Restless Leg DisorderPENS-PNCT07144631
Peroneal Electrical Nerve Stimulation in Pregnancy for Restless Legs Syndrome
A study testing Peroneal Nerve Stimulation (PNS) Device in people with Restless Leg Disorder and Restless Leg Syndrome (RLS), run by Rhode Island Hospital at 2 sites in United States.
Trial summary
The goal of this study is to evaluate whether peroneal electrical nerve stimulation (PNS) using the TOMAC™ device is a feasible, acceptable, and safe non-pharmacologic intervention for managing Restless Legs Syndrome (RLS) during pregnancy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Restless Leg Disorder, Restless Leg Syndrome (RLS), Pregnancy
- What is being tested?
- Peroneal Nerve Stimulation (PNS) Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Oct 2025to 31 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Pregnant individuals between 21 and 26 weeks' gestation at enrollment
- Singleton pregnancy without known fetal anomalies
- Confirmed clinical diagnosis of Restless Legs Syndrome (RLS) according to International Restless Legs Syndrome Study Group (IRLSSG) criteria, confirmed by a sleep medicine specialist to exclude RLS mimics
- 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
Who cannot join
- Pregnancy-related:
- History of preterm labor
- Known fetal anomalies identified prior to enrollment
- Neurological and neuromuscular disorders:
- Pre-existing neuromuscular disorders affecting balance or gait
- Severe peripheral neuropathy involving the lower legs
Show all 25Show fewer
- Epilepsy or history of seizures
- Cardiovascular and circulatory conditions:
- History of deep vein thrombosis (DVT)
- Circulatory conditions contraindicating peroneal nerve stimulation (PNS) device use
- Dermatological conditions:
- Skin conditions at device application sites
- Known allergy to device materials
- Other sleep disorders:
- Inadequately treated severe primary sleep disorders other than RLS (e.g., untreated severe sleep apnea, severe insomnia unrelated to RLS)
- Device and treatment experience exclusions (based on RESTFUL trial criteria):
- Prior use of the study device or any neurostimulation device for RLS treatment
- Presence of active medical implants (e.g., pacemakers, spinal cord stimulators)
- Other medical conditions:
- Participants undergoing dialysis treatment
- Severe psychiatric conditions (e.g., bipolar disorder, psychosis, severe anxiety or depression) that may interfere with adherence or accurate symptom reporting
- Any condition deemed by investigators to pose safety risks or impede participation
- Other exclusions:
- Unable or unwilling to operate the device safely and independently
- Unable to participate reliably in follow-up assessments or complete self-reported diaries
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Not yet recruiting
Rhode Island Hospital
Providence, Rhode Island, 02903
Vesna Buntak, MD, 4017933496, vbuntak@brownhealth.org
Vesna Buntak, MD
- Recruiting
Rhode Island Hospital
Providence, Rhode Island, 02903
About this study
Official title: PENS-P: Peroneal Electrical Nerve Stimulation in Pregnancy for Restless Legs Syndrome (RLS)
The goal of this study is to evaluate whether peroneal electrical nerve stimulation (PNS) using the TOMAC™ device is a feasible, acceptable, and safe non-pharmacologic intervention for managing Restless Legs Syndrome (RLS) during pregnancy. This pilot study will also collect preliminary information on symptom relief, sleep quality, and maternal-fetal safety associated with device use.
The main questions the study aims to answer are:
Read more
Is TOMAC™ PNS a feasible and acceptable intervention for RLS in pregnant individuals? Are there any maternal, fetal, or neonatal safety concerns with PNS use during pregnancy? What are the patterns of adherence, tolerance, and usability of the TOMAC™ device in this population?
Participants will:
Use a non-invasive TOMAC™ peroneal nerve stimulator during 30-minute sessions as needed, for 8 weeks.
Complete questionnaires assessing feasibility, acceptability, symptom severity, and sleep quality (including AIM, IAM, FIM, IRLS, PGI-I, PSQI, ESS, FOSQ, and MOS-II).
Wear an actigraphy monitor to collect objective sleep data at baseline and at 4 weeks.
Attend scheduled follow-up visits and phone check-ins for maternal vital signs, uterine contraction and fetal monitoring, and neonatal outcome assessment.
