Prospective multi-site randomized sham-controlled crossover feasibility study evaluating tolerability and efficacy of noninvasive peripheral nerve stimulation (NPNS) for patients with moderate-severe primary Restless Legs Syndrome (RLS). Response to NPNS investigational device was compared to sham control in a 2x2 crossover design such that subjects were assigned to receive 2 weeks of NPNS and 2 weeks of sham, in randomized order.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
SINGLE
Enrollment
43
Wearable device programmed to deliver electrical stimulation to peripheral nerves of the lower limbs.
Wearable device programmed to deliver sham stimulation.
Mark J Buchfuhrer private practice
Downey, California, United States
SRI International Human Sleep Research Lab
Menlo Park, California, United States
Sleep Medicine Specialists of California
San Ramon, California, United States
Evaluate the clinical tolerability, usability, and patient response for the prototype device, with the intention of improving overall device performance.
Subject satisfaction and usability questionnaire
Time frame: Weeks 1-2 of each intervention
Change from baseline in International Restless Legs Syndrome Study Group Rating Scale (IRLS) score at week 2
International Restless Legs Syndrome Study Group Rating Scale is a participant-rated questionnaire that rates RLS severity from 0-40, where 40 is the most severe.
Time frame: Week 2 of each intervention compared to week prior to study entry
Change to Summary NRS score of RLS symptom severity
Participant rating of average RLS symptom severity from 0-10 on a Numerical Rating Scale (NRS) scale, where 10 is the most severe. Participants complete a single Summary NRS scale at the end of each 2-week intervention, rating the average RLS symptoms before, during, and after device usage.
Time frame: Weeks 1-2 of each intervention
Change to Daily NRS score of RLS symptom severity
Participant rating of average RLS symptom severity from 0-10 on a Numerical Rating Scale (NRS) scale, where 10 is the most severe. Participants complete the Daily NRS scale each day during each 2-week intervention, rating the RLS symptoms before, during, and after the previous night of device use.
Time frame: Weeks 1-2 of each intervention
Responder rate on CGI-I scale at week 2 relative to baseline
Responder rate is defined as the proportion of responses of "Much Improved" or "Very Much Improved" relative to baseline on the 7-point participated-rated Clinical Global Impressions-Improvement (CGI-I) scale.
Time frame: Week 2 of each intervention compared to week prior to study entry
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.