Objective: The aim of the study is to investigate whether afferent sensory input reduces the sensory and motor symptoms in RLS patients. By performing a SomatoSensory Evoked Potential (SSEP) we will also look at the central conduction time of an…
ID
Source
Brief title
Condition
- Sleep disturbances (incl subtypes)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
Secondary outcome:
Differences in latencies and amplitudes between the SSEP measured before and
after electrical stimulation (as in condition 2, see below).
Background summary
Rationale: Restless Legs Syndrome (RLS) is characterised by the occurrence of
unpleasant and/ or disabling symptoms at rest, associated with an urge to move
(motor symptoms). These symptoms begin or worsen during rest or inactivity and
occur mostly at evening or night. They are relieved by voluntary movement at
least as long as the activity continues. Besides that, a diversity of sensory
input may reduce the RLS symptoms. Until now there are no systematic studies on
external sensory input reducing RLS symptoms. To gain insight into the
pathophysiological mechanism of RLS, we perform a study to test the effect of
sensory input on the severity on RLS symptoms.
Study objective
Objective: The aim of the study is to investigate whether afferent sensory
input reduces the sensory and motor symptoms in RLS patients. By performing a
SomatoSensory Evoked Potential (SSEP) we will also look at the central
conduction time of an electrical stimulus in RLS patients.
Study design
Study design: We will conduct pathophysiological study with RLS patients.
Measurements will be done during the evening as RLS patients have most
complaints during the evening and night. All patients will undergo three study
conditions. During these three study conditions patients will undergo the SIT.
To measure RLS symptoms patients will be asked to fill in a VAS scoring list.
Furthermore involuntary leg movements will be recorded by EMG. Depending on the
study conditions, patients will receive an electrical stimulus on both legs. To
control for the twitch of the big toe, caused by this electrical stimulus, a
third study condition is created in which the stimulus intensity remains the
same but the stimulator is moved to prevent the twitch of the big toe.
Additionally a SSEP will be made four times during the study. The order in
which patients will take the different study conditions will be randomised.
Study burden and risks
Ethical aspects: Two weeks before start of the study patients are asked to stop
their medication which will induce return or worsening of RLS symptoms.
However, this will not put patients at risk for physical injury whatsoever.
Furthermore, patients are asked to come to the Holland Sleep Centre and the
Medical Centre Haaglanden for one evening. All of the survey methods used in
this study are completely safe and are used in daily clinical practise.
lijnbaan 32
2501 CK den haag
Nederland
lijnbaan 32
2501 CK den haag
Nederland
Listed location countries
Age
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:
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
Recruitment
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
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In other registers
| Register | ID |
|---|---|
| CCMO | NL16647.098.07 |