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Behavioural Intervention

Noninvasive Peripheral Nerve Stimulation (NPNS) 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 1 week assessment period for step-down #2 compared to 1 week baseline period
Awards & highlights

Study Summary

This trial is testing a new way to help people with RLS who are taking opioids by reducing their medication while using noninvasive peripheral nerve stimulation.

Eligible Conditions
  • Restless Legs Syndrome

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 week assessment period for step-down #2 compared to 1 week baseline period
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 week assessment period for step-down #2 compared to 1 week baseline period for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Opioid reduction tolerability rate during step-down #1 as measured by Clinical Global Impression - Improvement (CGI-I) scale
Secondary outcome measures
Change from baseline in IRLS score during step-down #2
Change from baseline in International Restless Legs Syndrome Study Group Rating Scale (IRLS) score during step-down #1
Maximal tolerated reduction in opioid dose
+1 more
Other outcome measures
Frequency of Grade 2 or higher NPNS-related adverse events.
Frequency of Grade 3 or higher NPNS-related adverse events.
NPNS compliance during step-down #1
+2 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Noninvasive Peripheral Nerve Stimulation (NPNS)Experimental Treatment1 Intervention
NPNS device programmed to deliver active stimulation.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Noninvasive Peripheral Nerve Stimulation (NPNS)
2021
N/A
~30

Find a Location

Who is running the clinical trial?

Noctrix Health, Inc.Lead Sponsor
5 Previous Clinical Trials
660 Total Patients Enrolled
5 Trials studying Restless Legs Syndrome
660 Patients Enrolled for Restless Legs Syndrome
National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,339 Previous Clinical Trials
649,369 Total Patients Enrolled
4 Trials studying Restless Legs Syndrome
199 Patients Enrolled for Restless Legs Syndrome
Jonathan D Charlesworth, PhDStudy DirectorNoctrix Health, Inc.
4 Previous Clinical Trials
335 Total Patients Enrolled
4 Trials studying Restless Legs Syndrome
335 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 participants are taking part in this experiment?

"Affirmative. According to the information hosted on clinicaltrials.gov, enrollment for this trial is ongoing since its initial posting date of April 6th 2021, with a last update made on June 15th 2022. This experiment requires 30 participants from two sites."

Answered by AI

Is this scientific trial still welcoming new participants?

"Affirmative. The details posted on clinicaltrials.gov show that the study, which was first announced in April of 2021, is actively recruiting patients to participate. A total of 30 participants must be enrolled from 2 different medical facilities."

Answered by AI

What tangible objectives are being sought after through this medical research?

"This trial's primary outcome, which will be evaluated over a timespan of one week for step-down #1 versus the baseline period, is assessing opioid reduction tolerability rate as measured by Clinical Global Impression - Improvement (CGI-I) scale. As secondary outcomes, there are also measurements of opioid reduction during phase 2 and modifications in International Restless Legs Syndrome Study Group Rating Scale (IRLS) scores between both phases."

Answered by AI

Is there an age cutoff for participation in this scientific exploration?

"This study has specified that the lower and upper age limits for enrollment are 18 and 89, respectively."

Answered by AI

What prerequisites must prospective participants meet to join this clinical research?

"This examination seeks 30 restless legs syndrome sufferers that range from 18 to 89 years of age. To be considered, applicants must meet the following conditions: RLS symptoms predominantly impact their lower body; they have been officially diagnosed with primary RLS; they possess the necessary technological capabilities for online questionnaires and telephone conversations throughout the in-home element of this study; and have taken a consistent dosage/schedule of opioid medications for at least 3 months prior joining this trial."

Answered by AI

Who else is applying?

What state do they live in?
Ohio
Nevada
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
Ohio Sleep Medicine Institute
How many prior treatments have patients received?
1

Why did patients apply to this trial?

I take 1 mg of pramipexol daily but still have moderate symptoms of restless legs and arms.
PatientReceived 2+ prior treatments

How responsive is this trial?

Most responsive sites:
  1. Ohio Sleep Medicine Institute: < 48 hours
Typically responds via
Phone Call
Email
Average response time
  • < 2 Days
~5 spots leftby Apr 2025