Primary sclerosing cholangitis
Conditions
Interventions
Treatment of transcutaneous auricular vagus nerve stimulation: taVNS
Sponsors
Hokkaido University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients who are 18 years of age or older at the time of obtaining consent 2) Patients who have been diagnosed with PSC based on clinical symptoms or pathological examination 3) Patients whose serum alkaline phosphatase (ALP) level is 1.5 times or more than the upper limit of normal, or whose Anali score is 1 or more. 4) Those who have been evaluated by MRCP (or US/CT if MRCP imaging is difficult) within 6 months. 5) Those who, after receiving sufficient explanation for participation in this study, are able to actively understand the consent document and give written consent of their own free will.
Exclusion criteria
Exclusion criteria: 1) Patients with chronicizing diseases other than PSC (viral hepatitis, metabolic-related liver diseases, alcoholic liver disorders, primary cholestatic cholangitis, Wilson's disease, etc.) 2) Patients with a certain degree of advanced liver damage (serum *AST or ALTNote) exceeding 10 times the upper limit of normal 3) Patients with a history of progressive brain lesions 4) Patients receiving concomitant vagus nerve stimulation therapy 5) Patients with a history of severe cardiovascular disease 6) Pregnant or lactating women 7) Patients with skin hypersensitivity and a history of skin manifestations due to metal or other substances 8) Patients with difficulty in oral intake 9) Patients with severe renal dysfunction (estimated glomerular filtration rate (eGFR) < 30 ml/min) 10) Patients with a cardiac pacemaker or an implantable cardioverter-defibrillator 11) Other subjects who are deemed inappropriate as research subjects by the Principal Investigator or the Principal Investigator. *AST, aspartate aminotransferase; ALT, alanine aminotransferase
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in serum ALP levels and Anali score* from study start to 52 weeks post-test | — |
Countries
Japan
Contacts
Public ContactMasaki Kuwatani
Hokkaido University Hospital Department of Gastroenterology and Hepatology
Outcome results
None listed