MedPath

se of transcutaneous electric nerve stimulation for treatment of restless leg syndrome associated with chronic liver disaese

Phase 3
Conditions
Health Condition 1: G258- Other specified extrapyramidal andmovement disorders
Registration Number
CTRI/2023/06/053734
Lead Sponsor
Dr. Vimal Kumar Paliwal
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

Patients of Chronic Liver Disease defined by progressive deterioration of liver function over 6

months, with age > 18 years, attending Gastromedicine / Neurology OPD at SGPGI and

diagnosed with RLS as defined by the International RLS Study Group with Serum Ferritin > 75 ng/ ml at presentation or Non improvement of RLS Symptoms after 6 weeks of Intravenous iron therapy in case with Serum Ferritin < 75 ng/ml.

Exclusion Criteria

1. Active alcohol intake

2. Chronic Kidney diseasedefined by eGFR < 60

3. Recent Hospitalization / recent clinical worsening ( < 4 weeks ) for deteriration of liver function of liver function as evidenced by new appearance or worsening of ascites or encephalopathy or jaundice, or reduction of urine output , or gastrointestinal bleeding

4. Neurological illnesses like epilepsy disorder/ neuropathy / multiple sclerosis / spinal cord diseases 5. Pregnancy 6. Patients of rls on ongoing treatment with alpha 2 delta ligands / dopaminergic agonists / opioids . 7. Localized skin eruptions 8. Pacemaker

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
© Copyright 2025. All Rights Reserved by MedPath