Cranial Electrotherapy for Military Beneficiaries With Restless Legs Syndrome

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.

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