0794 Reduction in Restless Legs Syndrome Symptoms with Non-Invasive Peripheral Nerve Stimulation

Abstract Introduction Restless Legs Syndrome (RLS) is a sensorimotor neurological condition characterized by an uncontrollable urge to move the legs that interferes with falling and staying asleep. For the over 5 million Americans with clinically significant RLS, these symptoms occur multiple nights per week, significantly impair quality of life, increase the prevalence of depression and anxiety, and increase suicide risk. FDA-approved medications for RLS are associated with progressively worsening RLS symptoms and numerous adverse events, whereas existing medical device treatments have limited efficacy. Methods We evaluated a novel neurostimulation intervention for RLS developed by Noctrix Health; electrical stimulation was applied non-invasively and bilaterally to the peroneal nerve of patients with moderate-to-severe primary RLS. Stimulation parameters were engineered to maximize therapeutic efficacy while minimizing interference with sleep. To assess the therapeutic efficacy of this technique, we conducted a multi-site randomized patient-blinded crossover trial comparing active neurostimulation treatment to a sham device. Following a lab visit for calibration, optimization, and training, each patient was instructed to self-administer each treatment - active and sham - for 14 consecutive nights at home. Results Active neurostimulation treatment resulted in a clinically significant reduction in RLS severity of 4.2 points on the International RLS Rating Scale (IRLS) relative to sham (P<0.01), comparable to FDA-approved medications. Moreover, 79% of patients demonstrated a clinically significant improvement on the Clinical Global Impressions-Improvement scale (CGI-I) compared to 7% for sham (P<0.01). Conclusion To our knowledge, this is the first sham-controlled study demonstrating a clinically significant reduction in RLS severity resulting from a non-pharmacological intervention. This therapeutic effect was sustained over 2-weeks of in-home patient-administered usage, indicating consistent efficacy. A medical device based on this technology could be a promising alternative or complement to medications. Support Funding was provided by Noctrix Health, Inc.

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Minimal clinically significant change for the International Restless Legs Syndrome Study Group rating scale in clinical trials is a score of 3

Sleep Medicine ◽

10.1016/j.sleep.2013.08.001 ◽

2013 ◽

Vol 14 (11) ◽

pp. 1229 ◽

Cited By ~ 13

Author(s):

Richard P. Allen

Keyword(s):

Clinical Trials ◽

Restless Legs Syndrome ◽

Rating Scale ◽

Study Group ◽

Clinically Significant Change ◽

Restless Legs ◽

Significant Change ◽

Clinically Significant ◽

Group Rating

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The Relationship between Restless Legs Syndrome and Quality of Life in Patients with Myasthenia Gravis

European Neurology ◽

10.1159/000502002 ◽

2019 ◽

Vol 81 (3-4) ◽

pp. 205-208

Author(s):

Monica F. Ataide ◽

Carolina da Cunha-Correia ◽

Katia C.L. Petribú

Keyword(s):

Quality Of Life ◽

Myasthenia Gravis ◽

Restless Legs Syndrome ◽

Rating Scale ◽

Cross Sectional Study ◽

Cross Sectional ◽

Restless Legs ◽

Study Population ◽

Clinical Conditions

Background: Restless legs syndrome (RLS) is characterized for an uncomfortable sensation in legs and an irresistible desire to move them. This disorder has been more recently recognized in patients with myasthenia gravis (MG) and can interfere with the quality of life (QOL). Objectives: The aims of this study are to describe the prevalence of RLS and its severity and influence on the QOL in patients with MG. Method: This was a cross-sectional study conducted from May to June 2016 in Recife, Brazil. A sample of 42 patients was interviewed using a sociodemographic questionnaire, MG QOL questionnaire-15 and The RLS Rating Scale. Results: RLS was present in 47.6% of patients and of these 40.5% met moderate to severe RLS criteria. Patients were 45 years on average (SD ± 14.4) and women represented 57.1% of the study population. Among patients with RSL, the quality-of-life scores were worse (p = 0.010) on average. There was no association of RLS with the duration of MG, use of immunosuppressant or clinical conditions that could mimic the occurrence of RLS. Conclusion: RLS is a prevalent condition in patients with MG, and may be severe enough to negatively impact QOL.

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The effect of electroacupuncture on hemodialysis patients with restless legs syndrome (RLS): study protocol for a randomized crossover trial

10.21203/rs.3.rs-32357/v1 ◽

2020 ◽

Author(s):

Jia-Ming Chen ◽

Ping-Fang Chiu ◽

Yu-Jun Chang ◽

Po-Chi Hsu ◽

Chia-Chu Chang ◽

...

Keyword(s):

Restless Legs Syndrome ◽

Rating Scale ◽

Severity Index ◽

Hemodialysis Patients ◽

Restless Legs ◽

The Subject ◽

Group 2 ◽

And Control ◽

The Relationship ◽

Registration Date

Abstract Background The aim of the present study was to evaluate the effects of electroacupuncture (EA) in hemodialysis patients with restless leg syndrome (RLS) by heart rate variability (HRV) monitor. Methods112 subjects who were hemodialysis patients with RLS will be divided into 2 groups: experimental and control. Each subject will receive the treatment relevant to their group 2 times a week for 4 weeks. After 4 weeks of treatment the subject will enter a 2-week washout period, after which the subjects will switch groups. Measurements will include HRV recordings, International Restless Legs Syndrome Rating Scale (IRLSRS) and Insomnia Severity Index (ISI). DiscussionThis study is the first investigation to analyze the relationship between EA and the change of HRV by an objective monitor. If the findings of the current trial are positive, this study will also help support an effective, safe and cheap approach to clinical treatment of this challenging disorder, help foster improved understanding the relationship between RLS and HRV, and ultimately contribute to elucidate the mechanisms of EA. Trial registrationClinicalTrials.gov Identifier: NCT04356794; registration date: April 22, 2020.

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International Restless Legs Syndrome Study Group Rating Scale--Japanese Version

PsycTESTS Dataset ◽

10.1037/t71774-000 ◽

2013 ◽

Author(s):

Yuichi Inoue ◽

Yasunori Oka ◽

Tatsuo Kagimura ◽

Kenji Kuroda ◽

Koichi Hirata

Keyword(s):

Restless Legs Syndrome ◽

Rating Scale ◽

Japanese Version ◽

Study Group ◽

Restless Legs ◽

Group Rating

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SP439EXERCISE TRAINING AND DOPAMINE AGONISTS IN HEMODIALYSIS PATIENTS WITH RESTLESS LEGS SYNDROME. A RANDOMIZED DOUBLE-BLIND PLACEBO CONTROLLED STUDY

Nephrology Dialysis Transplantation ◽

10.1093/ndt/gfv194.03 ◽

2015 ◽

Vol 30 (suppl_3) ◽

pp. iii523-iii524

Author(s):

Giorgos Sakkas ◽

Christoforos Giannaki ◽

Christina Karatzaferi ◽

Georgios M. Hadjigeorgiou ◽

Ioannis Stefanidis

Keyword(s):

Restless Legs Syndrome ◽

Dopamine Agonists ◽

Hemodialysis Patients ◽

Controlled Study ◽

Double Blind ◽

Double Blind Placebo ◽

Restless Legs

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Cannabis Use for Restless Legs Syndrome and Uremic Pruritus in in patients treated with maintenance dialysis: A Survey

Canadian Journal of Kidney Health and Disease ◽

10.1177/2054358120954944 ◽

2020 ◽

Vol 7 ◽

pp. 205435812095494

Author(s):

Daniel Samaha ◽

Trisha Kandiah ◽

Deborah Zimmerman

Keyword(s):

Restless Legs Syndrome ◽

Rating Scale ◽

Symptom Relief ◽

Tertiary Care ◽

Current Treatment ◽

Cannabis Use ◽

Care Hospital ◽

Restless Legs ◽

Ottawa Hospital ◽

Uremic Pruritus

Background: Restless legs syndrome (RLS) and uremic pruritus reduce the quality of life in patients with end-stage kidney disease (ESKD) and current treatments are often insufficient. There is an increasing interest in using cannabinoids for symptom management, and preliminary evidence suggests cannabinoids may help alleviate RLS and pruritus. Objectives: (1) To assess the frequency and severity of RLS and pruritus in our ESKD population with the current treatment options, (2) to estimate patient use of cannabinoids for these symptoms, and (3) to determine interest in participating in future trials to treat RLS and/or pruritus. Design: Survey. Patients: Adult prevalent patients with ESKD treated with dialysis at the Ottawa Hospital. Measurements: International RLS Study Group Rating Scale and visual analogue scale for symptom severity of RLS and pruritus, respectively. Methods: Eligible patients with ESKD treated at the Ottawa Hospital were invited to complete a survey to identify symptoms and severity of RLS and pruritus using validated scales, cannabis use for management, and interest in future trials. Basic demographic statistics to describe the study population and results were used. Results: Sixty-nine percent (192 of 277) of eligible patients completed the surveys, 35 declined participation, and 50 surveys were not returned. Eighty-six (45%) and 129 patients (67%) reported symptoms of RLS and pruritus, respectively. Only 18 previously symptomatic patients were relieved with current treatment. Fifteen patients reported cannabis use for symptoms; 9 noted improvement. Most (>2 of 3) symptomatic patients were interested in participating in a future trial. Limitations: Single-center study in a tertiary-care hospital in Canada limiting generalizability. Quoted prevalence of symptoms is dependent on survey return. Conclusions: A large proportion of ESKD patients suffer from RLS and/or pruritus, most of which are not relieved by existing treatments. Few patients reported trying cannabis to decrease their symptoms despite legalization. This study confirms strong patient interest for future trials regarding cannabis for symptom relief. Trial Registration: Not applicable.