This is a prospective, open-label, single-arm pilot study enrolling 15 pregnant participants between 21 and 26 weeks' gestation. Findings will provide the first dataset on the feasibility, acceptability, and safety of TOMAC™ PNS in pregnancy and inform the design of a future randomized controlled trial.
Read the detailed description
This is a prospective, open-label, single-arm pilot study designed to assess the feasibility, acceptability, and preliminary safety of TOMAC™ peroneal electrical nerve stimulation (PNS) for the treatment of Restless Legs Syndrome (RLS) during pregnancy.
RLS affects approximately 20-30% of pregnant individuals, with symptoms often worsening during the second and third trimesters. It is associated with disrupted sleep, decreased quality of life, and adverse pregnancy outcomes such as gestational hypertension, preeclampsia, prolonged labor, and increased cesarean delivery rates. Pharmacologic therapies for RLS are generally avoided during pregnancy because of limited data on fetal safety, highlighting the need for effective, non-pharmacologic alternatives.
The TOMAC™ system is a non-invasive, wearable, high-frequency peroneal nerve stimulator that delivers bilateral stimulation to the common peroneal nerves. It is FDA De Novo granted for use in adults with moderate to severe RLS but has not been evaluated in pregnant populations. Safety rationale for this study is informed by evidence from other neuromodulation therapies, such as sacral nerve stimulation, which have been used safely during pregnancy without observed maternal or fetal harm.
Primary objectives are to evaluate the feasibility and acceptability of TOMAC™ PNS using validated implementation measures, including the Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), and Feasibility of Intervention Measure (FIM).
Secondary objectives include assessment of adherence, dose tolerance, usability, maternal and fetal safety, and exploratory evaluation of symptom improvement and sleep quality through the International Restless Legs Syndrome Rating Scale (IRLS), Patient Global Impression of Improvement (PGI-I), Pittsburgh Sleep Quality Index (PSQI), Epworth Sleepiness Scale (ESS), Functional Outcomes of Sleep Questionnaire (FOSQ), and Medical Outcomes Study Sleep Problem Index II (MOS-II).
Fifteen pregnant individuals between 21 and 26 weeks of gestation with a confirmed diagnosis of RLS will be enrolled. Following baseline assessments, participants will undergo an in-person titration session under clinical supervision, which includes uterine contraction and fetal monitoring performed at ≥28 weeks' gestation to ensure maternal and fetal safety.
Participants will then use the TOMAC™ device at home for an 8-week intervention, performing self-administered 30-minute sessions as needed, preferably during periods of symptom distress or prior to sleep.
Data will be collected from patient-reported outcomes, actigraphy sleep recordings, device usage logs, and maternal-fetal safety monitoring. Follow-up includes biweekly phone check-ins, an in-person mid-study visit at week 4, a final in-person visit at week 8, and a three-month postpartum safety follow-up.
This pilot study will generate the first prospective data on the feasibility, acceptability, and safety of peroneal nerve stimulation in pregnancy, providing foundational evidence for future randomized controlled trials evaluating TOMAC™ PNS as a pregnancy-safe, non-pharmacologic treatment for RLS and its potential to improve maternal sleep and pregnancy outcomes.
- Being tested
- Peroneal Nerve Stimulation (PNS) Device
- Keywords
- Restless Legs Syndrome, Pregnancy, Sleep Disorders in Pregnancy, Maternal Sleep Health, Peroneal Nerve Stimulation, Neuromodulation
- Medical subject headings
- Restless Legs Syndrome, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peroneal Nerve Stimulation (PNS) DeviceDevice
The TOMAC™ system is a non-invasive, wearable peroneal nerve stimulator that delivers high-frequency electrical stimulation to the common peroneal nerves at the fibular head. It is FDA-cleared for the treatment of moderate-to-severe Restless Legs Syndrome (RLS) in adults but has not been studied in pregnancy. In this trial, pregnant participants will undergo an in-clinic titration session with uterine contraction and fetal monitoring at ≥28 weeks' gestation to determine comfortable therapeutic intensity. They will then use the device at home for 8 weeks, up to four 30-minute sessions daily, prioritizing periods of high symptom burden or before bedtime. Outcomes will assess feasibility, acceptability, adherence, symptom improvement, sleep quality, and maternal-fetal safety.
| Study group | Role | What they receive |
|---|---|---|
| TOMAC™ Peroneal Nerve Stimulation | Experimental | 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. Receives: Device: Peroneal Nerve Stimulation (PNS) Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of Intervention Measure (AIM) Score
The Acceptability of Intervention Measure (AIM) is a validated 4-item questionnaire assessing participants' perceptions of how acceptable the intervention is. Scores range from 1 to 5. Higher scores indicate greater acceptability.
