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NCT07179406 | RECRUITING | Restless Leg Syndrome (RLS)

The Effect of Spinal Cord Stimulators on Restless Leg Syndrome
Sponsor:

University of Alabama at Birmingham

Information provided by (Responsible Party):

Marshall Holland

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.

Condition or disease

Restless Leg Syndrome (RLS)

Spinal Cord Stimulation (SCS)

Intervention/treatment

H-Reflex

Somatosensory evoked potential (SSEP)

Vibratory Electrophysiological Response Potential (ERP)

Transcranial Magnetic Stimulation (TMS)

Spinal Cord Stimulator (SCS) manipulation

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 50 participants
Masking : NONE
Primary Purpose : BASIC_SCIENCE
Official Title : The Effect of Spinal Cord Stimulators on Restless Leg Syndrome
Actual Study Start Date : 2026-01-31
Estimated Primary Completion Date : 2027-01-31
Estimated Study Completion Date : 2027-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
Criteria
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.
The Effect of Spinal Cord Stimulators on Restless Leg Syndrome

Location Details

NCT07179406

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Locations

RECRUITING

United States, Albama

University of Alabama at Birmingham

Birmingham, Albama, United States, 35233