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Extension Study Evaluating NTX100 Neuromodulation System for Medication-Refractory Primary RLS

Open-label Extension Study to Evaluate Longer-Duration Response to the NTX100 Neuromodulation System for Patients With Medication-Refractory Primary Restless Legs Syndrome (RLS)

NCT05196828•Noctrix Health, Inc.

View on ClinicalTrials.gov

Summary

Multi-center, prospective open-label extension study of noninvasive peripheral nerve stimulation (NPNS) with the NTX100 Neuromodulation System for patients with medication-refractory moderate- severe primary RLS

Detailed Description

This is an extension study only inviting subjects who have previously completed the RESTFUL Study (NCT04874155). Each study subject is enrolled into one of the following Arms: Arm 1 (Direct Roll-Over Extension): 24-week open-label NPNS followed by 8-weeks of no treatment, no delay after completion of the RESTFUL Study Arm 2 (Control Group): 24-weeks of no treatment

Eligibility

Age

22 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Subject previously completed the RESTFUL Study (NCT04874155).
•2. Subject has signed a valid, Institutional Review Board-approved informed consent form, can understand the requirements of the study and instructions for device usage, and can converse in English.
•3. \[applicable to Arm 1 only\] Subject agrees to not change dosage or schedule of any medications that are known to impact RLS symptoms during the study, including RLS medications, antidepressants, sleep medications, or sedative antihistamines.

Exclusion Criteria

•1. \[applicable to Arm 1 only\] Subject has active medical device implant anywhere in the body (including but not limited to pacemakers, spinal cord stimulators, deep brain stimulators) or metal implant at the site of study device electrode application.
•2. \[applicable to Arm 1 only\] Subject has been diagnosed with one of the following conditions:
•* Epilepsy or other seizure disorder Current, active or acute or chronic infection other than common cold \[and except for acute infections with mild symptoms\]
•* A malignancy within the past 5 years (not including basal or squamous cell skin cancer)
•* Stage 4-5 chronic kidney disease or renal failure
•* Severe movement disorder symptoms (Parkinson's disease, Huntington's disease, dyskinesia, dystonia)
•* Deep vein thrombosis
•* Multiple sclerosis
•3. Subject has moderate or severe cognitive disorder or mental illness.
•4. \[applicable to Arm 1 only\] Subject has known allergy to device materials, electrode gel, polyurethane foam, or lycra (or severe previous reaction to medical adhesives or bandages).
+15 more criteria

Locations (7)

California Center for Sleep Disorders

San Leandro, California, United States

Delta Waves, Inc.

Colorado Springs, Colorado, United States

Neurotrials Research

Atlanta, Georgia, United States

Clayton Sleep Institute

St Louis, Missouri, United States

Ohio Sleep Medicine Institute

Dublin, Ohio, United States

Bogan Sleep Consultants, LLC

Columbia, South Carolina, United States

FutureSearch Trials of Neurology

Austin, Texas, United States

Key Dates

Start Date

December 20, 2021

Primary Completion Date

September 27, 2022

Completion Date

November 18, 2022

Last Updated

September 19, 2024

Enrollment

103

ACTUAL participants

Conditions

Restless Legs Syndrome

Interventions

NTX100 Neuromodulation System

DEVICE

Functional Connectivity of the Interoceptive Network in RLS

NCT07001891

Restless Legs Syndrome

View study

RECRUITINGNA

The Application of Wide Pulse High Frequency Neuromuscular Electrical Stimulation in Disorders Associated With Motoneuron Hyperexcitability

NCT05908214

StrokeCramp+2 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 19, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Extension Study Evaluating NTX100 Neuromodulation System for Medication-Refractory Primary RLS

Inclusion Criteria

Exclusion Criteria

Functional Connectivity of the Interoceptive Network in RLS

The Application of Wide Pulse High Frequency Neuromuscular Electrical Stimulation in Disorders Associated With Motoneuron Hyperexcitability

Quality Improvement and Practice Based Research in Neurology Using the EMR

A Post-Market Study for Long-Term Effectiveness and Safety of the NTX100 for RLS

Adverse Long-term Consequences of Sleep Disordered Breathing: The Ottawa Hospital (TOH) Sleep Database

Impact of Iron Supplementation Treatment on Brain Iron Concentrations