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Neuromodulation to Overcome Severe Restless Legs Syndrome

Not Yet RecruitingNA

Sponsor: Marshall Holland

Conditions: Restless Leg Syndrome (RLS), Spinal Cord Stimulation (SCS)

Interventions: Spinal Cord Stimulation

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (1)

Birmingham, Alabama, United States