Evidence map›Paper›PMID 37458698›Full record

Trial reportSleep2023

Efficacy and safety of tonic motor activation (TOMAC) for medication-refractory restless legs syndrome: a randomized clinical trial.

Richard K Bogan, Asim Roy, Jerrold Kram, Joseph Ojile, Russell Rosenberg, J Douglas Hudson, H Samuel Scheuller, John W Winkelman, Jonathan D Charlesworth

3 registry-linked trialsOpen access · hybridAbstract readRandomized Controlled TrialMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Sleep, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 17 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 4 pooled it
3.9field-weighted citation impact, top 6% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04874155 nacompletednot on this map

A Multi-Center, Randomized, Double-Blind, Sham-Controlled Study to Evaluate the NTX100 Neuromodulation System for Patients With Medication-Refractory Primary Restless Legs Syndrome (RLS) - The RESTFUL Study

TypeinterventionalSponsorNoctrix Health, Inc.Ran2021 to 2022Enrolled133ConditionsRestless Legs SyndromeArmsNTX100 Neuromodulation System - Active, NTX100 Neuromodulation System - Sham, NTX100 Neuromodulation System - Open-Label
NCT06076499 active not recruitingnot on this map

A Post-Market Observational Clinical Study to Determine the Long-Term Effectiveness and Safety of the Noctrix TOMAC (Tonic Motor Activation) System for the Treatment of Restless Legs Syndrome - The THRIVE Study

TypeobservationalSponsorNoctrix Health, Inc.Ran2023 to 2027Enrolled325ConditionsRestless Legs SyndromeArmsNTX100
NCT07144631 narecruitingnot on this mapstarted 2025, after this paper: background citation

PENS-P: Peroneal Electrical Nerve Stimulation in Pregnancy for Restless Legs Syndrome (RLS)

TypeinterventionalSponsorRhode Island HospitalRan2025 to 2026Enrolled15ConditionsRestless Leg Disorder, Restless Leg Syndrome (RLS), Pregnancy, Sleep Disorder (Disorder)ArmsPeroneal Nerve Stimulation (PNS) Device
3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 4 syntheses or guidelines pooled it, 18 citations in OpenAlex.

  1. Pooled it
  2. Treatment of restless legs syndrome and periodic limb movement disorder: an American Academy of Sleep Medicine systematic review, meta-analysis, and GRADE assessment.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2025
    Pooled it
  3. Pooled it
  4. Pooled it
  5. Trial
  6. Trial
  7. Article
  8. Observational
  9. Review
  10. Article
  11. The evolving treatment landscape of restless legs syndrome.Therapeutic advances in neurological disorders · 2026
    Review
  12. Article
  13. Article
  14. Review
  15. Article
  16. Article
  17. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors at 7 institutions in 1 country.

Richard K BoganBogan Sleep Consultants, LLC, Columbia, SC, USA.ORCID 0000-0001-7043-2974
Asim RoyOhio Sleep Medicine Institute, Dublin, OH, USA.
Jerrold KramCalifornia Center for Sleep Disorders, San Leandro, CA, USA.
Joseph OjileClayton Sleep Institute, LLC, St. Louis, MO, USA.
Russell RosenbergNeuroTrials Research Inc., Atlanta, GA, USA.
J Douglas HudsonFutureSearch Trials of Neurology, Austin, TX, USA.
H Samuel ScheullerDelta Waves, Inc., Colorado Springs, CO, USA.
John W WinkelmanMassachusetts General Hospital, Boston, MA, USA.
Jonathan D CharlesworthNoctrix Health, Inc., Pleasanton, CA, USA.ORCID 0000-0002-6651-0009
California Center for Sleep Disorders · USClayton Sleep Institute · USDelta Air Lines (United States) · USFutures Group (United States) · USMassachusetts General Hospital · USNeuroTrials Research (United States) · USSleep Management Institute · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

STUDY

objectivesThe purpose of this study was to evaluate the efficacy and safety/tolerability of bilateral high-frequency tonic motor activation (TOMAC) in patients with medication-refractory restless legs syndrome (RLS).

methodsRESTFUL was a multicenter, randomized, double-blind, sham-controlled trial in adults with medication-refractory moderate-to-severe primary RLS. Participants were randomized 1:1 to active or sham TOMAC for a double-blind, 4-week stage 1 and all received active TOMAC during open-label, 4-week stage 2. The primary endpoint was the Clinical Global Impressions-Improvement (CGI-I) responder rate at the end of stage 1. Key secondary endpoints included change to International RLS Study Group (IRLS) total score from study entry to the end of stage 1.

resultsA total of 133 participants were enrolled. CGI-I responder rate at the end of stage 1 was significantly greater for the active versus sham group (45% vs. 16%; Difference = 28%; 95% CI 14% to 43%; p = .00011). At the end of stage 2, CGI-I responder rate further increased to 61% for the active group. IRLS change at the end of stage 1 improved for the active versus sham group (-7.2 vs. -3.8; difference = -3.4; 95% CI -1.4 to -5.4; p = .00093). There were no severe or serious device-related adverse events (AEs). The most common AEs were mild discomfort and mild administration site irritation which resolved rapidly and reduced in prevalence over time.

conclusionsTOMAC was safe, well tolerated, and reduced symptoms of RLS in medication-refractory patients. TOMAC is a promising new treatment for this population. CLINICAL TRIAL: Noninvasive Peripheral Nerve Stimulation for Medication-Refractory Primary RLS (The RESTFUL Study); clinicaltrials.gov/ct2/show/NCT04874155; Registered at ClinicalTrials.gov with the identifier number NCT04874155.

Indexed as

Restless Legs SyndromeAdultDopamine AgonistsDouble-Blind MethodHumansSeverity of Illness IndexTreatment OutcomeDopamine Agonistsbioelectronicneurological disorderneuromodulationperipheral nerve stimulationrestless legs syndromesleep disorder

Identifiers

PMID37458698
PMCPMC10566236
OpenAlexW4384626863

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.