The Effect of Spinal Cord Stimulators on Restless Leg Syndrome
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 range
- 18+ 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 par…
Interventions
- OtherH-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.
- OtherSomatosensory 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.
- OtherVibratory 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.
- OtherTranscranial 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.
- OtherSpinal Cord Stimulator (SCS) manipulation
Spinal cord stimulator will be turned on/off
Location
- University of Alabama at BirminghamBirmingham, Alabama