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The Effect of Spinal Cord Stimulators on Restless Leg Syndrome | Clinical Trials | Clareo Health

RECRUITINGNA

The Effect of Spinal Cord Stimulators on Restless Leg Syndrome

NCT07179406•University of Alabama at Birmingham

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

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.

Locations (1)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Key Dates

Start Date

August 4, 2025

Primary Completion Date

January 31, 2028

Completion Date

December 31, 2028

Last Updated

January 30, 2026

Enrollment

ESTIMATED participants

Conditions

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

Interventions

H-Reflex

OTHER

Somatosensory evoked potential (SSEP)

OTHER

Vibratory Electrophysiological Response Potential (ERP)

OTHER

Transcranial Magnetic Stimulation (TMS)

OTHER

Spinal Cord Stimulator (SCS) manipulation

OTHER

Contacts

Marshall Holland, MD

CONTACT

2059343411 mtholloand@uabmc.edu

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 30, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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The Effect of Spinal Cord Stimulators on Restless Leg Syndrome

Inclusion Criteria

Exclusion Criteria

Severe Chronic Neuropathic Pain: A Treatment Bundle, Using Spinal Cord Stimulation and Multidisciplinary Treatment, to Reduce Pain and Improve Physical Function.

Observe Change in Nasal Swab DRD2 Gene Expression in Restless Legs Syndrome (RLS) Patients on Prolonged Dopamine Agonist Treatment

Effects of PNF Stretching vs Conventional Physical Therapy on the Symptoms of Restless Leg Syndrome in Elderly Population.

Combined Effects of Near-Infrared Light and Vibration on Diabetic Patients With Restless Leg Syndrome

Validating the Use of a Subjectively Reported Sleep Vital Sign