Measured: Baseline to 8 weeks of intervention
Intervention Appropriateness Measure (IAM) Score
The Intervention Appropriateness Measure (IAM) is a validated 4-item questionnaire assessing participants' perceptions of how appropriate the intervention is for their condition. Scores range from 1 to 5. Higher scores indicate greater appropriateness.
Measured: Baseline and Week 8 of intervention
Feasibility of Intervention Measure (FIM) Score
The Feasibility of Intervention Measure (FIM) is a validated 4-item questionnaire assessing participants' perceptions of how feasible it is to use the intervention. Scores range from 1 to 5. Higher scores indicate greater feasibility.
Measured: Baseline and Week 8 of intervention
Secondary outcomes (15)
Adherence to Maximum Allowed Device Sessions
Adherence will be measured as the proportion of actual device sessions used compared to the maximum allowed use (as many as needed 30-minute sessions for 8 weeks). Data will be collected from device logs and participant diaries. Results will be reported as the percentage of completed sessions relative to the maximum allowable sessions.
Measured: Throughout 8 weeks of intervention
Mean Session Duration
Average duration of each stimulation session, recorded by device logs. Results will be reported in minutes per session.
Measured: Continuous during 8-week intervention
Mean Stimulation Voltage Used During Device Sessions
Average stimulation voltage delivered by the peroneal nerve stimulation (PNS) device during participant sessions, recorded from device logs. Results will be reported as mean voltage across all sessions.
Measured: Continuous during 8-week intervention
Number of Participants With Treatment-Related Adverse Events (AEs)
Number of participants experiencing treatment-emergent adverse events related to device use, as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Results will be reported as total number of participants.
Measured: Throughout 8-week intervention
Number of Participants With Serious Adverse Events (SAEs)
Number of participants experiencing serious adverse events related to device use, as assessed by CTCAE v4.0. Results will be reported as total number of participants.
Measured: Throughout 8-week intervention
Change in Maternal Systolic Blood Pressure
Maternal systolic blood pressure measured at in-clinic visits using automated sphygmomanometer. Results will be reported as mean change in millimeters of mercury (mmHg).
Measured: Baseline, Week 4, Week 8
Change in Maternal Diastolic Blood Pressure
Maternal diastolic blood pressure measured at in-clinic visits using automated sphygmomanometer. Results will be reported as mean change in millimeters of mercury (mmHg).
Measured: Baseline, Week 4, Week 8
Change in Maternal Heart Rate
Maternal heart rate measured at in-clinic visits using automated sphygmomanometer. Results will be reported as mean change in beats per minute (bpm).
Measured: Baseline, Week 4, Week 8
Incidence of Uterine Irritability During Titration
Proportion of participants who experience uterine irritability during the in-clinic titration session (≥28 weeks gestation). Uterine irritability is defined per protocol as ≥10 contractions within a 20-minute period, measured using external tocodynamometry. Results will be reported as percentage of participants.
Measured: At ≥28 weeks of pregnancy during titration session
Incidence of Fetal Distress During Titration
Proportion of participants who experience fetal distress during the in-clinic titration session (≥28 weeks gestation). Fetal distress is defined as one or more of the following:
- FHR bradycardia <110 bpm for ≥10 minutes
- FHR tachycardia >160 bpm for ≥10 minutes
- Minimal/absent variability (<5 bpm amplitude for ≥20 minutes)
- Recurrent decelerations (≥3 late or variable decelerations in 20 minutes)
Results will be reported as percentage of participants.
Measured: At ≥28 weeks of pregnancy during titration session
Incidence of Uterine Irritability Associated With Fetal Distress
Proportion of participants who experience both uterine irritability (≥10 contractions in 20 minutes) and concurrent fetal distress during the same titration session, as defined above. Results will be reported as percentage of participants.
