Restless Legs Syndrome
Conditions
Interventions
Subjects are instructed to use LEX0 for 4 weeks in home environment for their restless legs, as needed. An user manual is handed. In the event of an RLS attack, LEX0 is placed with the electrode patch
Sponsors
Relegs
Eligibility
Inclusion criteria
Inclusion criteria: - age >18 < 80 yrs; - 5 essential diagnostic criteria RLS according IRLSSG; - RLS attack = once a week. IRLSSG: International Restless Legs Syndrome Study Group
Exclusion criteria
Exclusion criteria: - RLS medication - Cardiac pacemaker, Implanted defibrillator, Transdermal drug delivery system - Open wounds, skin eruptions or infected areas on legs - Lack of normal sensation in legs - Deep vein thrombosis during last 6 months - Another sleep disorder - Another movement disorder (e.g. Parkinson disease, dyskinesia, or dystonia) - Epilepsy - Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Visual Analog Scale on RLS symptoms (VAS). | — |
Secondary
| Measure | Time frame |
|---|---|
| RLS severity (IRLS), Sleep (MOS-sleep), Quality of Life (RLS-QoL) and Safety (Registering adverse reactions and serious adverse events). | — |
Contacts
Public Contactcasper van waveren Hogervorst
Centrum Oosterwal
Outcome results
None listed