Spinal Cord Stimulation for Restless Legs Syndrome

Overseen By Marshall Holland, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Spinal cord injury, Severe neuropathy, Psychiatric disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 4-6 weeks

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a spinal cord stimulator to assess its effects on individuals with Restless Legs Syndrome (RLS) and chronic pain. Researchers aim to understand how the device alters brain and nerve activity and whether it alleviates symptoms. Participants fall into four groups: those with only RLS, those with RLS and an existing stimulator, those with RLS about to receive a stimulator, and those with chronic pain but no RLS. Individuals with RLS who have not changed their medications in the last month may be suitable candidates for this trial. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance treatment options for RLS and chronic pain.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop your current medications, but it does require no major changes in your Restless Legs Syndrome medications in the past 4 weeks. It's best to discuss your specific situation with the study team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that spinal cord stimulators (SCS) are generally well-tolerated by people with Restless Legs Syndrome (RLS). In one study, 89% of participants experienced relief from RLS symptoms with SCS, indicating that most felt better after using it. Additionally, SCS is already approved for treating other conditions, such as chronic pain, suggesting its safety for similar uses. Although some studies mention the need for further research to fully recommend SCS for RLS, its current use in other treatments offers some reassurance about its safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about spinal cord stimulation (SCS) for Restless Legs Syndrome (RLS) because it offers a new way to address symptoms by directly targeting the nervous system. Unlike standard treatments like medications that often focus on balancing dopamine or iron levels, SCS involves applying small electrical impulses to the spinal cord, potentially providing relief from RLS symptoms through neuromodulation. This method has the potential to offer a more direct, physical approach to managing RLS symptoms, which could be transformative for patients not responding well to medications. Additionally, the ability to adjust the stimulation settings offers personalized treatment options, which is a significant advancement over current one-size-fits-all medications.

What evidence suggests that this trial's treatments could be effective for Restless Legs Syndrome and chronic pain?

Research has shown that spinal cord stimulation (SCS) may help treat restless legs syndrome (RLS). In studies, about 89% of participants experienced noticeable symptom improvement, as indicated by a drop in their scores on the International Restless Legs Scale (IRLS). This trial will evaluate the effectiveness of SCS in various scenarios, including turning the device on and off at different intervals. SCS could offer a good non-drug option for people with RLS. However, some experts suggest that more research is needed to fully understand its benefits. Overall, SCS appears to be a promising choice for those with RLS who haven't found relief with other treatments. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for individuals with Restless Legs Syndrome (RLS), some of whom may also have chronic pain. Participants can be those already diagnosed with RLS, healthy controls, or people scheduled to receive a Spinal Cord Stimulator (SCS). It's not clear what the exclusion criteria are from the provided information.

Inclusion Criteria

My medication for restless legs syndrome hasn't changed in the last 4 weeks.

Healthy Controls - No RLS diagnosis

Willing and able to comply with study protocol

Exclusion Criteria

I cannot or do not want to follow the study rules.

I have no mental or physical limitations that would stop me from completing the study.

I do not have any severe health conditions that could affect my participation in the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo baseline assessments including EEG, EMG, h-reflex, SSEP, ERP, and TMS under varying SCS conditions

1 week

1 visit (in-person)

Treatment

Participants undergo stimulation procedures with SCS turned on and off, including assessments and questionnaires

4-6 weeks

Multiple visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Spinal Cord Stimulator

Trial Overview

The study tests how different neurophysiological assessments like EEG and EMG respond under various SCS conditions in RLS patients. It has four groups: RLS patients, those with an SCS, those about to get an SCS, and chronic pain patients with an SCS but no RLS.

How Is the Trial Designed?

Group I: Arm 1: Assessments and questionnaires only Active Control 4 Interventions

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.

Group II: Arm 2: Off-on-off Active Control 5 Interventions

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.

Group III: Arm 3: Off-on-off post-op Active Control 5 Interventions

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

Group IV: Arm 4: On-off-on Active Control 5 Interventions

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.

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40652630/

Adaptive spinal cord stimulation improves restless legs ...

Including this case, all but 2 (89 %) demonstrated a clinically significant decrease in IRLS scores (>3 points). Discussion: To our knowledge, ...

2.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1389945725003399

Adaptive spinal cord stimulation improves restless legs ...

Literature review noted 89 % success rate with SCS for co-morbid RLS. •. SCS is a promising emerging alternative, non-medication therapy for RLS.

3.

academic.oup.com

academic.oup.com/painmedicine/article/24/Supplement_2/S18/7313607

Potential therapeutic benefit of spinal cord stimulation in ...

The published evidence is insufficient to assess SCS efficacy in patients with RLS, but SCS remains a promising investigational therapy in RLS ...

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07179406

The Effect of Spinal Cord Stimulators on Restless Leg ...

This study aims to evaluate neurophysiological responses and symptom changes in individuals with Restless Legs Syndrome (RLS) and/or chronic ...

5.

frontiersin.org

frontiersin.org/journals/neurology/articles/10.3389/fneur.2023.1219881/full

Spinal cord stimulation in severe pharmacoresistant ...

While all the above cases demonstrate a good efficacy of SCS on self-rated RLS symptoms, objective, polysomnographic data on sleep structure and ...

6.

karger.com

karger.com/sfn/article/97/1/31/293673/Spinal-Cord-Stimulation-for-Restless-Legs-Syndrome

Spinal Cord Stimulation for Restless Legs Syndrome

This is the first reported case of using SCS as a potentially long-lasting, safe, and highly effective therapy for RLS of mixed etiology.