Ensayos clínicos

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