Treatment of RLS/WED Symptoms Through Sensory Counter-stimulation
Completed · Not applicable
Conditions studied: Restless Legs Syndrome, Willis-Ekbom Disease
In brief
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).
Key facts
- Study ID
- NCT03249779
- Run by
- Mayo Clinic
- People needed
- 8
- Starts
- 2016-12-01
- Expected to finish
- 2018-06-01
- Last updated by the study team
- 2019-09-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Mayo Clinic in Rochester — Rochester, Minnesota, United States
Full record on ClinicalTrials.gov
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