Restless Legs SyndromeCES in RLSNCT02419014
Cranial Electrotherapy for Military Beneficiaries With Restless Legs Syndrome
A study testing Active CES Device Alpha-Stim® in people with Restless Legs Syndrome, run by Tripler Army Medical Center at 1 site in United States.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Restless Legs Syndrome
- What is being tested?
- Active CES Device Alpha-Stim®
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to Feb 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Tripler Army Medical Center
Honolulu, Hawaii, 96859-5000
About this study
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.
Read the 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
- Being tested
- Active CES Device Alpha-Stim®, Sham Device
- Keywords
- cranial electrotherapy, cranial electrical stimulation, restless legs syndrome
- Medical subject headings
- Restless Legs Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active CES Device Alpha-Stim®Device
Also called Alpha-Stim®, Cranial electrotherapy stimulator, Cranial electical stimulation therapy, microcurrent electrical therapy
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 DeviceDevice
The inactive (sham) devices look identical to the active device but are inactivated by the manufacturer so as not to deliver any electrical current.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | Participants in this group will continue receiving their previously prescribed therapy during the 8 week data collection period. |
| Active CES Device | 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. Receives: Device: Active CES Device Alpha-Stim® |
| Sham CES Device | 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. Receives: Device: Sham Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in International Restless Legs Syndrome Study Group Rating Scale (IRLS) from baseline and weekly for 8 weeks post intervention
The IRLS consists of 10 questions, each with 5 possible responses geared towards assessing severity that range from no symptoms (0 points) to very severe symptoms (4 points). Scoring: Points for each response are added together to create a possible range of 0-40 with higher scores indicating worsening severity. Reliability and Validity: The IRLS demonstrated high internal consistency on 2 separate testing sessions (Cronbach's α of 0.93 and 0.95, respectively). Test/retest reliability demonstrated a correlation coefficient of 0.87 and paired t-test demonstrated stability over time.
Measured: At baseline then every week for 8 weeks
Secondary outcomes (5)
Qualitative Data Interview
The purpose of this interview is to learn more about the lived-experience of RLS from those suffering from it in an effort to direct future research and treatment priorities
Measured: 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
The RLS-QOL consists of 18 total items measuring the domains of life impact, employment/work and sexual interest. Scoring: 10 of the items are added together to represent overall life impact, 6 items address employment/work and 2 address sexual interest. Higher scores are indicative of a higher quality of life. Reliability and Validity: The RLS-QOL demonstrated high internal consistency on 2 separate testing periods (Cronbach's α of 0.82 and 0.87, respectively). Validity was assessed by comparison to the IRLS (moderate correlation -0.68 and -0.67). The instrument was further assessed for sensitivity to change by demonstrating a significant difference (p < 0.0001) in the overall life impact score after treatment.
Measured: 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
The scale consists of 36 items incorporating 8 domains of health: physical functioning; role limitations related to physical health; role limitations related to emotional health; energy/fatigue; emotional well-being; social functioning; pain; and general health. Scoring: A scoring key accompanies the instrument that links the specific item numbers to domains and instructs the scorer through conversion from the raw score to a scale score. Higher scores indicate higher quality of life. Reliability and Validity: Internal consistency of all domains was assessed with Cronbach's α ranging from 0.78 to 0.93, indicating high reliability.
Measured: At baseline then at weeks 4 and 8
Change in the Fatigue Severity Scale (FSS) from baseline weekly for 8 weeks post intervention
The FSS consists of 9 items for which participants identify their degree of agreement with the item on a 7-point Likert scale. Scoring: The FSS is scored by adding the numbers that are circled by participants and dividing by 9 to obtain an average score, which ranges from 1-7. Reliability and Validity: The FSS demonstrated high internal consistency in reliability testing with an overall Cronbach's α of 0.88. Test/retest stability over time demonstrated a correlation coefficient of 0.84. In t-tests assessing for responsiveness to change over time, clinical improvement after treatment for fatigue was associated with significant decreases in FSS score (p < 0.01).
