臨床研究等提出・公開システム

Transcutaneous electrical nerve stimulation for mental disease

Transcutaneous electrical nerve stimulation for mental disease

Kato Takahiro

Hokkaido university hospital

Kita14, Nishi5, Kita-Ku, Sapporo Hokkaido

takato.hokudai@gmail.com

Kato Takahiro

Hokkaido university hospital

Kita14, Nishi5, Kita-Ku, Sapporo Hokkaido

+81-11-716-1161

takato.hokudai@gmail.com

Pending

Aug. 04, 2026

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

other

Patients with uveitis who are receiving outpatient care or are hospitalized at Hokkaido University Hospital between the date of study approval and March 31, 2028, and who meet all of the following inclusion criteria:

Aged from 18 years to 65 years at the time consent is obtained
Patients who, after receiving a sufficient explanation of the study, are able to actively understand the written informed consent document on their own and who provide written consent of their own free will

Patients who meet any one of the following criteria will be excluded:

Patients with a history of progressive cerebral lesions
Patients undergoing concomitant vagus nerve stimulation therapy
Patients with a history of severe cardiovascular disease
Patients with a history of hypersensitivity to glycerin
Patients with an active malignant tumor
Patients who are pregnant or breastfeeding
Patients with a history of skin reactions caused by metals or similar materials
Patients using a cardiac pacemaker or an implantable cardioverter defibrillator
Patients otherwise judged by the principal investigator or a sub-investigator to be unsuitable as study participants

Both

Patients with psychiatric disorders presenting with hikikomori (social withdrawal)

Low frequency therapy devices (Ito Ultrashort Wave ESPURGE or Clark VN) 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 Clark VN should be used in modulation mode.

mental disease

D001523

Change in the HQ-25 total score from before the start of treatment to Week 52

Presence or absence of adverse events and other untoward findings associated with the administration of low-frequency therapy
Change from before the start of treatment to Week 52, before and after low-frequency therapy, in each score of the EQ-5D-5L and of psychological function assessments including psychiatric symptoms
Change from before the start of treatment to Week 52, before and after low-frequency therapy, in heart rate variability (an index of autonomic nervous activity) derived from time-series analysis of heart rate variability obtained with Heartnote
Change from before the start of treatment to Week 52, before and after low-frequency therapy, in frequency power spectral values derived from time-series analysis of heart rate variability obtained with Heartnote
Change from before the start of treatment to Week 52, before and after low-frequency therapy, in the SF-36 PF (Physical Functioning) score (in particular, assessment of physical function in myalgic encephalomyelitis/chronic fatigue syndrome)
Change from before the start of treatment to Week 52, before and after low-frequency therapy, in the mean daily step count (obtained from the accelerometer built into Heartnote or from a non-invasive physiological data acquisition device)
Presence or absence of exacerbation episodes during low-frequency therapy, from before the start of treatment through Week 52
Localization of immune cells before and after low-frequency therapy; positivity and intensity of expression of molecules whose expression is induced by inflammation; and the presence or absence of disease-associated gene variants and their relationship to the disease state. Correlations between the state of inflammation and clinicopathological factors as well as the expression status of other analyzed molecules.

+81-11-706-7934

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