Active neurostimulation for Restless Legs Syndrome

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Restless Legs SyndromeNTX100 Neuromodulation System - Active - Device
Eligibility
22 - 89
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test a new non-invasive treatment for restless legs syndrome (RLS). The study will compare the new treatment to a sham (fake) treatment, and will test how well the treatment works and how well tolerated it is.

Eligible Conditions
  • Restless Legs Syndrome

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

3 Primary · 9 Secondary · Reporting Duration: 90 minutes

1 night
Polysomnography-Based Percentage of REM Sleep
Polysomnography-Based Percentage of Stage 2 Sleep
Polysomnography-Based Percentage of Stage 3 Sleep
Polysomnography-Based Sleep Efficiency
Polysomnography-Based Sleep Onset Latency
Polysomnography-Based Total Sleep Time
1 week
Actigraphy-Based Sleep Efficiency
Actigraphy-Based Total Sleep Time
International Restless Legs Syndrome Study Group Rating Scale (IRLS) score
Patient Global Impressions of Improvement Responder Rate
2 weeks
Actigraphy-Based Sleep Onset Latency
Frequency of Device Usage
Grade 2 or higher device-related adverse events
Grade 3 or higher device-related adverse events
Medical Outcomes Study Sleep Problems Index I (MOS-I) score
Medical Outcomes Study Sleep Problems Index II (MOS-II) score
Tolerability based on Withdrawal Rate
30 minutes
Numerical Rating Scale in Suggested Immobilization Test at 30 minutes
60 minutes
Numerical Rating Scale in Suggested Immobilization Test at 60 minutes
90 minutes
Numerical Rating Scale in Suggested Immobilization Test at 90 minutes

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Active neurostimulation
1 of 2
Sham neurostimulation
1 of 2

Active Control

Non-Treatment Group

40 Total Participants · 2 Treatment Groups

Primary Treatment: Active neurostimulation · Has Placebo Group · N/A

Active neurostimulation
Device
ActiveComparator Group · 1 Intervention: NTX100 Neuromodulation System - Active · Intervention Types: Device
Sham neurostimulation
Device
ShamComparator Group · 1 Intervention: NTX100 Neuromodulation System - Sham · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 90 minutes

Who is running the clinical trial?

Noctrix Health, Inc.Lead Sponsor
4 Previous Clinical Trials
307 Total Patients Enrolled
4 Trials studying Restless Legs Syndrome
307 Patients Enrolled for Restless Legs Syndrome
National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,260 Previous Clinical Trials
454,485 Total Patients Enrolled
4 Trials studying Restless Legs Syndrome
171 Patients Enrolled for Restless Legs Syndrome
Jonathan D Charlesworth, PhDStudy DirectorNoctrix Health, Inc.
4 Previous Clinical Trials
307 Total Patients Enrolled
4 Trials studying Restless Legs Syndrome
307 Patients Enrolled for Restless Legs Syndrome

Eligibility Criteria

Age 22 - 89 · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have received a medical diagnosis of primary restless legs syndrome (RLS).
You are either medication-naïve or medication-refractory.
You have moderate-severe RLS symptoms as defined by a score of 15 or greater points on the IRLS (International Restless Legs Syndrome Study Group Rating Scale) over the week prior to study entry.
You have RLS symptoms that interfere with sleep on at least 3 nights per week during the month prior to study entry.
Symptoms are most significant in the subject's lower legs and/or feet.
You agree to not make major lifestyle changes during the study that would significantly affect bedtime, such as major changes to diet, exercise, or career.
You possess 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.