Measured: At ≥28 weeks of pregnancy during titration session
Infant Birth Weight
Infant birth weight measured at delivery. Results will be reported in grams.
Measured: At delivery
Neonatal Apgar Score at 1 Minute
Neonatal Apgar score assessed at 1 minute after delivery. Scores range from 0 to 10, with higher scores indicating better neonatal condition. Results will be reported as mean score.
Measured: At delivery (1 minute)
Neonatal Apgar Score at 5 Minutes
Neonatal Apgar score assessed at 5 minute after delivery. Scores range from 0 to 10, with higher scores indicating better neonatal condition. Results will be reported as mean score.
Measured: At delivery (5 minutes)
Neonatal Health Outcomes at 3 Months Postpartum
Proportion of infants with adverse health outcomes, including but not limited to growth restriction, feeding difficulties, recurrent hospitalizations, or clinician-diagnosed developmental concerns. Outcomes will be reported as percentage of infants, based on maternal report confirmed by pediatric/OB medical records.
Measured: 3 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2025
- Study start15 Oct 2025
- Primary completion30 Sep 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (30)Papers the sponsor has linked to this study.
- Other trials for Restless Leg DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All enrolled participants will receive the same intervention (TOMAC™ peroneal nerve stimulation). There is no randomization to different arms or a control/placebo group in this pilot study.
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rhode Island Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- American College of Chest Physicians
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07144631
- Sponsor's protocol ID
- 2313348
- Acronym
- PENS-P
- Status last verified
- Oct 2025
- First submitted
- 11 Aug 2025
- Last updated
- 12 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Individual participant data (IPD) will not be shared because the study is a small pilot with a limited sample size and data will only be used for the purposes outlined in the approved protocol. The IRB-approved consent form does not include provisions for external data sharing.
Publications
Yoshimura C, Arima H, Amagase H, Takewaka M, Nakashima K, Imaoka C, Miyanaga N, Obama H, Fujita M, Ando SI. Idiopathic and secondary restless legs syndrome during pregnancy in Japan: Prevalence, clinical features and delivery-related outcomes. PLoS One. 2021 May 11;16(5):e0251298. doi: 10.1371/journal.pone.0251298. eCollection 2021.
PubMed 33974646Yaiesh SM, Al-Terki AE, Al-Shaiji TF. Safety of Sacral Nerve Stimulation in Pregnancy: A Literature Review. Neuromodulation. 2016 Oct;19(7):770-779. doi: 10.1111/ner.12450. Epub 2016 Jun 10.
PubMed 27286484Winkelman JW, Berkowski JA, DelRosso LM, Koo BB, Scharf MT, Sharon D, Zak RS, Kazmi U, Falck-Ytter Y, Shelgikar AV, Trotti LM, Walters AS. Treatment of restless legs syndrome and periodic limb movement disorder: an American Academy of Sleep Medicine clinical practice guideline. J Clin Sleep Med. 2025 Jan 1;21(1):137-152. doi: 10.5664/jcsm.11390.
PubMed 39324694Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3.
PubMed 28851459Walters AS, LeBrocq C, Dhar A, Hening W, Rosen R, Allen RP, Trenkwalder C; International Restless Legs Syndrome Study Group. Validation of the International Restless Legs Syndrome Study Group rating scale for restless legs syndrome. Sleep Med. 2003 Mar;4(2):121-32. doi: 10.1016/s1389-9457(02)00258-7.
PubMed 14592342Vahdat M, Sariri E, Miri S, Rohani M, Kashanian M, Sabet A, Zamani B. Prevalence and associated features of restless legs syndrome in a population of Iranian women during pregnancy. Int J Gynaecol Obstet. 2013 Oct;123(1):46-9. doi: 10.1016/j.ijgo.2013.04.023. Epub 2013 Jul 22.
PubMed 23886452Teresi JA, Yu X, Stewart AL, Hays RD. Guidelines for Designing and Evaluating Feasibility Pilot Studies. Med Care. 2022 Jan 1;60(1):95-103. doi: 10.1097/MLR.0000000000001664.
