NIPH Clinical Trials Search

Transcutaneous electrical nerve stimulation for Sjogren's disease

Basic Information

Recruitment status	Pending
Health condition(s) or Problem(s) studied	Sjogren's disease
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	ESSPRI score
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	<= 65age old
Gender	Female
Include criteria	Patients with Sjogren's syndrome who are receiving outpatient care or hospitalized at Hokkaido University Hospital, Nagasaki University Hospital, or Tsukuba University 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 (or progressive cerebral disorders). 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 who are pregnant or breastfeeding. Patients with skin hypersensitivity who have a history of dermatological reactions to metals or other substances. Patients with difficulty in oral intake. Patients with an implanted cardiac pacemaker or an implantable cardioverter-defibrillator (ICD). Patients using immunosuppressants (such as glucocorticoids, methotrexate, azathioprine, mycophenolic acid, tacrolimus, or cyclosporine) or hydroxychloroquine. Any other patients deemed unsuitable for the study by the Principal Investigator or Sub-investigator.