Overview

This trial is active, not recruiting.

Condition restless legs syndrome
Treatments active ces device alpha-stim®, sham device
Sponsor Tripler Army Medical Center
Collaborator University of Virginia
Start date February 2014
End date February 2017
Trial size 48 participants
Trial identifier NCT02419014, 52H13

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(No Intervention)
Participants in this group will continue receiving their previously prescribed therapy during the 8 week data collection period.
(Active Comparator)
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.
active ces device alpha-stim® 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.
(Placebo Comparator)
The inactive (sham) devices look identical to the active device but are inactivated by the manufacturer so as not to deliver any electrical current.
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.

Primary Outcomes

Measure
Change in International Restless Legs Syndrome Study Group Rating Scale (IRLS) from baseline and weekly for 8 weeks post intervention
time frame: At baseline then every week for 8 weeks

Secondary Outcomes

Measure
Qualitative Data Interview
time frame: Approximately 30-60 minute interview at any point during the study enrollment
Change in The Hopkins Restless Legs Syndrome Quality of Life Scale (RLS-QOL) from baseline at 4 and 8 weeks post intervention
time frame: At baseline then at weeks 4 and 8
Change in the RAND 36-item Health Survey (RAND-36) from baseline at 4 and 8 weeks post intervention
time frame: At baseline then at weeks 4 and 8
Change in the Fatigue Severity Scale (FSS) from baseline weekly for 8 weeks post intervention
time frame: At baseline then every week for 8 weeks
Change in the Pittsburgh Sleep Quality Index (PSQI) from baseline at 4 and 8 weeks post intervention
time frame: At baseline then at weeks 4 and 8

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Cranial Electrotherapy for Military Beneficiaries With Restless Legs Syndrome
Principal investigator Terri L Yost, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Tripler Army Medical Center.