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NCT02419014 · ClinicalTrials.gov registry record · NA

Cranial Electrotherapy for Military Beneficiaries With Restless Legs Syndrome

A NA study, sponsored by Tripler Army Medical Center.

Completed
Registry status
NA
Development phase
48
Enrollment target

NCT02419014: Completed NA study, sponsored by Tripler Army Medical Center.

NCT02419014 is a NA study that has completed, run by Tripler Army Medical Center. The registered enrollment target is 48 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02419014, a NA study, has completed, sponsored by Tripler Army Medical Center.

COMPLETED
Registry status
NA
Development phase
48 participants
Enrollment target

Study 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.

Primary Outcome

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 demonstrate

Interventions

  • DEVICE Sham Device
  • DEVICE Active CES Device Alpha-Stim®

Trial Details

FieldValue
Enrollment Target 48 participants
Start Date 2014-02
Est. Completion 2017-02
Phase NA
Tripler Army Medical Center

8 total trials

What the finished NCT02419014 record still lists

NCT02419014 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).

The record links to 0 conditions, and to 2 interventions - of which Sham Device is the first listed.

NCT02419014 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02419014 about?

NCT02419014 is a clinical study titled "Cranial Electrotherapy for Military Beneficiaries With Restless Legs Syndrome". 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...

What is the current status of trial NCT02419014?

This trial is currently completed. It is a NA study. The enrollment target is 48 participants. The study started on 2014-02. Estimated completion is 2017-02.

What interventions are being tested in trial NCT02419014?

The interventions under investigation include: Sham Device (DEVICE), Active CES Device Alpha-Stim® (DEVICE).

Who is sponsoring clinical trial NCT02419014?

This trial is sponsored by Tripler Army Medical Center, which has 8 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02419014's enrollment target sits among peer trials

48 1381st of 2000 higher than 601 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02419014, the US trial registry maintained by the National Library of Medicine. NCT02419014 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.