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The Effect of Spinal Cord Stimulators on Restless Leg Syndrome
Sponsor: 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.
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
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.
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.
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.
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.
Spinal Cord Stimulator (SCS) manipulation
Spinal cord stimulator will be turned on/off
Locations (1)
University of Alabama at Birmingham
Birmingham, Alabama, United States