Health TrialsbyHealthPanel

Neuromodulation to Overcome Severe Restless Legs Syndrome

ConditionsRestless Leg Syndrome (RLS)Spinal Cord Stimulation (SCS)
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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

15 Participants
are divided into 1 treatment group
Group A: SCS ImplantExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Safety and Adverse Events

Frequency, severity, and relationship of device-, stimulation-, and procedure-related adverse events.

Time frame
Baseline through 24 months

Secondary outcomes

1

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
2

Clinician Global Impression Improvement Scale (CGI-I)

Time frame
Baseline through 24 months
3

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
4

Suggested Immobilization Test (SIT)

Time frame
Baseline through 24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Marshall Holland

Lead sponsor

University of Alabama at Birmingham

Sponsor institution

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: