Treatment of RLS/WED Symptoms Through Sensory Counter-stimulation

Overview

  • Study type

    Interventional
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Rochester, Minnesota: 16-005286
    NCT ID: NCT03249779
    Sponsor Protocol Number: 16-005286

About this study

To evaluate, in a pilot fashion, efficacy and tolerability of electrical counter-stimulation using the Scrambler device in alleviating uncomfortable sensations and urge to move in patients with restless legs syndrome/Willis Ekbom Disease (RLS/WED).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria:

  • Male and female patients age 18 and over diagnosed with RLS/WED by a board certified sleep medicine physician within the Mayo Clinic Center for Sleep Medicine.
  • Patients must have moderate to severe symptoms which have been present for ≥ 3 months. Patients must endorse discomfort as part of their typical RLS/WED symptomatology.
  • Patients must experience daily symptoms and must experience daily symptoms during afternoon hours (12-5 PM)
  • Patients on no medications for RLS/WED, or those who have refractory symptoms despite RLS/WED medications will be enrolled. Patients on alpha-2-delta ligands (pregabalin, gabapentin) will be asked to discontinue these medications two weeks prior to starting treatments and remain off these medications throughout the study protocol.
  • Informed consent to participate in this study needs to be obtained

Exclusion Criteria:

  • Research authorization not provided
  • Patients who are asymptomatic (either by verbal report or completion of severity scale) at time of initiation of Scrambler Therapy treatment
  • Patients who have made changes in medication regimen during the 2 weeks prior to study initiation (including initiation of iron supplementation)
  • Prior use of Scrambler Therapy
  • Pregnant or Nursing Patients
  • Patients with implantable drug delivery systems, heart stents, or metal implants (including pacemakers and defibrillators)
  • Patients with history of epilepsy or other medical conditions that in the opinion of the investigators should be excluded
  • Patients with skin conditions or wounds in or around the area of electrode application (lower extremities)
  • Patients treated with alpha-2 delta ligands (gabapentin, pregabalin), who cannot discontinue the medications as above

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Melissa Lipford, M.D.

Open for enrollment

Contact information:

Boleyn Andrist CCRP

(507)284-9946

Andrist.Boleyn@mayo.edu

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CLS-20301656

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