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Neuromodulation

Peripheral Nerve Stimulation for Restless Legs Syndrome

N/A
Waitlist Available
Research Sponsored by Noctrix Health, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 minutes

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 minutes
This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 minutes for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Actigraphy-Based Sleep Efficiency
Actigraphy-Based Total Sleep Time
Tolerability based on Withdrawal Rate
Secondary study objectives
Frequency of Device Usage
Grade 2 or higher device-related adverse events
Grade 3 or higher device-related adverse events
+6 more
Other study objectives
Actigraphy-Based Sleep Onset Latency
Medical Outcomes Study Sleep Problems Index I (MOS-I) score
Medical Outcomes Study Sleep Problems Index II (MOS-II) score
+5 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Active neurostimulationActive Control1 Intervention
Noninvasive peripheral nerve stimulation device programmed to deliver active stimulation
Group II: Sham neurostimulationPlacebo Group1 Intervention
Noninvasive peripheral nerve stimulation device programmed to deliver non-therapeutic (sham) stimulation

Find a Location

Who is running the clinical trial?

Noctrix Health, Inc.Lead Sponsor
5 Previous Clinical Trials
625 Total Patients Enrolled
5 Trials studying Restless Legs Syndrome
625 Patients Enrolled for Restless Legs Syndrome
National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,380 Previous Clinical Trials
652,123 Total Patients Enrolled
4 Trials studying Restless Legs Syndrome
162 Patients Enrolled for Restless Legs Syndrome
Jonathan D Charlesworth, PhDStudy DirectorNoctrix Health, Inc.
4 Previous Clinical Trials
300 Total Patients Enrolled
4 Trials studying Restless Legs Syndrome
300 Patients Enrolled for Restless Legs Syndrome
~16 spots leftby Nov 2025
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