NCT03249779

Treatment of RLS/WED Symptoms Through Sensory Counter-stimulation

Electrical Stimulation Via the Scrambler Device as a Treatment for Restless Legs Syndrome/Willis Ekbom Disease

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

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. Subjects must experience daily symptoms and must typically be symptomatic during the timeframe in which Scrambler Therapy will be utilized (12-5 PM). Each patient will complete the International Restless Legs Syndrome Rating Scale (IRLS), a validated scale which assesses severity of RLS symptoms16 at baseline (pre-treatment) and before and directly after each session of Scrambler Therapy. Patients will receive Scrambler Therapy on a daily basis for up to 10 consecutive weekdays. Electrodes will be placed proximal to the area of RLS symptomatology, with gradual downward localization until the entire area of RLS symptoms has been treated. Treatment will initially take place on one leg. Treatments will be administered by a technician trained in using the Scrambler device. A physician or nurse (with familiarity of Scrambler therapy) will be available throughout each treatment session. Patients will complete questionnaires regarding discomfort or other side effects encountered during or after treatment. Patients will also complete surveys assessing for any changes (benefits or worsening) in RLS symptomatology between treatments. Patients will be monitored for any adverse events associated with the study procedures. Any reported adverse events will be expediently classified by the study group as to severity level, whether it relates to the treatments in the study protocol, and whether the event was expected or unexpected. This information will allow determination of whether or not the adverse event should be reported as an expedited report or part of the routinely reported outcomes data. All adverse events which meet criteria for expedited reporting will be reported to the institutional IRB as well as external agencies as required. If there is no evidence of clinical benefit with the first 2-4 patients, then further patients may not be recruited.

Conditions

• Restless Legs Syndrome
• Willis-Ekbom Disease

Interventions

Type	Name	Description
DEVICE	Scrambler	Scrambler Therapy is a specific form of electrical stimulation which has also been utilized in chronic neurogenic pain11. This modality of therapy differs from TENS in that the goal is to mediate the patient's perception of pain, rather than masking the peripheral pain signal. The results of this modality of treatment may be longer-lasting than TENS, presumably via reduction in central signal generation. Scrambler therapy works through C fibers to retrain the peripheral sensation in the area being treated. Further description of this technology is available at: International Patent PCT/IT2007/000647 and U.S. Patent No. 8,380,317. Literature search does not yield prior studies regarding efficacy of Scrambler therapy in treating RLS

Timeline

• Start date: 2016-12-01
• Primary completion: 2018-06-01
• Completion: 2018-06-01
• First posted: 2017-08-15
• Last updated: 2019-09-04
• Results posted: 2019-09-04

Locations

1 site across 1 country: United States