Noninvasive Peripheral Nerve Stimulation for Restless Legs Syndrome

NCT04700683 | Completed FDA Device

• 1 other identifier: RLS-SNS01
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 3

Brief Summary

Prospective multi-site randomized sham-controlled crossover feasibility study evaluating tolerability and efficacy of noninvasive peripheral nerve stimulation (NPNS) for patients with moderate-severe primary Restless Legs Syndrome (RLS). Response to NPNS investigational device was compared to sham control in a 2x2 crossover design such that subjects were assigned to receive 2 weeks of NPNS and 2 weeks of sham, in randomized order.

Conditions

Restless Legs Syndrome

Outcome Measures

Primary Outcomes (1)

• Evaluate the clinical tolerability, usability, and patient response for the prototype device, with the intention of improving overall device performance.

  Subject satisfaction and usability questionnaire

  Weeks 1-2 of each intervention

Secondary Outcomes (4)

• Change from baseline in International Restless Legs Syndrome Study Group Rating Scale (IRLS) score at week 2

  Week 2 of each intervention compared to week prior to study entry

• Change to Summary NRS score of RLS symptom severity

  Weeks 1-2 of each intervention

• Change to Daily NRS score of RLS symptom severity

  Weeks 1-2 of each intervention

• Responder rate on CGI-I scale at week 2 relative to baseline

  Week 2 of each intervention compared to week prior to study entry

Other Outcomes (1)

• Change to NRS score of RLS severity during SIT procedure

  During the 60 minute SIT procedure

Study Arms (2)

Noninvasive Peripheral Nerve Stimulation

ACTIVE COMPARATOR

NPNS device programmed to deliver active stimulation.

Device: Noctrix Health NPNS device v1.0 - Active

Sham control

SHAM COMPARATOR

NPNS device programmed to deliver sham stimulation.

Device: Noctrix Health NPNS device v1.0 - Sham

Interventions

Noctrix Health NPNS device v1.0 - Active DEVICE

Wearable device programmed to deliver electrical stimulation to peripheral nerves of the lower limbs.

Noninvasive Peripheral Nerve Stimulation

Noctrix Health NPNS device v1.0 - Sham DEVICE

Wearable device programmed to deliver sham stimulation.

Sham control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject has moderate-severe RLS symptoms as defined by a score of 15 or greater points on IRLS.
• RLS symptoms are primarily noticeable in the subject's lower legs and/or feet.
• Subject reports having a medical diagnosis of primary idiopathic restless legs syndrome (RLS) or Willis-Ekbom Disorder (WED) OR Investigator has diagnosed the subject with primary idiopathic restless legs syndrome (RLS) or Willis-Ekbom Disorder (WED).
• Subject has experienced RLS symptoms at night on 2 or more nights per week during the previous month.
• On typical dose and schedule of RLS medication (if any), subject typically experiences RLS symptoms on 2 or more nights per week.
• RLS symptoms are primarily in the evening and night.
• Subject owns the necessary equipment to respond to texts, phone calls, and video calls.
• Subject is 18 years of age or older when written informed consent is obtained.
• Subject has signed a valid, Institutional Review Board (IRB)-approved informed consent form, can understand the requirements of the study and instructions for device usage, and can converse in English.

You may not qualify if:

• Subject has RLS that is known to be caused by another diagnosed condition.
• Subject has active implantable medical devices anywhere in the body (including pacemakers), or passive medical devices implanted in the leg.
• Subject has an uncontrolled sleep disorder other than RLS that significantly interferes with their sleep as determined by the trial director or physician.
• Subject has been diagnosed with one of the following conditions: Epilepsy or other seizure disorder, Cellulitis or open sores of the legs, Renal failure, Iron-Deficiency Anemia, Severe movement disorder symptoms (Parkinson's disease, Huntington's disease, dyskinesia, dystonia), Deep Vein Thrombosis, Stage 4-5 Chronic Kidney Disease, Multiple sclerosis, Current, active or acute or chronic infection other than viral upper respiratory tract infections, A malignancy within the past 5 years (not including basal or squamous cell skin cancer)
• Subject is on dialysis or anticipated to start dialysis while participating in the study
• Subject is allergic to electrode gel, polyurethane foam, or lycra.
• Subject has severe edema in lower legs.
• Subject has failed a nerve conduction study prescribed by a physician or has been diagnosed with severe peripheral neuropathy.
• During Visit 1, subject cannot notice the stimulation at the maximal dose or cannot tolerate the stimulation at the minimal effective dose
• Subject selects Statement 2 or is unable to decide which of the following two statements most closely describe their condition: Statement 1: My symptoms are best characterized by a strong or overwhelming urge to move my legs. Moving my legs often results in temporary relief of that urge. Statement 2: My symptoms are best characterized by involuntary leg spasms that happen at regular intervals. These leg spasms can wake me up in the middle of the night."
• Subject has significantly changed medication dose or schedule of antidepressants, sleep medications, or RLS medications within the past 30 days.
• Recent history of alcohol or recreational drug abuse (within the past 6 months).
• Subject has received an investigational drug or device within the last 30 days or is planning to receive an investigational device during the duration of the study.
• Subject has undergone a major surgery (excluding dental work) in the previous 30 days.
• Subject has another medical condition that may affect validity of the study or put the subject at risk as determined by the investigator.

Sponsors & Collaborators

• Noctrix Health, Inc.: lead

Study Sites (3)

Mark J Buchfuhrer private practice

Downey, California, 90241, United States

Location

SRI International Human Sleep Research Lab

Menlo Park, California, 94025, United States

Location

Sleep Medicine Specialists of California

San Ramon, California, 94583, United States

Location

Related Publications (2)

• Charlesworth JD, Adlou B, Singh H, Buchfuhrer MJ. Bilateral high-frequency noninvasive peroneal nerve stimulation evokes tonic leg muscle activation for sleep-compatible reduction of restless legs syndrome symptoms. J Clin Sleep Med. 2023 Jul 1;19(7):1199-1209. doi: 10.5664/jcsm.10536.

  PMID: 36856064 DERIVED

• Buchfuhrer MJ, Baker FC, Singh H, Kolotovska V, Adlou B, Anand H, de Zambotti M, Ismail M, Raghunathan S, Charlesworth JD. Noninvasive neuromodulation reduces symptoms of restless legs syndrome. J Clin Sleep Med. 2021 Aug 1;17(8):1685-1694. doi: 10.5664/jcsm.9404.

  PMID: 33949942 DERIVED

MeSH Terms

Conditions

Restless Legs Syndrome

Condition Hierarchy (Ancestors)

Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Parasomnias; Mental Disorders

Study Officials

• Jonathan D Charlesworth, PhD

  Noctrix Health, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DEVICE FEASIBILITY
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2021
• First Posted: January 8, 2021
• Study Start: July 14, 2019
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: January 8, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)