms occur ≥ 3 nights per week. 5. Willing and able to comply with study procedures. 6. Able to provide informed consent.
Exclusion criteria
1. Age \<18 years. 2. Neuropathic pain, other than RLS on DN4 questionnaire. 3. Any mental or physical limitation that would prevent completing and of the study protocols. 4. Active medical implant in the body (i.e., pacemaker). 5. History of prior SCS trial or implantation. 6. Currently using another device to treat RLS. 7. Unable or unwilling to comply with study protocols. 8. Other medical conditions that would put the subject at risk as determined by the investigators. 9. Pregnant, breastfeeding, or trying to become pregnant. 10. Currently participating or plans to participate in any other investigational clinical evaluation during the study period that may, in the opinion of the investigators, affect RLS. 11. Ferritin \< 50 ng/mL (excludes iron deficiency). 12. HgA1C \> 7.5 (excludes unstable diabetes melilitus) 13. One or more of the following diagnoses: spinal cord injury or prior spinal surgery, severe peripheral neuropathy, severe psychiatric or cognitive disorder that may interfere with study participation, history of drug or alcohol abuse within the past year, epilepsy or seizure disorder, current active or chronic infection other than common cold, malignancy within the past 5 years (not including basal cell or squamous cell skin cancer), severe movement disorder (i.e., Parkinson's disease), deep vein thrombosis, multiple sclerosis, known or suspected allergy to SCS materials.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Adverse Events | Baseline through 24 months | Frequency, severity, and relationship of device-, stimulation-, and procedure-related adverse events. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in International Restless Legs Syndrome Scale (IRLS) | Baseline through 24 months | 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. |
| Clinician Global Impression Improvement Scale (CGI-I) | Baseline through 24 months | — |
| Patient Global Impression of Improvement (PGI-I) | Baseline through 24 months | 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. |
| Suggested Immobilization Test (SIT) | Baseline through 24 months | — |
| PROMIS Sleep, Pain, Anxiety, Depression, Cognition, and Health Measures | Baseline through 24 months | — |
| Changes in Neurophysiological Measures of Spinal Cord Stimulation Response | Baseline through 24 months | Changes in H-reflexes, somatosensory evoked potentials (SSEPs), EEG measures, and device-recorded ECAPs. |
| Patient-Reported Outcomes Measurement Information System - Sleep | Baseline through 24 months | 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 |
| Patient-Reported Outcomes Measurement Information System - Pain | Baseline through 24 months | 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 |
| Patient-Reported Outcomes Measurement Information System - Anxiety | Baseline through 24 months | 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. |
| Patient-Reported Outcomes Measurement Information System - Depression | Baseline through 24 months | 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. |
| Patient-Reported Outcomes Measurement Information System - Cognition | Baseline through 24 months | 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. |
| Patient-Reported Outcomes Measurement Information System - Mental health battery | Baseline through 24 months | 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 |
| Patient-Reported Outcomes Measurement Information System - Physical Health Battery | Baseline through 24 months | 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 |
Countries
United States
Contacts
CONTACTChris Gonzalez
PRINCIPAL_INVESTIGATORMarshall Holland, MD
University of Alabama at Birmingham
Outcome results
None listed