PubMed 34812790Szymanski JK, Slabuszewska-Jozwiak A, Jakiel G. Sacral Neuromodulation in Pregnant Women-A Case Report and Literature Review. Int J Environ Res Public Health. 2022 Jul 8;19(14):8340. doi: 10.3390/ijerph19148340.
PubMed 35886191Steinweg K, Nippita T, Cistulli PA, Bin YS. Maternal and neonatal outcomes associated with restless legs syndrome in pregnancy: A systematic review. Sleep Med Rev. 2020 Dec;54:101359. doi: 10.1016/j.smrv.2020.101359. Epub 2020 Jul 10.
PubMed 32805557Srivanitchapoom P, Pandey S, Hallett M. Restless legs syndrome and pregnancy: a review. Parkinsonism Relat Disord. 2014 Jul;20(7):716-22. doi: 10.1016/j.parkreldis.2014.03.027. Epub 2014 Apr 8.
PubMed 24768121Silber MH, Buchfuhrer MJ, Earley CJ, Koo BB, Manconi M, Winkelman JW; Scientific and Medical Advisory Board of the Restless Legs Syndrome Foundation. The Management of Restless Legs Syndrome: An Updated Algorithm. Mayo Clin Proc. 2021 Jul;96(7):1921-1937. doi: 10.1016/j.mayocp.2020.12.026.
PubMed 34218864Sawatari H, Yoshimura C, Amagase H, Takewaka M, Nakashima K, Imaoka C, Obama H, Miyanaga N, Ando SI. Relationship between Restless legs syndrome associated symptoms and presence of depression during pregnancy. Women Health. 2022 Mar;62(3):265-271. doi: 10.1080/03630242.2022.2055698. Epub 2022 Mar 30.
PubMed 35354362Salehi-Pourmehr H, Atayi M, Mahdavi N, Aletaha R, Kashtkar M, Sharifimoghadam S, Hassanzadeh R, Hajebrahimi S. Is sacral neuromodulation effective and safe in pregnancy? A systematic review. Neurourol Urodyn. 2023 Aug;42(6):1329-1343. doi: 10.1002/nau.25224. Epub 2023 Jun 8.
PubMed 37288591Roy A, Ojile J, Kram J, Olin J, Rosenberg R, Hudson JD, Bogan RK, Charlesworth JD. Long-term efficacy and safety of tonic motor activation for treatment of medication-refractory restless legs syndrome: A 24-Week Open-Label Extension Study. Sleep. 2023 Oct 11;46(10):zsad188. doi: 10.1093/sleep/zsad188.
PubMed 37439365Rosen H, Yogev Y. Assessment of uterine contractions in labor and delivery. Am J Obstet Gynecol. 2023 May;228(5S):S1209-S1221. doi: 10.1016/j.ajog.2022.09.003. Epub 2023 Mar 19.
PubMed 37164494
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PENS-P: Peroneal Electrical Nerve Stimulation in Pregnancy for Restless Legs Syndrome (RLS)
- ClinicalTrials.gov ID
- NCT07144631
- Acronym / sponsor ID
- PENS-P / 2313348
- Keywords
- Restless Legs Syndrome, Pregnancy, Sleep Disorders in Pregnancy, Maternal Sleep Health, Peroneal Nerve Stimulation, Neuromodulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Rhode Island HospitalUniversity, hospital or other
- Collaborators
- American College of Chest Physicians
- Study start
- 15 Oct 2025 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 27 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to evaluate whether peroneal electrical nerve stimulation (PNS) using the TOMAC™ device is a feasible, acceptable, and safe non-pharmacologic intervention for managing Restless Legs Syndrome (RLS) during pregnancy. This pilot study will also collect preliminary information on symptom relief, sleep quality, and maternal-fetal safety associated with device use.
The main questions the study aims to answer are:
Is TOMAC™ PNS a feasible and acceptable intervention for RLS in pregnant individuals? Are there any maternal, fetal, or neonatal safety concerns with PNS use during pregnancy? What are the patterns of adherence, tolerance, and usability of the TOMAC™ device in this population?
Participants will:
Use a non-invasive TOMAC™ peroneal nerve stimulator during 30-minute sessions as needed, for 8 weeks.
