Neuromodulation to Overcome Severe Restless Legs Syndrome

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Marshall Holland
Study ID
NCT07780032
Status
Not Yet Recruiting

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Conditions

  • Restless Leg Syndrome (RLS)
  • Spinal Cord Stimulation (SCS)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Spinal Cord Stimulation — DEVICE
    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.

Study Details

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.

Key Dates

First listed
Aug 21, 2026
Start date
Oct 31, 2026
Status verified
Aug 2026
Primary completion
Oct 31, 2033
Completion
Oct 31, 2034

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: SCS Implant

Primary Outcome Measure

Safety and Adverse Events [ Time Frame: Baseline through 24 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UAB HospitalBirminghamAlabama35233
Chris Gonzalez
[email protected]
2059964318

Find similar trials in Birmingham, AL

By research site
UAB Hospital· Birmingham, AL

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