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

NCT05214963 | Completed FDA Device

• 2 other identifiers: CT-02R44NS117294
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Restless Legs Syndrome

Outcome Measures

Primary Outcomes (3)

• Tolerability based on Withdrawal Rate

  Percentage of subjects who withdraw from study citing lack of tolerability of the study device as the primary reason for withdrawal

  2 weeks

• Actigraphy-Based Sleep Efficiency

  The ratio of wake after sleep onset to total sleep time, as measured by actigraphy

  1 week

• Actigraphy-Based Total Sleep Time

  Total sleep duration, as measured by actigraphy

  1 week

Secondary Outcomes (9)

• Frequency of Device Usage

  2 weeks

• Grade 2 or higher device-related adverse events

  2 weeks

• Grade 3 or higher device-related adverse events

  2 weeks

• Polysomnography-Based Sleep Efficiency

  1 night

• Polysomnography-Based Total Sleep Time

  1 night

Other Outcomes (8)

• Medical Outcomes Study Sleep Problems Index II (MOS-II) score

  2 weeks

• Medical Outcomes Study Sleep Problems Index I (MOS-I) score

  2 weeks

• Actigraphy-Based Sleep Onset Latency

  2 weeks

Study Arms (2)

Active neurostimulation

ACTIVE COMPARATOR

Noninvasive peripheral nerve stimulation device programmed to deliver active stimulation

Device: NTX100 Neuromodulation System - Active

Sham neurostimulation

SHAM COMPARATOR

Noninvasive peripheral nerve stimulation device programmed to deliver non-therapeutic (sham) stimulation

Device: NTX100 Neuromodulation System - Sham

Interventions

NTX100 Neuromodulation System - Active DEVICE

Noninvasive peripheral nerve stimulation device programmed to active mode

Active neurostimulation

NTX100 Neuromodulation System - Sham DEVICE

Noninvasive peripheral nerve stimulation device programmed to sham mode

Sham neurostimulation

Eligibility Criteria

• Age: 22 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 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

Sponsors & Collaborators

• Noctrix Health, Inc.: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (3)

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

Clayton Sleep Institute

St Louis, Missouri, 63123, United States

Location

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
• Masking Details: Single-blind \[Participant\]
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized 1:1 between Active treatment and Sham control

Study Record Dates

• First Submitted: January 18, 2022
• First Posted: January 31, 2022
• Study Start: March 8, 2022
• Primary Completion: July 24, 2023
• Study Completion: October 24, 2023
• Last Updated: December 15, 2023

Record last verified: 2023-12

Locations

US (3)