The Effect of Spinal Cord Stimulators on Restless Leg Syndrome

Not Applicable

Recruiting

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

• Registration Number: NCT07179406
• Lead Sponsor: University of Alabama at Birmingham

Brief Summary

This study aims to evaluate neurophysiological responses and symptom changes in individuals with Restless Legs Syndrome (RLS) and/or chronic pain. Participants will undergo standard clinical assessments including EEG, EMG, h-reflex, SSEP, ERP, and TMS under varying SCS conditions.The study involves 4 arms. Arm 1 are individuals diagnosed with RLS and Healthy Controls. Arm 2 are individuals diagnosed with RLS and have an existing SCS. Arm 3 are individuals diagnosed with RLS and scheduled to receive a SCS. Arm 4 are individuals with chronic pain and have a SCS, but no diagnosis of RLS.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-08-28
• Status Verified: 2025-09
• Study First Submitted QC: 2025-09-10
• Last Update Submitted: 2025-09-10
• Study First Posted: 2025-09-17
• Last Update Posted: 2025-09-17
• Study Start: 2026-01-31
• Primary Completion: 2027-01-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Has Restless Leg Syndrome
• No major changes in RLS medications in past 4 weeks
• Willing and able to comply with study protocol
• Healthy Controls - No RLS diagnosis
• Ability to provide informed consent

Exclusion Criteria

• Any mental or physical limitation that would prevent completing any of the studies
• Currently using another device to treat RLS
• Unable or unwilling to comply with study protocols
• Other medical condition that would put the subject at risk as determined by the investigator
• Pregnant, breastfeeding, or trying to become pregnant
• Currently participating or planning to participate in any other investigational clinical evaluation during the study period that may, in the opinion of the investigator, affect RLS
• One or more of the following diseases: spinal cord injury, severe peripheral neuropathy or radiculopathy, severe psychiatric or cognitive disorder that may interfere with participation of the study, history of drug or alcohol abuse within the past year, epilepsy or seizure disorder, current active or chronic infection other than the 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, or multiple sclerosis.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Changes in H-reflex neurophysiological activity in response to Spinal Cord Stimulation (SCS)	Up to 3 Weeks after consent to the study
Changes in Somatosensory Evoked Potential (SSEP) activity in response to Spinal Cord Stimulation (SCS)	Up to 3 Weeks after consent to the study
Changes in Vibratory Electrophysiological Response Potential (ERP) activity in response to Spinal Cord Stimulation (SCS)	Up to 3 Weeks after consent to the study
Changes in Transcranial Magnetic Stimulation (TMS) activity in response to Spinal Cord Stimulation (SCS)	Up to 3 Weeks after consent to the study

Secondary Outcome Measures

Name	Time	Method
Changes in self-reported RLS symptoms via International Restless Legs Syndrome (IRLSS) Questionnaire	Up to 3 Weeks after consent to the study
Changes in self-reported RLS symptoms via RLS-6 Questionnaire	Up to 3 Weeks after consent to the study
Changes in self-reported pain symptoms via Promis Questionnaire	Up to 3 Weeks after consent to the study
Changes in self-reported pain symptoms via PainDetect Questionnaire	Up to 3 Weeks after consent to the study

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States