MedTrace Logo

Noninvasive Peripheral Nerve Stimulation for Restless Legs Syndrome

NCT04700683 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2021-01-08

No results posted yet for this study

Summary

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.

Conditions

  • Restless Legs Syndrome

Interventions

DEVICE

Noctrix Health NPNS device v1.0 - Active

Wearable device programmed to deliver electrical stimulation to peripheral nerves of the lower limbs.

DEVICE

Noctrix Health NPNS device v1.0 - Sham

Wearable device programmed to deliver sham stimulation.

Sponsors & Collaborators

  • Noctrix Health, Inc.

    lead INDUSTRY

Principal Investigators

  • Jonathan D Charlesworth, PhD · Noctrix Health, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-14
Primary Completion
2020-03-01
Completion
2020-03-01
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04700683 on ClinicalTrials.gov