RECRUITING

The Effect of Spinal Cord Stimulators on Restless Leg Syndrome

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Conditions

Restless Leg Syndrome (RLS)Spinal Cord Stimulation (SCS)SCSSpinal Cord StimulationRLSRestless Leg Syndrome

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

The Effect of Spinal Cord Stimulators on Restless Leg Syndrome

Quick Facts

Study Start:2026-01-31
Study Completion:2027-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07179406

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Has Restless Leg Syndrome
  2. * No major changes in RLS medications in past 4 weeks
  3. * Willing and able to comply with study protocol
  4. * Healthy Controls - No RLS diagnosis
  5. * Ability to provide informed consent
  1. * Any mental or physical limitation that would prevent completing any of the studies
  2. * Currently using another device to treat RLS
  3. * Unable or unwilling to comply with study protocols
  4. * Other medical condition that would put the subject at risk as determined by the investigator
  5. * Pregnant, breastfeeding, or trying to become pregnant
  6. * 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
  7. * 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.

Contacts and Locations

Study Contact

Marshall Holland, MD
CONTACT
2059343411
mtholloand@uabmc.edu

Study Locations (Sites)

University of Alabama at Birmingham
Birmingham, Alabama, 35233
United States

Collaborators and Investigators

Sponsor: University of Alabama at Birmingham

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2026-01-31
Study Completion Date2027-12-31

Study Record Updates

Study Start Date2026-01-31
Study Completion Date2027-12-31

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

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