The Effect of Spinal Cord Stimulators on Restless Leg Syndrome
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Alabama at Birmingham
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- H-Reflex
- Somatosensory evoked potential (SSEP)
- Vibratory Electrophysiological Response Potential (ERP)
- Transcranial Magnetic Stimulation (TMS)
- Spinal Cord Stimulator (SCS) manipulation
Treatment groups
50 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov