Restless Leg Syndrome (RLS)NO RLSNCT07780032
Neuromodulation to Overcome Severe Restless Legs Syndrome
A study testing Spinal Cord Stimulation in people with Restless Leg Syndrome (RLS) and Spinal Cord Stimulation (SCS), run by Marshall Holland at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Restless Leg Syndrome (RLS), Spinal Cord Stimulation (SCS)
- What is being tested?
- Spinal Cord Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2027to Oct 2034
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Willing and able to comply with study procedures.
- Able to provide informed consent.
Who cannot join
- 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).
- History of prior SCS trial or implantation.
- Currently using another device to treat RLS.
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- Unable or unwilling to comply with study protocols.
- Other medical conditions that would put the subject at risk as determined by the investigators.
- Pregnant, breastfeeding, or trying to become pregnant.
- 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.
- Ferritin < 50 ng/mL (excludes iron deficiency).
- HgA1C > 7.5 (excludes unstable diabetes melilitus)
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
UAB Hospital
Birmingham, Alabama, 35233
Chris Gonzalez, 2059964318, clgonzalez@uabmc.edu
About this study
Official title: Neuromodulation to Overcome Severe Restless Legs Syndrome (NO RLS)
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.
Read the 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.
- Being tested
- Spinal Cord Stimulation
- Keywords
- RLS, SCS
- Medical subject headings
- Restless Legs Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal Cord StimulationDevice
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 group | Role | What they receive |
|---|---|---|
| SCS Implant | Experimental | Not described Receives: Device: Spinal Cord Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Adverse Events
Frequency, severity, and relationship of device-, stimulation-, and procedure-related adverse events.
Measured: Baseline through 24 months
Secondary outcomes (13)
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.
Measured: Baseline through 24 months
Clinician Global Impression Improvement Scale (CGI-I)
Measured: Baseline through 24 months
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.
Measured: Baseline through 24 months
Suggested Immobilization Test (SIT)
Measured: Baseline through 24 months
PROMIS Sleep, Pain, Anxiety, Depression, Cognition, and Health Measures
Measured: Baseline through 24 months
Changes in Neurophysiological Measures of Spinal Cord Stimulation Response
Changes in H-reflexes, somatosensory evoked potentials (SSEPs), EEG measures, and device-recorded ECAPs.
Measured: Baseline through 24 months
Patient-Reported Outcomes Measurement Information System - Sleep
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
Measured: Baseline through 24 months
Patient-Reported Outcomes Measurement Information System - Pain
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
Measured: Baseline through 24 months
Patient-Reported Outcomes Measurement Information System - Anxiety
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.
Measured: Baseline through 24 months
Patient-Reported Outcomes Measurement Information System - Depression
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.
Measured: Baseline through 24 months
Patient-Reported Outcomes Measurement Information System - Cognition
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.
Measured: Baseline through 24 months
Patient-Reported Outcomes Measurement Information System - Mental health battery
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
Measured: Baseline through 24 months
Patient-Reported Outcomes Measurement Information System - Physical Health Battery
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
Measured: Baseline through 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2026
- Study startOct 2027 (estimated)
- Primary completionOct 2033 (estimated)
- Study completionOct 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Restless Leg Syndrome (RLS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marshall Holland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Marshall Holland, University of Alabama at Birmingham
- Investigators
- Marshall Holland, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07780032
- Sponsor's protocol ID
- IRB-300013464
- Other IDs
- 1UG3NS145980-01
- Acronym
- NO RLS
- Status last verified
- Oct 2026
- First submitted
- 7 Aug 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromodulation to Overcome Severe Restless Legs Syndrome (NO RLS)
- ClinicalTrials.gov ID
- NCT07780032
- Acronym / sponsor ID
- NO RLS / IRB-300013464
- Keywords
- RLS, SCS
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Marshall HollandUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- Oct 2027 (estimated)
- Primary completion
- Oct 2033 (estimated)
- Study completion
- Oct 2034 (estimated)
- First posted
- 21 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SCS Implant | Experimental | Device: Spinal Cord Stimulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
- Willing and able to comply with study procedures.
Key exclusion criteria (13 listed)
- 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).
- History of prior SCS trial or implantation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spinal Cord StimulationImplantation 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. | Device | SCS Implant |
Primary outcome
Safety and Adverse Events
Time frame: Baseline through 24 months
Frequency, severity, and relationship of device-, stimulation-, and procedure-related adverse events.
13 secondary outcomes
Change in International Restless Legs Syndrome Scale (IRLS)
Time frame: Baseline through 24 months
Clinician Global Impression Improvement Scale (CGI-I)
Time frame: Baseline through 24 months
Patient Global Impression of Improvement (PGI-I)
Time frame: Baseline through 24 months
Suggested Immobilization Test (SIT)
Time frame: Baseline through 24 months
PROMIS Sleep, Pain, Anxiety, Depression, Cognition, and Health Measures
Time frame: Baseline through 24 months
Changes in Neurophysiological Measures of Spinal Cord Stimulation Response
Time frame: Baseline through 24 months
Patient-Reported Outcomes Measurement Information System - Sleep
Time frame: Baseline through 24 months
Patient-Reported Outcomes Measurement Information System - Pain
Time frame: Baseline through 24 months
Patient-Reported Outcomes Measurement Information System - Anxiety
Time frame: Baseline through 24 months
Patient-Reported Outcomes Measurement Information System - Depression
Time frame: Baseline through 24 months
Patient-Reported Outcomes Measurement Information System - Cognition
Time frame: Baseline through 24 months
Patient-Reported Outcomes Measurement Information System - Mental health battery
Time frame: Baseline through 24 months
Patient-Reported Outcomes Measurement Information System - Physical Health Battery
Time frame: Baseline through 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marshall Holland, MD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spinal Cord Stimulation in people with Restless Leg Syndrome (RLS) and Spinal Cord Stimulation (SCS), run by Marshall Holland at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chris Gonzalez (2059964318, clgonzalez@uabmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Adverse Events (time frame: Baseline through 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.