Noninvasive Peripheral Nerve Stimulation for Medication-Naive and Medication-Refractory RLS

  • STATUS
    Recruiting
  • End date
    Mar 31, 2023
  • participants needed
    40
  • sponsor
    Noctrix Health, Inc.
Updated on 14 May 2022

Summary

Prospective multi-site randomized sham-controlled study evaluating tolerability and efficacy of noninvasive peripheral nerve stimulation (NPNS) for patients with moderate-severe primary Restless Legs Syndrome (RLS) who are either medication-naive or medication-refractory.

Description

The study consists of a series of two 2-week phases:

Phase 1: Baseline evaluation of RLS and sleep Phase 2: Prospective, single-blinded, 1:1 randomized evaluation of response to NPNS treatment (Active treatment: Sham control)

Additionally, subjects will have the option to consent to a third phase, which includes overnight polysomnography (PSG) evaluation of sleep with Active treatment and with no treatment (baseline), in randomized order.

Details
Condition Restless Legs Syndrome
Treatment NTX100 Neuromodulation System - Active, NTX100 Neuromodulation System - Sham
Clinical Study IdentifierNCT05214963
SponsorNoctrix Health, Inc.
Last Modified on14 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Subject has received a medical diagnosis of primary restless legs syndrome (RLS)
Subject is either medication-naïve or medication-refractory
Subject has moderate-severe RLS symptoms as defined by a score of 15 or greater points on IRLS (International Restless Legs Syndrome Study Group Rating Scale) over the week prior to study entry
RLS symptoms interfered with sleep on at least 3 nights per week during the month prior to study entry
RLS symptoms are most significant in the subject's lower legs and/or feet
RLS symptoms are most significant after 6pm
Subject agrees to not change dosage or schedule of any medications that are known to impact RLS symptoms during the study, including RLS medications, antidepressants, sleep medications, or sedative antihistamines
Subject agrees to not make major lifestyle changes during the study that would significantly affect bedtime, such as major changes to diet, exercise, or career
Subject possesses the necessary equipment, internet/phone accessibility, and communication ability to complete electronic questionnaires and respond to electronic communications and phone calls from the research staff throughout the in-home portion of the study
Subject is ≥ 22 and ≤ 89 years of age when written informed consent is obtained
Subject has signed a valid, IRB-approved informed consent form, can understand the requirements of the study and instructions for device usage, and can converse in English

Exclusion Criteria

Subject has RLS that is known to be caused by another diagnosed condition (i.e. secondary RLS)
Subject is taking an unstable or inconsistent dose or schedule of medication that is likely to impact RLS symptoms, such as antidepressants, sleep medications, or sedative antihistamines or has changed dosage within the past 30 days
Subject has changed dose and schedule of RLS medications within the month prior to study entry or is otherwise on an inconsistent dose or schedule of RLS medications
Subject has prior experience with Noctrix Health NPNS devices
Subject was misdiagnosed with RLS, as determined by the investigator (e.g. actual diagnosis of PLMD, arthritis, leg spasms or neuropathy without comorbid RLS)
Subject has a primary sleep disorder other than RLS that significantly interferes with sleep at the present time (e.g. obstructive sleep apnea stably controlled via CPAP would not be an exclusion)
Subject has active medical device implant anywhere in the body (including but not limited to pacemakers, spinal cord stimulators, deep brain stimulators) or metal implant at the site of study device electrode application
Subject has severe peripheral neuropathy affecting the lower legs and/or subject has neuropathy and is unable to clearly distinguish between symptoms of neuropathy and symptoms of RLS
Subject has been diagnosed with one of the following conditions
Epilepsy or other seizure disorder
Current, active or acute or chronic infection other than common cold
A malignancy within the past 5 years (not including basal or squamous cell skin cancer)
Stage 4-5 chronic kidney disease or renal failure
Severe movement disorder symptoms (Parkinson's disease, Huntington's disease, dyskinesia, dystonia)
Deep vein thrombosis
Multiple sclerosis
Subject has moderate or severe cognitive disorder or mental illness
Subject has current diagnosis of iron-deficient anemia or history of iron-deficient anemia within the past year
Subject has known allergy to device materials or severe previous reaction to medical adhesives or bandages
Subject has severe edema affecting lower legs
Subject has any of the following at or near the location of device application
Acute injury
Cellulitis
Open sores
Other skin condition
Subject is on dialysis or anticipated to start dialysis while participating in the
study
During the NTX100 calibration process, which is identical for subjects in the active and sham arms, subject reports not feeling stimulation sensations up to an intensity of 30mA, the subject finds stimulation intensities less than 15 mA to be uncomfortable or distracting, or the device does not properly fit the subject
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 is pregnant or trying to become pregnant
Subject has undergone a major surgery (excluding dental work) in the previous 30 days
Subject is unable or unwilling to comply with study requirements
Subject has another medical condition that may put the subject at risk as determined by the investigator
Subject has another medical condition that may affect validity of the study as determined by the investigator
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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