Cranial Electrotherapy for Military Beneficiaries With Restless Legs Syndrome

NCT ID: NCT02419014

Last Updated: 2025-02-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2017-02-28

Brief 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.

Detailed Description

Restless Legs Syndrome (RLS) is a chronic neurologic disease that causes painful and distressing dysesthesias in the lower extremities at night affecting sleep quality and greatly influencing general overall health. Leading theories as to the cause of RLS symptoms point to a deficiency of central nervous system dopamine levels. Cranial Electrical Stimulation (CES) is a therapy that has been shown to affect activity in dopaminergic regions of the brain. The purpose of this study is to assess the feasibility and efficacy of CES therapy in the management of symptoms of RLS. The overall study design will use mixed methods. The specific aims for the experimental analysis are to (1) determine the feasibility of the implementation of a CES treatment regimen in a population of military beneficiaries with RLS by monitoring levels of interest in the study, recruitment time, attrition rates, and adherence to the study protocol; and (2) gather preliminary data using CES to compare differences in RLS symptom severity and quality of life in individuals randomized to one of three study groups: a usual care group, an inactive (sham) device group, or an active CES device group. Because the personal impact of living with RLS has not been explored fully in the published literature, a third aim is (3) to describe the experience of individuals coping with the chronic symptoms of RLS and the impact of this disorder on their quality of life. Measurements of RLS symptom severity and quality of life will be collected over a period of 8 weeks and group differences over time will be analyzed using mixed linear models. Qualitative interview data will be analyzed using descriptive phenomenological methods. Findings from this study will inform the design and implementation of a larger study to establish the effectiveness of CES on RLS symptoms. Qualitative findings will provide much needed information on the priorities for future research and clinical management based on patients' perspectives. The ultimate goal of the research is to identify and to evaluate the comparative effectiveness of non-pharmacological treatments for RLS symptom management.

Conditions

Restless Legs Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Usual Care

Participants in this group will continue receiving their previously prescribed therapy during the 8 week data collection period.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Active CES Device

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.

Group Type: ACTIVE_COMPARATOR

Active CES Device Alpha-Stim®

Intervention Type: DEVICE

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.

Sham CES 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.

Group Type: PLACEBO_COMPARATOR

Sham Device

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Other Intervention Names

Alpha-Stim®; Cranial electrotherapy stimulator; Cranial electical stimulation therapy; microcurrent electrical therapy

Eligibility Criteria

Inclusion Criteria

• Department of Defense Health Care Beneficiary
• A diagnosis of RLS, using criteria established by the International Restless Legs Study Group
• Currently symptomatic
• A period of 4 weeks of stable medication usage
• Over the age of 18
• Able to read, write and understand English.

Exclusion Criteria

• Pacemaker or other implanted electrical device
• Pregnancy or breastfeeding
• Inadequately treated primary cause of RLS (i.e., iron deficiency) based on screening laboratory testing
• Lack of a formal diagnosis of RLS

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Virginia

OTHER

Sponsor Role: collaborator

Tripler Army Medical Center

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Terri L Yost, PhD

Role: PRINCIPAL_INVESTIGATOR

Walter Reed National Military Medical Center

Locations

Tripler Army Medical Center

Honolulu, Hawaii, United States

Countries

United States

Other Identifiers

52H13

Identifier Type: -

Identifier Source: org_study_id