CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 8 enrolled
Drug / intervention
Scramblerdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03249779
NCT03249779N/ACompleted

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

Mayo Clinic·interventional·Posted Aug 15, 2017·Updated Sep 4, 2019

In Brief

A clinical study evaluating Scrambler for Restless Legs Syndrome and Willis-Ekbom Disease. Completed, enrolled 8 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedAug 15, 2017
Enrollment StartDec 1, 2016
Primary CompletionJun 1, 2018
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 8.9 years ago

Interventions

Scramblerdevice

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