Measured: 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
The PSQI (58) consists of 19 self-rated questions intended to discriminate between good sleepers and poor sleepers by measuring sleep habits on 7 different sleep domains: (1) subjective sleep quality; (2) sleep latency; (3) sleep duration; (4) habitual sleep efficiency; (5) sleep disturbances; (6) use of sleep medications; and (7) daytime dysfunction. Scoring: Scores are organized into the seven domains, which added together yield one global score ranging from 0-21 points. A lower score indicates low difficulty and a higher score indicates more severe difficulty within the identified domains. The seven domains combined have an overall reliability of 0.83 indicating high internal validity.
Measured: At baseline then at weeks 4 and 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2015 (estimated)
- Study startFeb 2014
- Primary completionFeb 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Restless Legs SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tripler Army Medical Center
- Sponsor type
- US federal agency
- Collaborators
- University of Virginia
- Responsible party
- Sponsor
- Investigators
- Terri L Yost, PhD, Principal investigator, Walter Reed National Military Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02419014
- Sponsor's protocol ID
- 52H13
- Acronym
- CES in RLS
- Status last verified
- Feb 2025
- First submitted
- 2 Apr 2015
- Last updated
- 10 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cranial Electrotherapy for Military Beneficiaries With Restless Legs Syndrome
- ClinicalTrials.gov ID
- NCT02419014
- Acronym / sponsor ID
- CES in RLS / 52H13
- Conditions
- Restless Legs Syndrome
- Keywords
- cranial electrotherapy, cranial electrical stimulation, restless legs syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Tripler Army Medical CenterUS federal agency
- Collaborators
- University of Virginia
- Study start
- Feb 2014
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 17 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –Participants in this group will continue receiving their previously prescribed therapy during the 8 week data collection period. |
| Active CES Device | Active comparator | 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. |
| Sham CES Device | Placebo comparator | Device: Sham DeviceThe inactive (sham) devices look identical to the active device but are inactivated by the manufacturer so as not to deliver any electrical current. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active CES Device Alpha-Stim®Also: Alpha-Stim®, Cranial electrotherapy stimulator, Cranial electical stimulation therapy, microcurrent electrical therapyThe 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 | Active CES Device |
| Sham DeviceThe inactive (sham) devices look identical to the active device but are inactivated by the manufacturer so as not to deliver any electrical current. | Device | Sham CES Device |
Primary outcome
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
The IRLS consists of 10 questions, each with 5 possible responses geared towards assessing severity that range from no symptoms (0 points) to very severe symptoms (4 points). Scoring: Points for each response are added together to create a possible range of 0-40 with higher scores indicating worsening severity. Reliability and Validity: The IRLS demonstrated high internal consistency on 2 separate testing sessions (Cronbach's α of 0.93 and 0.95, respectively). Test/retest reliability demonstrated a correlation coefficient of 0.87 and paired t-test demonstrated stability over time.
5 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2025.
Related trials for Restless Legs Syndrome
RecruitingObservational study
Lemborexant vs Clonidine vs Sedatives to Treat Insomnia in Chronic Pain Patients
Chronic Insomnia, Chronic Pain
Not yet recruiting
Neuromodulation to Overcome Severe Restless Legs Syndrome
Restless Leg Syndrome (RLS), Spinal Cord Stimulation (SCS)
Not yet recruitingPhase 2
Tolerability and Efficacy of CBD Extract for RLS Treatment
Restless Leg Syndrome
Recruiting
Functional Connectivity of the Interoceptive Network in RLS
Restless Legs Syndrome
Not yet recruitingPhase 2
Intravenous Iron in the Management of Drug-resistant Restless Legs syndromeI
Restless Legs Syndrome (RLS)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Terri L Yost, PhD principal investigator
Walter Reed National Military Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active CES Device Alpha-Stim® in people with Restless Legs Syndrome, run by Tripler Army Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2025.