MedTrace Logo

Cranial Electrotherapy for Military Beneficiaries With Restless Legs Syndrome

NCT02419014 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2025-02-10

No results posted yet for this study

Summary

The purpose of this study is to assess the feasibility and effectiveness of Cranial Electrical Stimulation (CES) therapy in treating symptoms of Restless Legs Syndrome (RLS). Participants will be randomly assigned to one of three groups, a usual care (control group), an active CES device group and a sham (inactive) CES device group. Those who are enrolled in one of the device groups will not know which type of device they have (blinding). Those enrolled in the usual care group and sham groups will ultimately have the option to use the active device after they complete the study. Study length for participants is 8 weeks.

Conditions

  • Restless Legs Syndrome

Interventions

DEVICE

Active CES Device Alpha-Stim®

The Alpha-Stim® device is a Class II FDA-approved device for the delivery of cranial electrotherapy using microcurrents that are delivered via two electrodes worn on the earlobes. Active CES devices will be pre-programmed by the manufacturer to deliver a bipolar, asymmetric rectangular waveform at a current of 100 µa, a level that is generally undetectable by the wearer of the device. At these settings, the manufacturer recommends a treatment duration of 60 minutes. Participants will not be able to alter the settings in any way.

DEVICE

Sham Device

The inactive (sham) devices look identical to the active device but are inactivated by the manufacturer so as not to deliver any electrical current.

Sponsors & Collaborators

  • University of Virginia

    collaborator OTHER

  • Tripler Army Medical Center

    lead FED

Principal Investigators

  • Terri L Yost, PhD · Walter Reed National Military Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2017-02-28
Completion
2017-02-28

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 NCT02419014 on ClinicalTrials.gov