Complete questionnaires assessing feasibility, acceptability, symptom severity, and sleep quality (including AIM, IAM, FIM, IRLS, PGI-I, PSQI, ESS, FOSQ, and MOS-II).
Wear an actigraphy monitor to collect objective sleep data at baseline and at 4 weeks.
Attend scheduled follow-up visits and phone check-ins for maternal vital signs, uterine contraction and fetal monitoring, and neonatal outcome assessment.
This is a prospective, open-label, single-arm pilot study enrolling 15 pregnant participants between 21 and 26 weeks' gestation. Findings will provide the first dataset on the feasibility, acceptability, and safety of TOMAC™ PNS in pregnancy and inform the design of a future randomized controlled trial.
Detailed description
This is a prospective, open-label, single-arm pilot study designed to assess the feasibility, acceptability, and preliminary safety of TOMAC™ peroneal electrical nerve stimulation (PNS) for the treatment of Restless Legs Syndrome (RLS) during pregnancy.
RLS affects approximately 20-30% of pregnant individuals, with symptoms often worsening during the second and third trimesters. It is associated with disrupted sleep, decreased quality of life, and adverse pregnancy outcomes such as gestational hypertension, preeclampsia, prolonged labor, and increased cesarean delivery rates. Pharmacologic therapies for RLS are generally avoided during pregnancy because of limited data on fetal safety, highlighting the need for effective, non-pharmacologic alternatives.
The TOMAC™ system is a non-invasive, wearable, high-frequency peroneal nerve stimulator that delivers bilateral stimulation to the common peroneal nerves. It is FDA De Novo granted for use in adults with moderate to severe RLS but has not been evaluated in pregnant populations. Safety rationale for this study is informed by evidence from other neuromodulation therapies, such as sacral nerve stimulation, which have been used safely during pregnancy without observed maternal or fetal harm.
Primary objectives are to evaluate the feasibility and acceptability of TOMAC™ PNS using validated implementation measures, including the Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), and Feasibility of Intervention Measure (FIM).
Secondary objectives include assessment of adherence, dose tolerance, usability, maternal and fetal safety, and exploratory evaluation of symptom improvement and sleep quality through the International Restless Legs Syndrome Rating Scale (IRLS), Patient Global Impression of Improvement (PGI-I), Pittsburgh Sleep Quality Index (PSQI), Epworth Sleepiness Scale (ESS), Functional Outcomes of Sleep Questionnaire (FOSQ), and Medical Outcomes Study Sleep Problem Index II (MOS-II).
Fifteen pregnant individuals between 21 and 26 weeks of gestation with a confirmed diagnosis of RLS will be enrolled. Following baseline assessments, participants will undergo an in-person titration session under clinical supervision, which includes uterine contraction and fetal monitoring performed at ≥28 weeks' gestation to ensure maternal and fetal safety.
Participants will then use the TOMAC™ device at home for an 8-week intervention, performing self-administered 30-minute sessions as needed, preferably during periods of symptom distress or prior to sleep.
Data will be collected from patient-reported outcomes, actigraphy sleep recordings, device usage logs, and maternal-fetal safety monitoring. Follow-up includes biweekly phone check-ins, an in-person mid-study visit at week 4, a final in-person visit at week 8, and a three-month postpartum safety follow-up.
This pilot study will generate the first prospective data on the feasibility, acceptability, and safety of peroneal nerve stimulation in pregnancy, providing foundational evidence for future randomized controlled trials evaluating TOMAC™ PNS as a pregnancy-safe, non-pharmacologic treatment for RLS and its potential to improve maternal sleep and pregnancy outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All enrolled participants will receive the same intervention (TOMAC™ peroneal nerve stimulation). There is no randomization to different arms or a control/placebo group in this pilot study.
