Extension Study Evaluating NTX100 Neuromodulation System for Medication-Refractory Primary RLS
Study Details
Study Description
Brief 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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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
[Not Yet Recruiting, Contingent on factors including enrollment in Arm 1] Arm 3 (Delayed Extension): 24-week open-label NPNS followed by 8-weeks of no treatment, fixed delay after completion of the RESTFUL Study
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Arm 1 - Direct Roll-Over Extension 24-wks of Active neurostimulation - Noninvasive peripheral nerve stimulation device programmed to deliver active stimulation; followed by 8-wks of No Intervention |
Device: NTX100 Neuromodulation System
Active Noninvasive peripheral nerve stimulation device programmed to active mode
|
| No Intervention: Arm 2 - Control Group 24-wks of No Intervention |
|
| Active Comparator: [Not Yet Recruiting] Arm 3 - Delayed Extension 24-wks of Active neurostimulation - Noninvasive peripheral nerve stimulation device programmed to deliver active stimulation; followed by 8-wks of No Intervention |
Device: NTX100 Neuromodulation System
Active Noninvasive peripheral nerve stimulation device programmed to active mode
|
Outcome Measures
Primary Outcome Measures
- Responder rate on Clinical Global Impressions-Improvement (CGI-I) scale in Arm 1 [Week 24 of Arm 1 relative to entry to the RESTFUL study]
Responder rate is defined as the proportion of responses of "Much Improved" or "Very Much Improved" relative to baseline on the investigator-rated 7-point CGI-I scale.
Secondary Outcome Measures
- Responder rate on Patient Global Impressions-Improvement (PGI-I) scale in Arm 1 [Week 24 of Arm 1 relative to entry to the RESTFUL study]
Responder rate is defined as the proportion of responses of "Much Improved" or "Very Much Improved" relative to baseline on the participant-rated 7-point PGI-I scale.
- Mean International Restless Legs Syndrome Study Group Rating Scale (IRLS) score in Arm 1 [Week 24 of Arm 1 relative to entry to the RESTFUL study]
IRLS is a participant-rated questionnaire that rates RLS severity from 0-40, where 40 is the most severe.
- Mean Medical Outcomes Study Sleep Problems Index II (MOS-II) score in Arm 1 [Week 24 of Arm 1 relative to entry to the RESTFUL study]
MOS-II is a subscale of the participant-rated MOS questionnaire that measures subjective sleep quality.
- Mean Medical Outcomes Study Sleep Problems Index I (MOS-I) score in Arm 1 [Week 24 of Arm 1 relative to entry to the RESTFUL study]
MOS-I is a subscale of the participant-rated MOS questionnaire that measures subjective sleep quality.
- Frequency of RLS symptoms based on Question #7 in the International Restless Legs Syndrome Study Group Rating Scale (IRLS) score in Arm 1 [Week 24 of Arm 1 relative to entry to the RESTFUL study]
IRLS Question #7 is a participant-rated question that measures frequency of RLS symptoms in terms of days per week.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Subject previously completed the RESTFUL Study (NCT04874155).
-
[applicable to Arms 1 and 3 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.
-
Subject has signed a valid, IRB-approved informed consent form, can understand the requirements of the study and instructions for device usage, and can converse in English.
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[applicable to Arm 3 only] Subject has moderate-severe RLS symptoms as defined by a score of 15 or greater points on IRLS (International Restless Legs Syndrome Study Group Rating Scale [12]) over the week prior to study entry.
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[applicable to Arm 3 only] Subject has RLS symptoms 2 or more nights per week during the week prior to study entry as defined by a score of 2, 3, or 4 on IRLS question #7.
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[applicable to Arm 3 only] RLS symptoms are most significant in the subject's lower legs and/or feet.
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[applicable to Arm 3 only] RLS symptoms are most significant at bedtime, after bedtime, and/or in the 2 hours before bedtime.
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[applicable to Arm 3 only] RLS symptoms between 10am and 6pm are not severe.
-
[applicable to Arm 3 only] Subject possesses the necessary equipment, internet/phone accessibility, and communication ability to complete electronic questionnaires and respond to electronic communications and phone calls from the research staff throughout the in-home portion of the study.
