Cranial Electrotherapy for Military Beneficiaries With Restless Legs Syndrome

NCT02419014 | Completed DMC

• 1 other identifier: 52H13
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Restless Legs Syndrome

Keywords

cranial electrotherapy; cranial electrical stimulation; restless legs syndrome

Outcome Measures

Primary Outcomes (1)

• 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.

  At baseline then every week for 8 weeks

Secondary Outcomes (5)

• Qualitative Data Interview

  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

  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

  At baseline then at weeks 4 and 8

• Change in the Fatigue Severity Scale (FSS) from baseline weekly for 8 weeks post intervention

  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

  At baseline then at weeks 4 and 8

Study Arms (3)

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.

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.

Device: Sham Device

Interventions

Active CES Device Alpha-Stim® 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.

Also known as: Alpha-Stim®, Cranial electrotherapy stimulator, Cranial electical stimulation therapy, microcurrent electrical therapy

Active CES Device

Sham Device 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.

Sham CES Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Tripler Army Medical Center: lead
• University of Virginia: collaborator

Study Sites (1)

Tripler Army Medical Center

Honolulu, Hawaii, 96859-5000, United States

Location

MeSH Terms

Conditions

Restless Legs Syndrome

Condition Hierarchy (Ancestors)

Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Parasomnias; Mental Disorders

Study Officials

• Terri L Yost, PhD

  Walter Reed National Military Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2015
• First Posted: April 17, 2015
• Study Start: February 1, 2014
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: February 10, 2025

Record last verified: 2025-02

Locations

US (1)