| Arm | Type | Receives |
|---|---|---|
| TOMAC™ Peroneal Nerve Stimulation | Experimental | Device: Peroneal Nerve Stimulation (PNS) DeviceParticipants 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 may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥18 years
- Pregnant individuals between 21 and 26 weeks' gestation at enrollment
- Singleton pregnancy without known fetal anomalies
- Confirmed clinical diagnosis of Restless Legs Syndrome (RLS) according to International Restless Legs Syndrome Study Group (IRLSSG) criteria, confirmed by a sleep medicine specialist to exclude RLS mimics
- Able and willing to provide informed consent
Key exclusion criteria (25 listed)
- History of preterm labor
- Known fetal anomalies identified prior to enrollment
- Pre-existing neuromuscular disorders affecting balance or gait
- Severe peripheral neuropathy involving the lower legs
- Epilepsy or history of seizures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peroneal Nerve Stimulation (PNS) DeviceThe TOMAC™ system is a non-invasive, wearable peroneal nerve stimulator that delivers high-frequency electrical stimulation to the common peroneal nerves at the fibular head. It is FDA-cleared for the treatment of moderate-to-severe Restless Legs Syndrome (RLS) in adults but has not been studied in pregnancy. In this trial, pregnant participants will undergo an in-clinic titration session with uterine contraction and fetal monitoring at ≥28 weeks' gestation to determine comfortable therapeutic intensity. They will then use the device at home for 8 weeks, up to four 30-minute sessions daily, prioritizing periods of high symptom burden or before bedtime. Outcomes will assess feasibility, acceptability, adherence, symptom improvement, sleep quality, and maternal-fetal safety. | Device | TOMAC™ Peroneal Nerve Stimulation |
Primary outcome
Acceptability of Intervention Measure (AIM) Score
Time frame: Baseline to 8 weeks of intervention
The Acceptability of Intervention Measure (AIM) is a validated 4-item questionnaire assessing participants' perceptions of how acceptable the intervention is. Scores range from 1 to 5. Higher scores indicate greater acceptability.
Intervention Appropriateness Measure (IAM) Score
Time frame: Baseline and Week 8 of intervention
The Intervention Appropriateness Measure (IAM) is a validated 4-item questionnaire assessing participants' perceptions of how appropriate the intervention is for their condition. Scores range from 1 to 5. Higher scores indicate greater appropriateness.
Feasibility of Intervention Measure (FIM) Score
Time frame: Baseline and Week 8 of intervention
The Feasibility of Intervention Measure (FIM) is a validated 4-item questionnaire assessing participants' perceptions of how feasible it is to use the intervention. Scores range from 1 to 5. Higher scores indicate greater feasibility.
15 secondary outcomes
Adherence to Maximum Allowed Device Sessions
Time frame: Throughout 8 weeks of intervention
Mean Session Duration
Time frame: Continuous during 8-week intervention
Mean Stimulation Voltage Used During Device Sessions
Time frame: Continuous during 8-week intervention
Number of Participants With Treatment-Related Adverse Events (AEs)
Time frame: Throughout 8-week intervention
Number of Participants With Serious Adverse Events (SAEs)
Time frame: Throughout 8-week intervention
Change in Maternal Systolic Blood Pressure
Time frame: Baseline, Week 4, Week 8
Change in Maternal Diastolic Blood Pressure
Time frame: Baseline, Week 4, Week 8
Change in Maternal Heart Rate
Time frame: Baseline, Week 4, Week 8
Incidence of Uterine Irritability During Titration
Time frame: At ≥28 weeks of pregnancy during titration session
Incidence of Fetal Distress During Titration
Time frame: At ≥28 weeks of pregnancy during titration session
Incidence of Uterine Irritability Associated With Fetal Distress
Time frame: At ≥28 weeks of pregnancy during titration session
Infant Birth Weight
Time frame: At delivery
Neonatal Apgar Score at 1 Minute
Time frame: At delivery (1 minute)
Neonatal Apgar Score at 5 Minutes
Time frame: At delivery (5 minutes)
Neonatal Health Outcomes at 3 Months Postpartum
Time frame: 3 months postpartum
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2025.
- Background: PubMed 33974646Yoshimura C, Arima H, Amagase H, Takewaka M, Nakashima K, Imaoka C, Miyanaga N, Obama H, Fujita M, Ando SI. Idiopathic and secondary restless legs syndrome during pregnancy in Japan: Prevalence, clinical features and delivery-related outcomes. PLoS One. 2021 May 11;16(5):e0251298. doi: 10.1371/journal.pone.0251298. eCollection 2021.
