Neuromodulation to Overcome Severe Restless Legs Syndrome
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMarshall Holland
About this trial
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 criteria
Qualifiers
Age >18 years and older.
Received a medical diagnosis of RLS via first screening with Cambridge Hopkins- RLS questionnaire and confirmed via Hopkins-Hening Diagnostic questionnaire.
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.
RLS symptoms occur ≥ 3 nights per week.
Disqualifiers
Age <18 years.
Neuropathic pain, other than RLS on DN4 questionnaire.
Any mental or physical limitation that would prevent completing and of the study protocols.
Active medical implant in the body (i.e., pacemaker).
Trial design
Treatments tested in this trial
- Spinal Cord Stimulation
Treatment groups
15 Participants
are divided into 1 treatment groupSponsors and collaborators
Marshall Holland
Lead sponsor
University of Alabama at Birmingham
Sponsor institution
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator
Source ClinicalTrials.gov