The Effect of Spinal Cord Stimulators on Restless Leg Syndrome

The University of Alabama at Birmingham

Status: Enrolling

Conditions: Restless Leg Syndrome (RLS); Spinal Cord Stimulation (SCS)

Treatments: Other: Vibratory Electrophysiological Response Potential (ERP); Other: Transcranial Magnetic Stimulation (TMS); Other: H-Reflex; Other: Somatosensory evoked potential (SSEP); Other: Spinal Cord Stimulator (SCS) manipulation

Study type: Interventional

Funder types: Other

Identifiers

NCT07179406

IRB-300014915

UAB (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 4 patient groups

Arm 1: Assessments and questionnaires only

Active Comparator group

Description:

Complete questionnaires on RLS and pain Stimulation: 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 of the ankle with vibration sensations using a device like a buzzer and recording of 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 nervous system. The EEG and/or EMG electrodes will be used to measure body's reaction.

Treatment:

Other: Somatosensory evoked potential (SSEP)

Other: H-Reflex

Other: Transcranial Magnetic Stimulation (TMS)

Other: Vibratory Electrophysiological Response Potential (ERP)

Arm 2: Off-on-off

Active Comparator group

Description:

Participants will turn OFF their SCS at least 48 hours prior to the visit. The assessments listed in Arm 1 will be performed and the SCS will be turned ON for at least 60 minutes before repeating the assessments. Participants may repeat the questionnaires during this waiting period. Finally, the SCS is turned OFF again, this time for at least 30 minutes before repeating the assessments, except for the h-reflex, which will not be needed again. As with before, participants can complete the questionnaires during this waiting period.

Treatment:

Other: Spinal Cord Stimulator (SCS) manipulation

Other: Somatosensory evoked potential (SSEP)

Other: H-Reflex

Other: Transcranial Magnetic Stimulation (TMS)

Other: Vibratory Electrophysiological Response Potential (ERP)

Arm 3: Off-on-off post-op

Active Comparator group

Description:

Participants will perform the same procedures as those in Arm 2, but only after 2-3 weeks from receiving a permanent SCS.

Treatment:

Other: Spinal Cord Stimulator (SCS) manipulation

Other: Somatosensory evoked potential (SSEP)

Other: H-Reflex

Other: Transcranial Magnetic Stimulation (TMS)

Other: Vibratory Electrophysiological Response Potential (ERP)

Arm 4: On-off-on

Active Comparator group

Description:

Participants will have their SCS on for at least 48 hours prior to the visit. The assessments listed in Arm 1 will be performed and the SCS will be turned Off for at least 60 minutes before repeating the assessments. Participants may repeat the questionnaires during this waiting period. Finally, the SCS is turned On again, this time for at least 30 minutes before repeating the assessments, except for the h-reflex, which will not be needed again. As with before, participants can complete the questionnaires during this waiting period.

Treatment:

Other: Spinal Cord Stimulator (SCS) manipulation

Other: Somatosensory evoked potential (SSEP)

Other: H-Reflex

Other: Transcranial Magnetic Stimulation (TMS)

Other: Vibratory Electrophysiological Response Potential (ERP)