- Background: PubMed 27286484Yaiesh SM, Al-Terki AE, Al-Shaiji TF. Safety of Sacral Nerve Stimulation in Pregnancy: A Literature Review. Neuromodulation. 2016 Oct;19(7):770-779. doi: 10.1111/ner.12450. Epub 2016 Jun 10.
- Background: PubMed 39324694Winkelman JW, Berkowski JA, DelRosso LM, Koo BB, Scharf MT, Sharon D, Zak RS, Kazmi U, Falck-Ytter Y, Shelgikar AV, Trotti LM, Walters AS. Treatment of restless legs syndrome and periodic limb movement disorder: an American Academy of Sleep Medicine clinical practice guideline. J Clin Sleep Med. 2025 Jan 1;21(1):137-152. doi: 10.5664/jcsm.11390.
- Background: PubMed 28851459Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3.
- Background: PubMed 14592342Walters AS, LeBrocq C, Dhar A, Hening W, Rosen R, Allen RP, Trenkwalder C; International Restless Legs Syndrome Study Group. Validation of the International Restless Legs Syndrome Study Group rating scale for restless legs syndrome. Sleep Med. 2003 Mar;4(2):121-32. doi: 10.1016/s1389-9457(02)00258-7.
- Background: PubMed 23886452Vahdat M, Sariri E, Miri S, Rohani M, Kashanian M, Sabet A, Zamani B. Prevalence and associated features of restless legs syndrome in a population of Iranian women during pregnancy. Int J Gynaecol Obstet. 2013 Oct;123(1):46-9. doi: 10.1016/j.ijgo.2013.04.023. Epub 2013 Jul 22.
- Background: PubMed 34812790Teresi JA, Yu X, Stewart AL, Hays RD. Guidelines for Designing and Evaluating Feasibility Pilot Studies. Med Care. 2022 Jan 1;60(1):95-103. doi: 10.1097/MLR.0000000000001664.
- Background: PubMed 35886191Szymanski JK, Slabuszewska-Jozwiak A, Jakiel G. Sacral Neuromodulation in Pregnant Women-A Case Report and Literature Review. Int J Environ Res Public Health. 2022 Jul 8;19(14):8340. doi: 10.3390/ijerph19148340.
- Background: PubMed 32805557Steinweg K, Nippita T, Cistulli PA, Bin YS. Maternal and neonatal outcomes associated with restless legs syndrome in pregnancy: A systematic review. Sleep Med Rev. 2020 Dec;54:101359. doi: 10.1016/j.smrv.2020.101359. Epub 2020 Jul 10.
- Background: PubMed 24768121Srivanitchapoom P, Pandey S, Hallett M. Restless legs syndrome and pregnancy: a review. Parkinsonism Relat Disord. 2014 Jul;20(7):716-22. doi: 10.1016/j.parkreldis.2014.03.027. Epub 2014 Apr 8.
- Background: PubMed 34218864Silber MH, Buchfuhrer MJ, Earley CJ, Koo BB, Manconi M, Winkelman JW; Scientific and Medical Advisory Board of the Restless Legs Syndrome Foundation. The Management of Restless Legs Syndrome: An Updated Algorithm. Mayo Clin Proc. 2021 Jul;96(7):1921-1937. doi: 10.1016/j.mayocp.2020.12.026.
- Background: PubMed 35354362Sawatari H, Yoshimura C, Amagase H, Takewaka M, Nakashima K, Imaoka C, Obama H, Miyanaga N, Ando SI. Relationship between Restless legs syndrome associated symptoms and presence of depression during pregnancy. Women Health. 2022 Mar;62(3):265-271. doi: 10.1080/03630242.2022.2055698. Epub 2022 Mar 30.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared because the study is a small pilot with a limited sample size and data will only be used for the purposes outlined in the approved protocol. The IRB-approved consent form does not include provisions for external data sharing.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peroneal Nerve Stimulation (PNS) Device in people with Restless Leg Disorder and Restless Leg Syndrome (RLS), run by Rhode Island Hospital at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vesna Buntak, MD (4014444000, vbuntak@brownhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of Intervention Measure (AIM) Score (time frame: Baseline to 8 weeks of intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07144631, which also lists 30 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2025.