Actively Recruiting
The Effect of Spinal Cord Stimulators on Restless Leg Syndrome
Led by University of Alabama at Birmingham · Updated on 2026-01-30
50
Participants Needed
1
Research Sites
177 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The Effect of Spinal Cord Stimulators on Restless Leg Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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 affect RLS
- One or more of the following diseases: spinal cord injury, severe peripheral neuropathy or radiculopathy, severe psychiatric or cognitive disorder, history of drug or alcohol abuse within the past year, epilepsy or seizure disorder, active or chronic infection other than the common cold, malignancy within the past 5 years (excluding certain skin cancers), severe movement disorder such as Parkinson's disease, deep vein thrombosis, or multiple sclerosis
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
Actively Recruiting
Research Team
M
Marshall Holland, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
4
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