NCT07179406

The Effect of Spinal Cord Stimulators on Restless Leg Syndrome

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

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

Interventions

Type	Name	Description
OTHER	H-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.
OTHER	Somatosensory 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.
OTHER	Vibratory 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.
OTHER	Transcranial 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.
OTHER	Spinal Cord Stimulator (SCS) manipulation	Spinal cord stimulator will be turned on/off

Timeline

• Start date: 2025-08-04
• Primary completion: 2028-01-31
• Completion: 2028-12-31
• First posted: 2025-09-17
• Last updated: 2026-01-30

Locations

1 site across 1 country: United States