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RECRUITING
NCT07179406
NA

The Effect of Spinal Cord Stimulators on Restless Leg Syndrome

Sponsor: University of Alabama at Birmingham

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2025-08-04

Completion Date

2028-12-31

Last Updated

2026-01-30

Healthy Volunteers

Yes

Interventions

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

Locations (1)

University of Alabama at Birmingham

Birmingham, Alabama, United States