Noninvasive Peripheral Nerve Stimulation for Restless Legs Syndrome During Opioid Medication Reduction

NCT04698343 | Completed Results FDA Device

• 2 other identifiers: CT-03R44NS117294
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 2

Brief Summary

Prospective open-label single-arm feasibility study assessing the tolerability of opioid medication reduction in conjunction with noninvasive peripheral nerve stimulation (NPNS) for patients taking prescription opioids to treat moderate-severe primary RLS.

Conditions

Restless Legs Syndrome

Outcome Measures

Primary Outcomes (1)

• Percentage of Subjects Without a Clinically Significant Increase in RLS Symptoms During the First Phase Involving an Opioid Dose Reduction of >= 20% Relative to Baseline.

  Percentage of subjects without a clinically significant increase in RLS symptoms during the first Phase involving an opioid dose reduction of \>= 20% relative to baseline. The clinically significant increase was assessed by determining the Clinician Global Impression of Improvement (CGI-I) score for the subject. Possible choices (followed by scale value) are: Very much improved (1), Much improved (2), Minimally improved (3), No change (4), Minimally worse (5), Much worse (6), Very Much Worse (7). Scores of 6 or 7 would be considered a clinically significant increase in RLS Symptoms.

  Week 1

Secondary Outcomes (4)

• Percentage of Subjects Without a Clinically Significant Increase in RLS Symptoms During the First Phase Involving an Opioid Dose Reduction of >= 1/3 Relative to Baseline.

  1 week

• Change From Baseline in International Restless Legs Syndrome Study Group Rating Scale (IRLS) Score During Step-down #1 With an Opioid Dose Reduction of >=20%

  1 week

• Change From Baseline in International Restless Legs Syndrome Study Group Rating Scale (IRLS) Score During Step-down #2 With an Opioid Dose Reduction of >=1/3

  1 week into Step-down #2

• Maximum Percent Change in Opioid Dose Relative to Baseline Without a Clinically Significant Increase in RLS Symptoms.

  1 week into final step-down

Other Outcomes (4)

• NPNS Tolerability Rate - Percentage of Subjects Who Withdrew From Optional Phase 3 Citing Lack of Tolerability of NPNS as the Primary Reason for Withdrawal.

  Up to 9 weeks

• Percentage of Grade 2 or Higher NPNS-related Adverse Events.

  Up to 9 weeks

• Percentage of Grade 3 or Higher NPNS-related Adverse Events.

  Up to 9 weeks

Study Arms (1)

Noninvasive Peripheral Nerve Stimulation (NPNS)

EXPERIMENTAL

NPNS device programmed to deliver active stimulation.

Device: Noninvasive Peripheral Nerve Stimulation (NPNS)

Interventions

Noninvasive Peripheral Nerve Stimulation (NPNS) DEVICE

NPNS device programmed to deliver active stimulation.

Noninvasive Peripheral Nerve Stimulation (NPNS)

Eligibility Criteria

• Age: 18 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 currently taking a stable dose of at least one prescription opioid for RLS, where the total opioid dose is less than or equal to 60mg morphine milligram equivalents (MME) per day.
• RLS symptoms are most significant in the subject's legs and/or feet.
• 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 18 to 89 years of age (inclusive) 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.
• Subject has been taking a stable dose and schedule of prescription opioids for RLS for at least 3 months prior to enrollment.

You may not qualify if:

• Subject has RLS that is known to be caused by another diagnosed condition (i.e. secondary RLS).
• Subject was misdiagnosed with RLS, as determined by the investigator (e.g. actual diagnosis of Periodic Leg Movement Disorder (PLMD), arthritis, leg spasms or neuropathy without comorbid RLS).
• Subject has primary sleep disorder other than RLS that significantly interferes with sleep at the present time (e.g. unmanaged sleep apnea or general insomnia).
• Subject has been diagnosed with one of the following conditions at any time: Epilepsy or other seizure disorder, Severe movement disorder symptoms (Parkinson's disease, Huntington's disease, dyskinesia, dystonia), Deep Vein Thrombosis, Multiple sclerosis
• Subject has an active diagnosis of one of the following conditions: Acute or chronic infection other than viral upper respiratory tract infections, Stage 4-5 chronic kidney disease or renal failure, Iron-deficient anemia, Severe edema affecting lower legs
• Subject has any of the following at the location of device application: Acute injury, Cellulitis, Open sores
• Subject has 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 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.
• During NPNS calibration, subject has a sensation threshold above the upper-cutoff value (e.g. 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 significantly changed dose or schedule of a medication that may impact RLS symptoms within the 30 days prior to enrollment, as judged by the investigator (e.g. antidepressants, sleep medications, sedative antihistamines).
• 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 another medical condition that may affect validity of the study as determined by the investigator.
• Subject is unable or unwilling to comply with study requirements.
• Moderate or severe cognitive disorder or mental illness.

Sponsors & Collaborators

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

Study Sites (2)

Mark J Buchfuhrer private practice

Downey, California, 90241, United States

Location

Ohio Sleep Medicine Institute

Dublin, Ohio, 43017, United States

Location

Related Publications (1)

• Buchfuhrer MJ, Roy A, Rodriguez S, Charlesworth JD. Adjunctive tonic motor activation enables opioid reduction for refractory restless legs syndrome: a prospective, open-label, single-arm clinical trial. BMC Neurol. 2023 Nov 21;23(1):415. doi: 10.1186/s12883-023-03462-6.

  PMID: 37990163 DERIVED

MeSH Terms

Conditions

Restless Legs Syndrome

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Jonathan Charlesworth, PhD
• Organization: Noctrix Health, Inc.

jcharlesworth@noctrixhealth.com

804-683-4279

Study Officials

• Jonathan D Charlesworth, PhD

  Noctrix Health, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2021
• First Posted: January 6, 2021
• Study Start: April 6, 2021
• Primary Completion: February 27, 2023
• Study Completion: March 28, 2023
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)