Treatment of RLS/WED Symptoms Through Sensory Counter-stimulation
Overview
Tab Title Description
Study type
InterventionalDescribes 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.
Study IDs
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. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
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 the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Melissa Lipford, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available