臨床研究等提出・公開システム

Transcutaneous electrical nerve stimulation for Sjogren's disease (VNS for Sjogren's disease)

Transcutaneous electrical nerve stimulation for Sjogren's disease (VNS for Sjogren'sdisease)

Nakamura Hiroyuki

Hookaido university hospital

Kita14, Nishi5, Kita-Ku, Sapporo Hokkaido

hirohironakamu@gmail.com

Nakamura Hiroyuki

Hookaido university hospital

Kita14, Nishi5, Kita-Ku, Sapporo Hokkaido

+81-11-706-5915

hirohironakamu@gmail.com

Pending

Feb. 13, 2026

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

other

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

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.

Female

Sjogren's disease

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.

ESSPRI score

+81-11-706-7934

Jan. 19, 2025

No

none