Tokyo, Nov. 25 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059673) titled 'Exploratory Clinical Trial of Low Frequency Therapy for Primary Sclerosing Cholangitis' on Nov. 25.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - Hokkaido University

Condition: Condition - Primary sclerosing cholangitis Classification by malignancy - Others Genomic information - YES

Objective: Narrative objectives1 - Primary sclerosing cholangitis (PSC) is a progressive chronic intrahepatic biliary stasis disease with poor prognosis caused by fibrous stenosis of intrahepatic and extrahepatic bile ducts of unknown cause. On the other hand, the vagus nerve plays a role in regulating inflammatory responses and immune function, in addition to modulating many physiological responses, making vagus nerve stimulation a promising new treatment for a variety of diseases. Recently, transcutaneous auricular vagus nerve stimulation (taVNS) has been investigated. In this study, we aim to evaluate the efficacy, safety, and incidence of adverse events in improving liver injury/serum hepatobiliary enzyme abnormalities by administering taVNS to patients with PSC. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Treatment of transcutaneous auricular vagus nerve stimulation: taVNS

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key 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. Key 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 Target Size - 20

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 09 Month 17 Day Date of IRB - 2025 Year 09 Month 17 Day Anticipated trial start date - 2025 Year 11 Month 25 Day Last follow-up date - 2030 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066590

Disclaimer: Curated by HT Syndication.