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
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
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
103
Active Noninvasive peripheral nerve stimulation device programmed to active mode
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
Number of Subjects for Which the Clinician Reported "Much Improved" or "Very Much Improved" on the Clinical Global Impressions-Improvement (CGI-I) Scale in Treatment Group (Arm 1) Relative to Baseline.
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. The outcomes were also evaluated as Treatment Group (Arm 1) at 24 weeks related to Control Group (Arm 2) at 24 weeks. The primary outcome, however, is the measure relative to baseline.
Time frame: Week 24
Number of Subjects That Report "Much Improved" or "Very Much Improved" on the Patient Global Impressions-Improvement (PGI-I) Scale in the Treatment Group (Arm 1) Relative to Baseline.
Responder rate is defined as the proportion of responses "Much Improved" or "Very Much Improved" on the Patient Global Impressions-Improvement (PGI-I) Scale in the Treatment Group (Arm 1) Relative to Baseline. Note that the Responder Rate was be calculated relative to baseline for the endpoint but was also be calculated relative to the value for the control group at Week 24.
Time frame: Week 24
Mean Change From Baseline in International Restless Legs Syndrome Study Group Rating Scale (IRLS) Score in Arm 1
IRLS is a participant-rated questionnaire that rates RLS severity from 0-40, where 40 is the most severe. Note that the IRLS score was calculated relative to baseline for the endpoint but was also be calculated relative to the value for the control group at Week 24.
Time frame: Week 24
Mean Change From Baseline in Medical Outcomes Study Sleep Problems Index II (MOS-II) Score in Arm 1
MOS-II is a subscale of the participant-rated MOS questionnaire that measures subjective sleep quality. The MOS-I (6-items) and MOS-II (9-items) are the two validated subscales of the 12-item MOS Sleep Scale. Both are scored from 0 to 100, where 100 corresponds to the worst possible sleep problems and 0 corresponds to no sleep problems. See https://labs.dgsom.ucla.edu/hays/files/view/docs/surveys/sleep/sleepman-112603.pdf for more information. Note that the mean MOS-II score was calculated relative to baseline for the endpoint but was also be calculated relative to the value for the control group at Week 24.
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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
Time frame: Week 24
Mean Change From Baseline in Medical Outcomes Study Sleep Problems Index I (MOS-I) Score in Arm 1
MOS-I is a subscale of the participant-rated MOS questionnaire that measures subjective sleep quality. The MOS-I (6-items) and MOS-II (9-items) are the two validated subscales of the 12-item MOS Sleep Scale. Both are scored from 0 to 100, where 100 corresponds to the worst possible sleep problems and 0 corresponds to no sleep problems. See https://labs.dgsom.ucla.edu/hays/files/view/docs/surveys/sleep/sleepman-112603.pdf for more information. Note that the outcome is measured relative to baseline but also relative to the Arm 2 (control group) at 24 weeks.
Time frame: Week 24
Days Per Week of RLS Symptoms Based on Question #7 in the International Restless Legs Syndrome Study Group Rating Scale (IRLS) Score in Arm 1
The International Restless Legs Syndrome (IRLS) Question #7 is a participant-rated question that measures the frequency of RLS symptoms in terms of days per week.
Time frame: Week 24