NCT07179406 · University of Alabama at Birmingham
The Effect of Spinal Cord Stimulators on Restless Leg Syndrome
What this study is 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 treatment group$1. treatment group$1 1 are individuals diagnosed with RLS and Healthy Controls.
View original scientific description
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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Birmingham, Alabama
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 26, 2026 · Source of record for eligibility and locations