The Effect of Spinal Cord Stimulators on Restless Leg Syndrome

Overview

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.

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

Primary outcome measures

• Changes in H-reflex neurophysiological activity in response to Spinal Cord Stimulation (SCS) [Time frame: Up to 3 Weeks after consent to the study]
• Changes in Somatosensory Evoked Potential (SSEP) activity in response to Spinal Cord Stimulation (SCS) [Time frame: Up to 3 Weeks after consent to the study]
• Changes in Vibratory Electrophysiological Response Potential (ERP) activity in response to Spinal Cord Stimulation (SCS) [Time frame: Up to 3 Weeks after consent to the study]
• Changes in Transcranial Magnetic Stimulation (TMS) activity in response to Spinal Cord Stimulation (SCS) [Time frame: Up to 3 Weeks after consent to the study]

Secondary outcome measures (3)

• Changes in self-reported RLS symptoms via International Restless Legs Syndrome (IRLSS) Questionnaire [Time frame: Up to 3 Weeks after consent to the study]
• Changes in self-reported pain symptoms via Promis Questionnaire [Time frame: Up to 3 Weeks after consent to the study]
• Changes in self-reported pain symptoms via PainDetect Questionnaire [Time frame: Up to 3 Weeks after consent to the study]

Eligibility criteria

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 participating or planning to participate in any other investigational clinical evaluation during the study period that may, in the opinion of the investigator, affect RLS
• One or more of the following diseases: spinal cord injury, severe peripheral neuropathy or radiculopathy, severe psychiatric or cognitive disorder that may interfere with participation of the study, history of drug or alcohol abuse within the past year, epilepsy or seizure disorder, current active or chronic infection other than the common cold, malignancy within the past 5 years (not including basal cell or squamous cell skin cancer), severe movement disorder (i.e. Parkinson's disease), deep vein thrombosis, or multiple sclerosis.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Non-randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Basic science

Study locations

United States · 1 center

• University of Alabama at Birmingham — Birmingham

Identifiers

NCT: NCT07179406 · IRB-300014915 · UAB

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