Suppression of Restless Legs Syndrome (RLS) by Changes in Afferent Input

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 18

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

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.

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary outcome:<br /><br>The influence of an electrical stimulus on:<br /><br>sensory symptoms in RLS measured by the area under the curve of the<br /><br>VAS-scores gained during the three different study conditions.<br /><br>motor symptoms in RLS measured by The Periodic Limb Movement Index gained<br /><br>during the three different study conditions.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcome:<br /><br>Differences in latencies and amplitudes between the SSEP measured before and<br /><br>after electrical stimulation (as in condition 2, see below).</p><br>