Clinical trial NCT02419014: Cranial Electrotherapy for Military Beneficiaries With Restless Legs Syndrome
Official title: Cranial Electrotherapy for Military Beneficiaries With Restless Legs Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Restless Legs Syndrome
Keywords: cranial electrotherapy
cranial electrical stimulation
restless legs syndrome
Lead sponsor: Tripler Army Medical Center
Sponsor class: FED
Collaborators: name: University of Virginia
First posted: 2015-04-17
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in International Restless Legs Syndrome Study Group Rating Scale (IRLS) from baseline and weekly for 8 weeks post intervention
timeFrame: At baseline then every week for 8 weeks
Secondary outcomes:
measure: Qualitative Data Interview
timeFrame: Approximately 30-60 minute interview at any point during the study enrollment
measure: Change in The Hopkins Restless Legs Syndrome Quality of Life Scale (RLS-QOL) from baseline at 4 and 8 weeks post intervention
timeFrame: At baseline then at weeks 4 and 8
measure: Change in the RAND 36-item Health Survey (RAND-36) from baseline at 4 and 8 weeks post intervention
timeFrame: At baseline then at weeks 4 and 8
measure: Change in the Fatigue Severity Scale (FSS) from baseline weekly for 8 weeks post intervention
timeFrame: At baseline then every week for 8 weeks
measure: Change in the Pittsburgh Sleep Quality Index (PSQI) from baseline at 4 and 8 weeks post intervention
timeFrame: At baseline then at weeks 4 and 8
Other outcomes:
Locations:
city: Honolulu
country: United States
facility: Tripler Army Medical Center
state: Hawaii
Study officials:
affiliation: Walter Reed National Military Medical Center
name: Terri L Yost, PhD
role: PRINCIPAL_INVESTIGATOR
References: