Effect of tDCS on RLS symptom: randomized, double-blind, sham-controlled, proof-of-concept study
- Conditions
- Diseases of the nervous system
- Registration Number
- KCT0000618
- Lead Sponsor
- Korea University Anam Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 33
1) duration of RLS = 1 year,
2) having symptoms = 3 times per week, and
3) International RLS Study Group Rating Scale (IRLS) = 20, indicating severe symptomatology
1) significant comorbidities likely to be associated with secondary RLS, such as anemia, pregnancy, chronic kidney disease, or peripheral neuropathy,
2) presence of cognitive disorders that prevented participants from describing their symptoms,
3) presence of disorders with symptoms similar to RLS, such as attention deficit hyperactivity disorder, essential tremor, Parkinson’s disease, neuroleptic-induced akathisia, congestive heart failure, vascular claudication, neurogenic claudication, myelopathy, and arthritis ,
4) those who were taking medications that can affect the central nervous system, and
5) those who had metallic objects in their bodies, such as a pacemaker or internal metallic objects in the brain.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method IRLS (the International Restless Legs Syndrome Study Group Rating Scale);CGI(Clinical Global Impression) global improvement,
- Secondary Outcome Measures
Name Time Method PGI(Patient Global Impression) change;PGI(Patient Global Impression) change;the Pittsburgh Sleep Quality Index;the Medical Outcome Study (MOS) sleep subscales;the Korean version of the Beck Depression Inventory, version II (BDI-II);visual analog scale (VAS) scores ;Subjective Post-Sleep Diary (SPSD);type, frequency, and severity of adverse effects