N/A
N=8
Treatment of RLS/WED Symptoms Through Sensory Counter-stimulation
Restless Legs Syndrome · Willis-Ekbom Disease
Bottom Line
View on ClinicalTrials.gov: NCT03249779 ↗Enrolled (actual)
8
Serious AEs
0.0%
Results posted
Sep 2019
Primary outcome: Primary: Change in International Restless Legs Syndrome Rating Scale (IRLS) — 19.5 score on a scale — p=0.0396
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Scrambler (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Jun 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in International Restless Legs Syndrome Rating Scale (IRLS) |
20.25 | 0.1330 |
| PRIMARY Change in International Restless Legs Syndrome Rating Scale (IRLS) |
20.25 | 0.1330 |
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 restless legs syndrome/Willis Ekbom Disease (RLS/WED).
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
Data sourced from ClinicalTrials.gov (NCT03249779). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.