Exclusion Criteria:
-
[applicable to Arms 1 and 3 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.
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[applicable to Arms 1 and 3 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]
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A malignancy within the past 5 years (not including basal or squamous cell skin cancer)
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Stage 4-5 chronic kidney disease or renal failure
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Severe movement disorder symptoms (Parkinson's disease, Huntington's disease, dyskinesia, dystonia)
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Deep vein thrombosis
-
Multiple sclerosis
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Subject has moderate or severe cognitive disorder or mental illness.
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[applicable to Arms 1 and 3 only] Subject has known allergy to device materials, electrode gel, polyurethane foam, or lycra (or severe previous reaction to medical adhesives or bandages).
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[applicable to Arms 1 and 3 only] Subject has severe edema affecting lower legs.
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[applicable to Arms 1 and 3 only] Subject has any of the following at or near the location of device application.
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Acute injury
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Cellulitis
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Open sores
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Other skin condition
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[applicable to Arms 1 and 3 only] Subject is on dialysis or anticipated to start dialysis while participating in the study.
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[applicable to Arms 1 and 3 only] Subject has received another investigational device or drug within 30 days before study entry, is planning to receive another investigational device or drug during the study, or is planning to change RLS medications during the study.
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Subject is unable or unwilling to comply with study requirements.
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[applicable to Arms 1 and 3 only] Subject is pregnant or trying to become pregnant.
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Subject has a medical condition not listed above that may affect validity of the study as determined by the investigator.
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[applicable to Arms 1 and 3 only] Subject has a medical condition not listed above that may put the subject at risk as determined by the investigator.
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Subject was unwilling or unable to follow instructions in the RESTFUL Study, including missing 2 or more follow-up evaluations.
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[applicable to Arms 1 and 3 only] Subject failed to properly operate the investigational devices during Weeks 5-8 of the RESTFUL Study.
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[applicable to Arms 1 and 3 only] Subject experienced a significantly higher than expected rate of device malfunctions in the RESTFUL Study, such that the malfunctions appeared to be directly related to the subject's pattern of use.
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[applicable to Arm 3 only] Subject is taking an unstable or inconsistent dose or schedule of medication that is likely to impact RLS symptoms, such as antidepressants, sleep medications, or sedative antihistamines or has changed dosage within the past 30 days.
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[applicable to Arm 3 only] Subject has changed dose and schedule of RLS medications within the month prior to study entry or is otherwise on an inconsistent dose or schedule of RLS medications.
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[applicable to Arm 3 only] Subject has a primary sleep disorder other than RLS that significantly interferes with sleep at the present time (e.g. obstructive sleep apnea stably controlled via CPAP would not be an exclusion).
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[applicable to Arm 3 only] Subject has severe peripheral neuropathy affecting the lower legs and/or subject has neuropathy and is unable to clearly distinguish between symptoms of neuropathy and symptoms of RLS.
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[applicable to Arm 3 only] Subject reports that bedtime is typically outside of 9pm-3am or reports that bedtime regularly varies by more than 4 hours, such as due to shift work.
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[applicable to Arm 3 only] On nights with no RLS symptoms (if any), subject reports typical sleep onset latency of >60min.
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[applicable to Arm 3 only] Subject has undergone a major surgery (excluding dental work) in the 30 days prior to study entry.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | California Center for Sleep Disorders | San Leandro | California | United States | 94578 |
| 2 | Delta Waves, Inc. | Colorado Springs | Colorado | United States | 95125 |
| 3 | Neurotrials Research | Atlanta | Georgia | United States | 30328 |
| 4 | Clayton Sleep Institute | Saint Louis | Missouri | United States | 63123 |
| 5 | Ohio Sleep Medicine Institute | Dublin | Ohio | United States | 43017 |
| 6 | Bogan Sleep Consultants, LLC | Columbia | South Carolina | United States | 29201 |
| 7 | FutureSearch Trials of Neurology | Austin | Texas | United States | 78731 |
Sponsors and Collaborators
- Noctrix Health, Inc.
Investigators
- Study Director: Jonathan D Charlesworth, PhD, Noctrix Health, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CT-05