Status:
COMPLETED
Treatment of RLS/WED Symptoms Through Sensory Counter-stimulation
Lead Sponsor:
Mayo Clinic
Conditions:
Restless Legs Syndrome
Willis-Ekbom Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 restle...
Detailed Description
A total of up to 10 eligible subjects will be recruited who have been diagnosed with chronic RLS/WED (Restless legs syndrome/ Willis Ekbom Disease) in the Mayo Clinic Center for Sleep Medicine. Subjec...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2018
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT03249779
Start Date
December 1 2016
End Date
June 1 2018
Last Update
September 4 2019
Active Locations (1)
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1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905