Clinical trial NCT03249779: Treatment of RLS/WED Symptoms Through Sensory Counter-stimulation
Official title: Electrical Stimulation Via the Scrambler Device as a Treatment for Restless Legs Syndrome/Willis Ekbom Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Restless Legs Syndrome
Willis-Ekbom Disease
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2017-08-15
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

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

Primary outcomes:
measure: Change in International Restless Legs Syndrome Rating Scale (IRLS)
timeFrame: baseline, 2 weeks
measure: Change in International Restless Legs Syndrome Rating Scale (IRLS)
timeFrame: baseline, 1 week post treatment (approximately 3 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Melissa Lipford, MD
role: PRINCIPAL_INVESTIGATOR
References: