The Effect of Spinal Cord Stimulators on Restless Leg Syndrome

ConditionsRestless Leg Syndrome (RLS)Spinal Cord Stimulation (SCS)

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

This trial accepts healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

H-Reflex
Other intervention
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)
Other intervention
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)
Other intervention
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)
Other intervention
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
Other intervention
Spinal cord stimulator will be turned on/off

Treatment groups

50 Participants

are divided into 4 treatment groups

Group A: Arm 1: Assessments and questionnaires onlyActive comparator 4 interventions

Group B: Arm 2: Off-on-offActive comparator 5 interventions

Group C: Arm 3: Off-on-off post-opActive comparator 5 interventions

Group D: Arm 4: On-off-onActive comparator 5 interventions