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Pramipexole in peritoneal dialysis patients with restless legs syndrome (RLS): a protocol for a multicentre double-blind randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2019-033815 ◽

2020 ◽

Vol 10 (2) ◽

pp. e033815

Author(s):

Tian-tian Ma ◽

Zhikai Yang ◽

Sainan Zhu ◽

Jing-hong Zhao ◽

Yi Li ◽

...

Keyword(s):

Clinical Trial ◽

Peritoneal Dialysis ◽

Restless Legs Syndrome ◽

Rating Scale ◽

Controlled Trial ◽

Psychological Status ◽

Controlled Clinical Trial ◽

Double Blind ◽

Restless Legs ◽

Peking University

IntroductionRestless legs syndrome (RLS) is a common neurological sensorimotor disorder among patients with end stage renal disease. This clinical trial aimed to provide evidence on the efficacy and safety of pramipexole in patients with uremic RLS receiving peritoneal dialysis (PD).Methods and analysisThis is a 12-week, multicentre, randomised, double-blind, placebo-controlled clinical trial. In total, 104 patients with uremic RLS receiving PD will be enrolled from four hospitals and randomly assigned in a 1:1 ratio to either placebo or pramipexole. We will determine the efficacy of pramipexole in the improvement of International RLS Study Group Rating Scale as the primary outcome, while responder rates for other RLS scales at week 12, change from baseline to week 12 for psychological status, sleep disorder and quality of life and blood pressure represent the secondary outcomes.Ethics and disseminationThe study was approved by the ethics committees of Peking University First Hospital, Xinqiao hospital of Army Medical University, Cangzhou Center Hospital and Peking University Shenzhen Hospital. The results will be disseminated in peer-reviewed journals.Trial registration numberNCT03817554

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Prevalence and risk factors of restless legs syndrome in patients of migraine without aura

International Journal of Advances in Medicine ◽

10.18203/2349-3933.ijam20195169 ◽

2019 ◽

Vol 6 (6) ◽

pp. 1706

Author(s):

Karthik Nagaraj ◽

Ramesh Patil

Keyword(s):

Sleep Quality ◽

Restless Legs Syndrome ◽

Migraine Without Aura ◽

Rating Scale ◽

Depression Scale ◽

Anxiety And Depression ◽

Poor Sleep ◽

Poor Sleep Quality ◽

Restless Legs ◽

Midas Questionnaire

Background: An association between migraine and Restless Legs Syndrome (RLS) has been proposed due to shared dopaminergic dysfunction. Both have substantial effects on the quality of life. Identifying co morbidities of migraine helps in optimizing patient management. Objectives To study the prevalence of RLS in patients of migraine without aura, and associated co morbidities of RLS.Methods: This was a hospital based prospective observational study. All patients diagnosed as Migraine without aura as per ICHD-3 criteria completed the questions regarding migraine headache, Migraine Disability Assessment (MIDAS) questionnaire, Hospital Anxiety and Depression Scale (HADS), Pittsburgh Sleep Quality Index (PSQI) and International RLS Study Group (IRLSSG) Rating Scale. RLS was diagnosed using the IRLSSG criteria. Serological investigations were done to look for secondary causes of RLS.Results: Out of 200 consecutive patients of migraine without aura were included in the study over a period of 18 months. Frequency of RLS was 13.5% (n=27). All patients had primary RLS. Mean PSQI score was higher in the patients of migraine without aura with RLS than in non RLS patients of migraine without aura (3.30±2.66 vs 2.24±2.03 p≤0.0168). Poor sleep quality, anxiety, depression was found in 9%, 8% and 2.5% respectively in patients of migraine without aura.Conclusions: An association between migraine without aura and RLS was demonstrated. Migraine without aura was associated with increased frequency of poor sleep quality, anxiety and depression.

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