Trials / Completed
CompletedNCT04700683
Noninvasive Peripheral Nerve Stimulation for Restless Legs Syndrome
Chronic Efficacy and Usability of Transcutaneous Electrical Nerve Stimulation in Subjects With Restless Leg Syndrome (RLS)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 43 (actual)
- Sponsor
- Noctrix Health, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2019-07-14
- Primary completion
- 2020-03-01
- Completion
- 2020-03-01
- First posted
- 2021-01-08
- Last updated
- 2021-01-08
Locations
3 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04700683. Inclusion in this directory is not an endorsement.