Treatment of RLS/WED Symptoms Through Sensory Counter-stimulation

NCT03249779 | Completed Results

• 1 other identifier: 16-005286
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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).

Conditions

Restless Legs Syndrome; Willis-Ekbom Disease

Outcome Measures

Primary Outcomes (2)

• Change in International Restless Legs Syndrome Rating Scale (IRLS)

  The International Restless Legs Syndrome Rating Scale (IRLS) questionnaire will be used for this purpose. The IRLS is a validated patient-reported outcome measure to accurately assess disease severity of restless legs syndrome. It has questions on the primary features of restless legs syndrome, along with intensity and frequency, associated sleep problems. For this study subjects were asked to answer 10 questions on how often they experienced each symptom, using a score of 0-4, 0 being "None" and 4 being "Very severe." Answers from these questions were combined to provide a total Restless Legs Syndrome score (for a total possible range of 0-40) for each patient at each visit. Lower scores reflected fewer symptoms and higher scores reflected more symptoms.

  baseline, 2 weeks

• Change in International Restless Legs Syndrome Rating Scale (IRLS)

  The International Restless Legs Syndrome Rating Scale (IRLS) questionnaire will be used for this purpose. The IRLS is a validated patient-reported outcome measure to accurately assess disease severity of restless legs syndrome. It has questions on the primary features of restless legs syndrome, along with intensity and frequency, associated sleep problems. For this study subjects were asked to answer 10 questions on how often they experienced each symptom, using a score of 0-4, 0 being "None" and 4 being "Very severe." Answers from these questions were combined to provide a total Restless Legs Syndrome score (for a total possible range of 0-40) for each patient at each visit. Lower scores reflected fewer symptoms and higher scores reflected more symptoms.

  baseline, 1 week post treatment (approximately 3 weeks)

Study Arms (1)

Scrambler

EXPERIMENTAL

All participants will receive electrical stimulation applied to the lower extremities using the Scrambler.

Device: Scrambler

Interventions

Scrambler DEVICE

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

Scrambler

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Restless Legs Syndrome

Condition Hierarchy (Ancestors)

Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Parasomnias; Mental Disorders

Results Point of Contact

• Title: Melissa C. Lipford, M.D.
• Organization: Mayo Clinic

Lipford.Melissa@mayo.edu

507-255-9230

Study Officials

• Melissa Lipford, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 13, 2016
• First Posted: August 15, 2017
• Study Start: December 1, 2016
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: September 4, 2019
• Results First Posted: September 4, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)