Electrical contrastimulation on the calf for Restless Legs

Completed

• Conditions: Restless Legs Syndrome

• Registration Number: NL-OMON27456
• Lead Sponsor: Relegs

Brief Summary

/A

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 IRLSSG;
-RLS attack = once a week.

IRLSSG: International Restless Legs Syndrome Study Group

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Visual Analog Scale on RLS symptoms (VAS).

Secondary Outcome Measures

Name	Time	Method
RLS severity (IRLS), Sleep (MOS-sleep), Quality of Life (RLS-QoL) and Safety (Registering adverse reactions and serious adverse events).