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Neuromodulation

Arm 1 - Direct Roll-Over Extension 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 week 24 of arm 1 relative to entry to the restful study
Awards & highlights

Study Summary

This trial is studying a non-invasive nerve stimulator to see if it helps people with moderate to severe RLS who haven't responded to medication.

Eligible Conditions
  • Restless Legs Syndrome

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 24 of arm 1 relative to entry to the restful study
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 24 of arm 1 relative to entry to the restful study for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Responder rate on Clinical Global Impressions-Improvement (CGI-I) scale in Arm 1
Secondary outcome measures
Frequency of RLS symptoms based on Question #7 in the International Restless Legs Syndrome Study Group Rating Scale (IRLS) score in Arm 1
Mean International Restless Legs Syndrome Study Group Rating Scale (IRLS) score in Arm 1
Mean Medical Outcomes Study Sleep Problems Index I (MOS-I) score in Arm 1
+2 more

Trial Design

2Treatment groups
Active Control
Group I: Arm 1 - Direct Roll-Over ExtensionActive Control1 Intervention
24-wks of Active neurostimulation - Noninvasive peripheral nerve stimulation device programmed to deliver active stimulation; followed by 8-wks of No Intervention
Group II: Arm 2 - Control GroupActive Control1 Intervention
24-wks of No Intervention

Find a Location

Who is running the clinical trial?

Noctrix Health, Inc.Lead Sponsor
5 Previous Clinical Trials
580 Total Patients Enrolled
5 Trials studying Restless Legs Syndrome
580 Patients Enrolled for Restless Legs Syndrome
Jonathan D Charlesworth, PhDStudy DirectorNoctrix Health, Inc.
4 Previous Clinical Trials
255 Total Patients Enrolled
4 Trials studying Restless Legs Syndrome
255 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.

Can individuals aged 55 and above partake in this trial?

"Consistent with the eligibility criteria, individuals aged 22 and above, but not exceeding 80 years old are able to register for this trial."

Answered by AI

Is this research project currently enrolling participants?

"Unfortunately, this medical study has reached the point where it is no longer accepting applicants. The trial was initially made public on December 20th 2021 and last edited on August 19th 2022; however, there are 1437 other studies actively recruiting participants presently."

Answered by AI

Is there a strong presence of this trial in the city?

"The study is being conducted at 10 sites, with FutureSearch Trials of Neurology in Austin, Texas; Bogan Sleep Consultants, LLC located in Columbia, South carolina; and Delta Waves Inc. situated in Colorado Springs all taking part."

Answered by AI

Who meets the eligibility requirements to partake in this medical experiment?

"This clinical trial is enrolling 101 people that have been diagnosed with restless leg syndrome, aged 22 to 80."

Answered by AI

Who else is applying?

What state do they live in?
Ohio
How old are they?
18 - 65
What site did they apply to?
Ohio Sleep Medicine Institute
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
2

Why did patients apply to this trial?

I have tried 2 medications and I am on a high dose of pramipexol now with moderate benefits but significant side effects.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Extension Study Evaluating NTX100 Neuromodulation System for Medication-Refractory Primary RLS
2021. "Extension Study Evaluating NTX100 Neuromodulation System for Medication-Refractory Primary RLS". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05196828.
~30 spots leftby Apr 2025
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