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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
RLS symptoms interfered with sleep on at least 3 nights per week during the month prior to study entry.
Subject is either medication-naïve or medication-refractory.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 minutes
Awards & highlights

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

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You experienced restless legs syndrome symptoms that disturbed your sleep on at least 3 nights per week in the month before joining the study.
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You have either never taken the medication before or have not responded well to it.
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You have been diagnosed with primary restless legs syndrome.
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Criterion: The subject's restless legs syndrome symptoms are strongest in their lower legs and/or feet.
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Your restless legs symptoms are worse after 6pm.
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You are experiencing moderate to severe symptoms of Restless Legs Syndrome, as measured by a score of 15 or higher on a specific scale.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Actigraphy-Based Sleep Efficiency
Actigraphy-Based Total Sleep Time
Tolerability based on Withdrawal Rate
Secondary outcome measures
Frequency of Device Usage
Grade 2 or higher device-related adverse events
Grade 3 or higher device-related adverse events
+6 more
Other outcome measures
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
623 Total Patients Enrolled
5 Trials studying Restless Legs Syndrome
623 Patients Enrolled for Restless Legs Syndrome
National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,335 Previous Clinical Trials
648,473 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
298 Total Patients Enrolled
4 Trials studying Restless Legs Syndrome
298 Patients Enrolled for Restless Legs Syndrome

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many enrollees are participating in this experimental research?

"Yes, information on clinicaltrials.gov attests to the fact that this trial is currently enrolling participants. The venture was first posted on March 8th 2022 and has since been updated as recently as April 26th of the same year; it requires 40 patients across 2 separate hospitals or clinics."

Answered by AI

May I partake in this clinical experiment?

"This clinical trial is actively seeking 40 people aged between 22 and 89 with a diagnosed case of restless legs syndrome. Eligibility criteria includes a score of 15+ on the International Restless Legs Syndrome Study Group Rating Scale in the week prior to study entry, moderate-severe RLS symptoms that interfered with sleep at least 3 nights/week during the month before entering the trial, primary RLS confined primarily to lower limbs/feet, agreement not to alter any medications known to influence RSL symptoms or make major lifestyle changes throughout the duration of this research project; as well as having access to appropriate electronic equipment for completing questionnaires and responding promptly"

Answered by AI

Are applicants below the age of sixty eligible to join this experiment?

"This clinical trial seeks out individuals between the ages of 22 and 89."

Answered by AI

Is this experiment actively soliciting participants?

"Evidenced by clinicaltrials.gov, this research endeavour is actively recruiting for participants and was initially posted on March 8th 2022; it has since been revised as of April 26th 2022."

Answered by AI

What is the central purpose of this experiment?

"This two week study is designed to measure Actigraphy-Based Sleep Efficiency. Additionally, it will assess Polysomnography-Based Sleep Efficiency, International Restless Legs Syndrome Study Group Rating Scale scores and Patient Global Impressions of Improvement Responder Rate."

Answered by AI
~19 spots leftby Mar 2025