RecruitingNot ApplicableNCT07179406

The Effect of Spinal Cord Stimulators on Restless Leg Syndrome

Sponsor

University of Alabama at Birmingham

Enrollment

50 participants

Start Date

Aug 4, 2025

Study Type

INTERVENTIONAL

Conditions

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

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria5

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 Criteria7

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.

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Interventions

OTHERH-Reflex

H-reflex - A small electrical stimulus is provided to the leg and foot area and a measurement of the stimulus is taken by the EEG electrodes.

OTHERSomatosensory evoked potential (SSEP)

A small electrical stimulus is provided to a nerve on the body and measured at several places along the nervous system (spinal cord, brain, etc.) with the EMG and EEG electrodes.

OTHERVibratory Electrophysiological Response Potential (ERP)

stimulation is provided to the ankle with vibration sensations using a device like a buzzer and the recording of the body's responses using the EEG and/or EMG electrodes.

OTHERTranscranial Magnetic Stimulation (TMS)

A small magnetic pulse is used to provide a small amount of electrical stimulation to the nervous system. The EEG and/or EMG electrodes will be used to measure the body's reaction.

OTHERSpinal Cord Stimulator (SCS) manipulation

Spinal cord stimulator will be turned on/off