NIPH Clinical Trials Search

VNS for chronic Graft-Versus-Host disease

Basic Information

Recruitment status	Pending
Health condition(s) or Problem(s) studied	chronic GVHD
Date of first enrollment	13/02/2026
Target sample size	30
Countries of recruitment
Study type	Interventional
Intervention(s)	Low frequency therapy devices (Ito Ultrashort Wave ESPURGE (approximately 20 units anticipated) or modified Clark VN units based on PICORINA (units modified from PICORINA to apply as low frequency therapy devices and equipped with needles replaced by pads (approximately 10 units anticipated)) Treatment is administered using the device). Avoid bathing during stimulation. Walking and moving are permitted, but avoid activities that could displace the electrodes. Using the toilet, eating, and sleeping during stimulation are acceptable. Attach the electrodes to the auricle with adhesive patches and administer stimulation once daily for one hour. If interrupted, adjust the stimulation to ensure a total of one hour is administered within the day. Stimulation is performed using 1.5mA, 25Hz, and 250usec as the baseline. However, as habituation may occur, the research team will adjust the settings within the range of 1to20mA and 2to100Hz, aiming for a level where a crackling sensation is felt but no pain is experienced. Regarding the mode, the ESPUERGE device should be used in EMS mode, and the modified PICORINA device (Clark VN) should be used in modulation mode.

Outcome(s)

Primary Outcome

Overall response rate (ORR) of chronic GVHD at Week 28 based on NIH Consensus Criteria following low-frequency therapy

Secondary Outcome

Incidence of adverse events associated with low-frequency therapy. Change in forced expiratory volume in 1 second (FEV1) on pulmonary function tests from baseline to Week 28. Best Overall Response (BOR) rate observed from baseline to Week 28. Change in the Lee Symptom Scale score from baseline to Week 28. Changes in the dosage and types of concomitant medications for chronic GVHD from baseline to Week 28. Failure-Free Survival (FFS) from baseline to Week 28. (Failure is defined as death, progression of chronic GVHD based on NIH Consensus Criteria, initiation of new systemic therapy for chronic GVHD, or increase in the dosage or types of concomitant medications for chronic GVHD.) Association between pathophysiology and the localization of immune cells, expression positivity/intensity of inflammation-induced molecules, and presence of disease-related gene variants before and after low-frequency therapy; and correlations between inflammatory status, clinicopathological factors, and expression status of other analyzed molecules.

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender
Include criteria	Patients with chronic GVHD who are receiving outpatient care or hospitalized at Hokkaido University Hospital or Sapporo hokuyu Hospital between the date of implementation approval and January 31, 2028
Exclude criteria	Patients meeting any of the following criteria will be excluded from the study: Patients with a history of progressive brain lesions. Patients concurrently receiving Vagus Nerve Stimulation (VNS) therapy. Patients with a history of severe cardiovascular disease. Patients with a history of hypersensitivity to glycerin. Patients with a confirmed recurrence of a malignant tumor. Patients who are pregnant or breastfeeding. Patients with difficulty in oral intake. Patients with a history of dermatological reactions to metals or other substances. Patients with an implanted cardiac pacemaker or an implantable cardioverter-defibrillator (ICD). Any other patients deemed unsuitable for the study by the Principal Investigator or Sub-investigator.