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Effect of tDCS on RLS symptom: randomized, double-blind, sham-controlled, proof-of-concept study

Efficacy of transcranial direct current stimulation in patients with drug-naive restless legs syndrome

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0000618
Enrollment
33
Registered
2012-12-28
Start date
2013-01-07
Completion date
Unknown
Last updated
2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device : Treatments were performed by a trained investigator who had no knowledge of the subjects’ group assignment. During each session, a direct current was transferred using a saline-soaked

Sponsors

Korea University Anam Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
IRLS (the International Restless Legs Syndrome Study Group Rating Scale);CGI(Clinical Global Impression) global improvement,

Secondary

MeasureTime frame
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

Countries

Korea, Republic of

Contacts

Public ContactMI-Ae Lee

Korea University Anam Hospital

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026