Evidence map›Paper›PMID 33949942›Full record

Trial reportJournal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine2021

Noninvasive neuromodulation reduces symptoms of restless legs syndrome.

Mark J Buchfuhrer, Fiona C Baker, Haramandeep Singh, Viktoriia Kolotovska, Bahman Adlou, Harnadar Anand, Massimiliano de Zambotti, Mehvish Ismail, Shriram Raghunathan, Jonathan D Charlesworth

3 registry-linked trialsOpen access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine, 2021. 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 14 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 3 pooled it
2.9field-weighted citation impact, top 9% 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.

NCT04700683 nacompletednot on this map

Chronic Efficacy and Usability of Transcutaneous Electrical Nerve Stimulation in Subjects With Restless Leg Syndrome (RLS)

TypeinterventionalSponsorNoctrix Health, Inc.Ran2019 to 2020Enrolled43ConditionsRestless Legs SyndromeArmsNoctrix Health NPNS device v1.0 - Active, Noctrix Health NPNS device v1.0 - Sham
NCT06076499 active not recruitingnot on this mapstarted 2023, after this paper: background citation

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

14 citing papers in PubMed, 3 syntheses or guidelines pooled it, 24 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. Trial
  5. Trial
  6. Trial
  7. Observational
  8. Review
  9. Article
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  12. Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 3 institutions in 1 country.

Mark J BuchfuhrerStanford University School of Medicine, Stanford, California; private practice, Downey, California.
Fiona C BakerCenter for Health Sciences, SRI International, Menlo Park, California.
Haramandeep SinghSleep Medicine Specialists of California, San Ramon, California.
Viktoriia KolotovskaSleep Medicine Specialists of California, San Ramon, California.
Bahman AdlouNoctrix Health, Inc., Oakland, California.
Harnadar AnandNoctrix Health, Inc., Oakland, California.
Massimiliano de ZambottiCenter for Health Sciences, SRI International, Menlo Park, California.
Mehvish IsmailCenter for Health Sciences, SRI International, Menlo Park, California.
Shriram RaghunathanStanford University School of Medicine, Stanford, California; private practice, Downey, California.
Jonathan D CharlesworthNoctrix Health, Inc., Oakland, California.
SRI International · USStanford University · USMenlo School · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

STUDY

objectivesRestless legs syndrome (RLS) is a common neurological disorder characterized by an uncontrollable nocturnal urge to move the legs and often associated with chronic sleep disturbances. The most common treatments for RLS are medications that can have debilitating side effects. Here, we evaluated a novel alternative modality of RLS treatment, noninvasive bilateral electrical stimulation of the common peroneal nerve.

methodsTo assess the impact of this noninvasive peripheral nerve stimulation (NPNS) approach to RLS symptomatology, we conducted a multisite randomized crossover study comparing NPNS to sham. RLS patients with moderate-to-severe RLS (n = 37) self-administered NPNS and sham nightly for 14 days per treatment in randomized order.

resultsNPNS resulted in a reduction in RLS severity of 6.81 points on the International RLS Rating Scale relative to 3.38 for sham (

conclusionsThese results suggest that NPNS could be a promising alternative to pharmacological therapies for RLS and could provide a solution for medication-resistant RLS patients and for medication-naïve RLS patients who are unwilling or unable to take medication. CLINICAL

trial registrationRegistry: ClinicalTrials.gov; Name: Noninvasive Peripheral Nerve Stimulation for Restless Legs Syndrome; URL: https://clinicaltrials.gov/ct2/show/NCT04700683; Identifier: NCT04700683. CITATION: Buchfuhrer MJ, Baker FC, Haramandeep S, et al. Noninvasive neuromodulation reduces symptoms of restless legs syndrome.

Indexed as

Restless Legs SyndromeCross-Over StudiesHumansbioelectronicneurological disorderneuromodulationperipheral nerve stimulationrestless legs syndromesleep disorder

Identifiers

PMID33949942
PMCPMC8656897
OpenAlexW3157368762

What OpenQuestion holds

Textmetadata
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 OpenQuestion graph.