Exploratory clinical trial of low-frequency treatment for multiple chemical sensitivity

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT1012250031

Enrollment

Registered

2025-09-16

Start date

2025-09-16

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

multiple chemical sensitivity multiple chemical sensitivity

Interventions

Low-frequency therapy device (Class II) (Ito Ultrashort Wave ESPURGE or PICORINA modified device Clark VN (based on PICORINA, applied for as a low-frequency therapy device and modified to replace need

low-frequency therapy

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with multiple chemical sensitivity who are visiting or hospitalized at Hokkaido University Hospital (Respiratory Medicine), Kinki University Hospital, or Shonan Kamakura General Hospital between the date of implementation and January 31, 2028.

Exclusion criteria

Exclusion criteria: Patients who meet any of the following criteria will be excluded from the study. Those with a history of progressive brain lesions Those undergoing vagus nerve stimulation therapy Those with a history of severe cardiovascular disease Pregnant or breastfeeding women individuals with a history of skin hypersensitivity, such as skin symptoms caused by metals Individuals who have difficulty ingesting orally Individuals using a cardiac pacemaker or implantable defibrillator Other individuals deemed inappropriate as study subjects by the principal investigator or co-investigator Translated with DeepL.com (free version)

Design outcomes

Primary

Measure	Time frame
Changes in QEESI scores between the start of treatment and week 52 with low-frequency therapy (Improvement is defined as a decrease in scores from before treatment)	—

Secondary

Measure	Time frame
Occurrence of adverse events during low-frequency treatment Change in EQ-5D-5L scores between baseline and week 52 before and after low-frequency treatment Occurrence of exacerbation episodes during low-frequency treatment from baseline to week 52 The localization of immune cells, the expression positivity and intensity of molecules induced by inflammation, the presence or absence of disease-related gene variants, and their association with disease status before and after low-frequency therapy. Correlation between the state of inflammation and clinical pathological factors and the expression status of other analyzed molecules.	—

Measure

Time frame

Occurrence of adverse events during low-frequency treatment Change in EQ-5D-5L scores between baseline and week 52 before and after low-frequency treatment Occurrence of exacerbation episodes during low-frequency treatment from baseline to week 52 The localization of immune cells, the expression positivity and intensity of molecules induced by inflammation, the presence or absence of disease-related gene variants, and their association with disease status before and after low-frequency therapy. Correlation between the state of inflammation and clinical pathological factors and the expression status of other analyzed molecules.

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Contacts

Public ContactKojima Yuichi

Hokkaido University Hospital

yu1.kojima@pop.med.hokudai.ac.jp+81-117161161

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026