ekbom's syndroom restless legs
Conditions
Interventions
None listed
Sponsors
Medisch Centrum Haaglanden
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: Patient*s age must be between 18-65 years old; Patients must have definite RLS as defined by the International Restless Legs Syndrome Study Group (IRLSSG). This means that all of the four main criteria must be fulfilled (2); Patient must have severe RLS as measured by the John Hopkins RLS Severity scale (JHRLSS); score 2 or higher (3); Patient must score more than 15 on the International Restless Legs Severity Scale (IRLSS) in which item seven is answered with 6-7 days a week (score 4) (7); Patients are not allowed to receive any treatment for RLS during the study (including benzodiazepines). If patients already received therapy for the RLS they will be asked to stop their medication two weeks prior to the study.
Exclusion criteria
Exclusion criteria: Exclusion criteria: Patient will be excluded if: They use medication known to affect sleep or motor behaviour, such as stimulants, hypnotics, neuroleptics or antidepressants; They have medical conditions known to be associated with RLS, i.e. iron deficiency, peripheral neuropathy, end-stage renal disease, pregnancy, hypothyroidism; They have other sleep disturbances such as sleep apnoea, narcolepsy, parasomnia or primary or secondary insomnia (other than caused by RLS) as established by patient interview; They cannot bear the stimulus intensity that is needed for a good reproducible SSEP; It is not possible to reproduce a SSEP from the posterior tibial nerve on one side or both sides of the leg; They have neurological (other than RLS) or psychiatric diseases.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome: The influence of an electrical stimulus on: sensory symptoms in RLS measured by *the area under the curve* of the VAS-scores gained during the three different study conditions. motor symptoms in RLS measured by *The Periodic Limb Movement Index* gained during the three different study conditions. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome: Differences in latencies and amplitudes between the SSEP measured before and after electrical stimulation (as in condition 2, see below). | — |
Countries
Netherlands
Outcome results
None listed