Electrical contrastimulation on the calf for Restless Legs

Completed

• Conditions: Restless Legs Syndrome (RLS); Willis Ekbom disease; 10040998

• Registration Number: NL-OMON48228
• Lead Sponsor: Relegs

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 12

Inclusion Criteria

* Age >18 < 80 yrs;
* 5 essential diagnostic criteria RLS according to IRLSSG;
* RLS attack * once a week.IRLSSG <= International Restless Legs Syndrome Study
Groupormuli

Exclusion Criteria

* RLS medication
* Cardiac pacemaker, Implanted defibrillator, Transdermal drug delivery system
* Open wounds, skin eruptions or infected areas on legs/calves
* Lack of normal sensation in legs/calves
* Deep vein thrombosis during last 6 months
* Another sleep disorder
* Another movement disorder (e.g. Parkinson disease, dyskinesia, or dystonia)
* Epilepsy
* Pregnancy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Difference in VAS score before and after the use of LEX0 during an RLS attack.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Difference in MOS-sleep before and after 4 weeks of LEX0 use in home<br /><br>environment.<br /><br>- Difference in RLS-QoL score before and after 4 weeks of LEX0 use in home<br /><br>environment.<br /><br>- Difference in IRLS score before and after 4 weeks of LEX0 use in home<br /><br>environment.<br /><br>- Registering adverse reactions and serious adverse events. </p><br>