Elucidation of the mechanism of action of low-frequency therapy.

JRCT ID: jRCT1012230046

Registered date:11/11/2023

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Healthy human
• Date of first enrollment: 11/11/2023
• Target sample size: 50
• Study type: Interventional
• Intervention(s): Perform stimulation with a low-frequency therapy device. During stimulation, avoid splashing water on the body and electrodes, and allow walking and moving around, but only to the extent that the electrodes are not displaced. During stimulation, toileting, eating and sleeping are permitted and there are no restrictions on behaviour or posture. Stimulation is performed for 1 hour (1 hour and 20 minutes including the MRI) using 1.5 mA, 25 Hz, 250 us as the standard, but as habituation may occur, the stimulation should be performed at 1-20 mA, 2-100 Hz with a target of 37 crackling but no pain. The research assistant will check and make adjustments between 1 and 20 mA, 2 and 100 Hz.

Outcome(s)

• Primary Outcome: Comparison of the degree of T cell activation by anti-CD3/CD28 antibodies before and after stimulation.

Secondary Outcome

1. comparison with previous reports in patients with diseases related to the activation state of immune cells (rheumatoid arthritis, inflammatory bowel syndrome, knee osteoarthritis, interstitial pneumonia, epilepsy)
2. comparison with samples from patients with diseases regarding the expression positivity and intensity of a group of molecules whose expression is induced by low-frequency stimulation
3. comparison with previous reports on disease-related gene variants in patients with disease
4. correlation between brain activity data in MRI and expression of various analysed molecules

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Both

Include criteria

(i) Persons aged 18 years or over at the time of obtaining consent.
(ii) Persons who do not have rheumatoid arthritis, spondyloarthritis, osteoarthritis or interstitial pneumonia
(iii) Persons who understand the purpose of the study and have given their free and voluntary written consent to participate.

Exclude criteria

(i) Those who have developed acute heart failure, myocardial infarction, pulmonary oedema or acute exacerbation of interstitial pneumonia within the past 3 months.
(ii) Those with a history of cerebral or central nervous system lesions
(iii) Those receiving concomitant vagus nerve stimulation therapy
(iv) Those with a history of epilepsy
(v) Those with a history of severe cardiovascular disease
(vi) Persons with pneumothorax
(vii) Persons with uncontrolled infections
(viii) Pregnant or lactating women
(ix) Persons with skin hypersensitivity and a history of skin symptoms caused by metal or other substances.
(x) Persons with difficulty in oral intake.
(xi) Those with severe renal dysfunction (estimated glomerular filtration rate (eGFR) < 30 ml/min).
(xiii) Persons with a cardiac pacemaker or implantable cardioverter-defibrillator.
Persons who are ineligible to participate in the study on the attached 'MRI Questionnaire'.
(iv) Other subjects who are deemed inappropriate as research subjects by the Principal Investigator or the Research Assigning Physician.

Related Information

• Primary Sponsor: Satoshi Konnno