Peroneal Nerve Stimulation for Restless Legs Syndrome

(PENS-P Trial)

Overseen By Vesna Buntak, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Rhode Island Hospital

Disqualifiers: Preterm labor, Neuromuscular disorders, DVT, others

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

Compensation: Varies

Number of Visits: 6

Duration: 8 weeks

15 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a device that stimulates a leg nerve (Peroneal Electrical Nerve Stimulation) can safely and effectively help pregnant women with Restless Legs Syndrome (RLS) sleep better. Participants use the device at home for 30-minute sessions, up to four times a day, over eight weeks. Pregnant women with a single baby, between 21 and 26 weeks, and diagnosed with RLS may be suitable candidates. Participants will track their symptoms and sleep quality and attend follow-ups to ensure the treatment's safety for both mother and baby. As an unphased trial, this study offers a unique opportunity to contribute to understanding a new treatment option for RLS during pregnancy.

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

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that peroneal nerve stimulation is safe for pregnant women with Restless Legs Syndrome?

Research has shown that peroneal nerve stimulation (PNS) is generally safe and well-tolerated. In earlier studies, the TOMAC™ device, a type of PNS, treated restless legs syndrome (RLS) with positive results. Users experienced fewer RLS symptoms, and the treatment was considered safe.

While limited safety information exists for pregnant women using PNS, the safety record in other groups is encouraging. Patients reported no major side effects, suggesting that PNS might safely reduce RLS symptoms. However, since researchers are specifically studying this treatment for pregnant women, more research is needed to confirm its safety for them. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard treatments for Restless Legs Syndrome (RLS), which often involve medications like dopamine agonists or gabapentin, peroneal nerve stimulation offers a non-drug approach. This treatment is distinct because it uses electrical impulses to stimulate the peroneal nerve, potentially reducing RLS symptoms without the side effects associated with medications. Researchers are excited because this method prioritizes maternal-fetal safety, making it particularly appealing for pregnant individuals seeking relief from RLS symptoms. Additionally, it allows for flexible, home-based use, giving patients more control over their symptom management.

What evidence suggests that peroneal nerve stimulation is effective for treating Restless Legs Syndrome in pregnant women?

Research has shown that stimulating the peroneal nerve can help reduce symptoms of Restless Legs Syndrome (RLS). In this trial, participants will receive TOMAC™ peroneal nerve stimulation therapy. Studies have found this therapy to be safe and effective in improving RLS symptoms, even for those who haven't found relief with medications. It also improves sleep quality, often disrupted by RLS. This technique activates certain pathways in the legs, causing muscles to move in a way that eases discomfort. Overall, TOMAC™ offers a promising non-drug option for managing RLS symptoms. ^{3 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for pregnant women experiencing Restless Legs Syndrome (RLS). Participants will use a non-invasive device, complete questionnaires, wear an actigraphy watch, and attend health assessments. Specific eligibility details are not provided.

Inclusion Criteria

Able and willing to provide informed consent

Able and willing to comply with study procedures, including device usage, questionnaires, adherence diaries, and follow-up assessments up to 3 months postpartum

I am 18 years old or older.

Exclusion Criteria

Skin conditions at device application sites

Severe psychiatric conditions (e.g., bipolar disorder, psychosis, severe anxiety or depression) that may interfere with adherence or accurate symptom reporting

I do not have severe untreated sleep disorders other than RLS.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Titration

Supervised in-clinic titration session with uterine contraction and fetal monitoring at ≥28 weeks' gestation

1 session

1 visit (in-person)

Treatment

Participants use the TOMAC™ device at home for 8 weeks, up to four 30-minute sessions per day

8 weeks

Biweekly phone calls, mid-study visit at week 4, final visit at week 8

Follow-up

Participants are monitored for safety and effectiveness after treatment, including a 3-month postpartum safety check

3 months postpartum

1 visit (in-person) at 3 months postpartum

What Are the Treatments Tested in This Trial?

Interventions

• Peroneal Electrical Nerve Stimulation

Trial Overview The study tests if peroneal nerve stimulation (PNS) can treat RLS in pregnancy. It involves using a PNS device for up to four 30-minute sessions daily over 8 weeks to see if it improves sleep quality and reduces RLS symptoms.

How Is the Trial Designed?

Group I: TOMAC™ Peroneal Nerve Stimulation Experimental Treatment 1 Intervention

Participants will receive TOMAC™ peroneal nerve stimulation (PNS) therapy for Restless Legs Syndrome (RLS) during pregnancy. Following a supervised in-clinic titration session with uterine contraction and fetal monitoring at ≥28 weeks' gestation, participants will use the device at home for 8 weeks. Each therapy session lasts 30 minutes and can be performed as many times as needed daily, prioritizing periods of high symptom burden or before bedtime. Outcomes include feasibility, acceptability, adherence and maternal-fetal safety.

Who Is Running the Clinical Trial?

Rhode Island Hospital

Lead Sponsor

Trials

275

Recruited

71,400+

American College of Chest Physicians

Collaborator

Trials

10

Recruited

2,200+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10566236/

Efficacy and safety of tonic motor activation (TOMAC) for ... TOMAC was safe, well tolerated, and reduced symptoms of RLS in medication-refractory patients. TOMAC is a promising new treatment for this population.

2. academic.oup.com academic.oup.com/sleep/article/48/Supplement_1/A396/8135808

0911 Real-World Outcomes of Tonic Motor Activation (TOMAC ... These interim results suggest that TOMAC treatment is safe and effective in real-world treatment of refractory RLS.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1389945725002552

Efficacy and safety of tonic motor activation for the ... TOMAC offers a promising, effective, and tolerable nonpharmacological option for managing RLS, significantly improving symptom severity and sleep quality.

4. jcsm.aasm.org jcsm.aasm.org/doi/10.5664/jcsm.10536

Bilateral high-frequency noninvasive peroneal nerve ... These results demonstrate that NPNS reduces RLS symptoms by activating afferent pathways, thereby generating tonic and sustained leg muscle activity without ...

5. carepartnersct.com carepartnersct.com/cpct-pdoc-tonic-motor

Activation for the Treatment of Restless Leg Syndrome The stimulation causes the muscles in the lower leg to contract and relax in a specific pattern which can help relieve RLS symptoms in people.

6. trialx.com trialx.com/clinical-trials/listings/325282/peroneal-electrical-nerve-stimulation-in-pregnancy-for-restless-legs-syndrome/

Peroneal Electrical Nerve Stimulation in Pregnancy for ... The goal of this clinical trial is to learn if peroneal nerve stimulation (PNS) can be a feasible, acceptable, and safe way to treat Restless ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT07144631?term=wearable

Peroneal Electrical Nerve Stimulation in Pregnancy for ... An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain amount of ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S1389945724003885

Efficacy and safety of TOMAC for treatment of medication- ... TOMAC reduces restless legs syndrome (RLS) symptoms. TOMAC is efficacious for both medication-refractory and -naïve RLS patients. TOMAC is safe and well ...

9. trial.medpath.com trial.medpath.com/clinical-trial/80b240438b0f646e/nct07144631-peroneal-nerve-stimulation-pregnancy-restless-legs-syndrome

Peroneal Electrical Nerve Stimulation in Pregnancy ... - MedPath The goal of this clinical trial is to learn if peroneal nerve stimulation (PNS) can be a feasible, acceptable, and safe way to treat Restless Legs Syndrome (RLS) ...