UMIN-ICDS Clinical Trial

Public title

Innovative Approaches to Inflammatory Arthritis: Efficacy and Safety of non-invasive transcutaneous auricular vagus nerve stimulation (IA-taVNS)

Acronym

IA-taVNS

Scientific Title

Innovative Approaches to Inflammatory Arthritis: Efficacy and Safety of non-invasive transcutaneous auricular vagus nerve stimulation (IA-taVNS)

Scientific Title:Acronym

IA-taVNS

Region

Japan

Condition

Rheumatoid arthritis, Spondyloarthritis

Classification by specialty

Clinical immunology

Classification by malignancy

Others

Genomic information

YES

Narrative objectives1

In this study, we evaluated the effectiveness of non-invasive low-frequency therapy devices, which are covered by insurance for the treatment of painful diseases, on patients with rheumatoid arthritis and spondyloarthritis requiring biological therapy. The goal was symptom relief through the treatment, assessing the improvement of disease activity including inflammation, safety, and the occurrence of adverse events. Through this research, we aimed to assess the applicability of low-frequency treatment for arthritis and explore its potential for clinical application.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Others

Developmental phase

Phase IV

Primary outcomes

Evaluation of Disease Activity Before and After the Use of Low-Frequency Therapy Device:
Number of swollen/painful joints (before and after treatment)
NRS/VAS (Numeric Rating Scale/Visual Analog Scale) (before and after treatment)
CDAI/SDAI (Clinical Disease Activity Index/Simplified Disease Activity Index) (before and after treatment)
ASDAS/BASDAI/BASFI (Ankylosing Spondylitis Disease Activity Score/Bath Ankylosing Spondylitis Disease Activity Index/Bath Ankylosing Spondylitis Functional Index) (before and after treatment)

Key secondary outcomes

Comparison before and after use in patients with inflammatory arthritis
Localization of immune cells before and after the use of a low-frequency therapy device
Expression intensity of a group of molecules induced by IL-6 amplification before and after the use of a low-frequency therapy device
Evaluation criteria for low-frequency therapy in patients with inflammatory arthritis
Correlation of clinical and pathological factors before and after the use of a low-frequency therapy device
Presence of disease-related genetic variants and their association with the disease state
Correlation between the state of IL-6 amp activation and the changes after treatment in the group defined as responsive to low-frequency therapy (defined as an improvement of 20% or more in SDAI or ASDAS) and the non-responsive group
Presence of adverse events during the use of a low-frequency therapy device (electrical reactions such as headaches, fatigue, itching)

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Conduct treatment with a low-frequency therapy device(JMDN code: 35372000, https://www.std.pmda.go.jp/scripts/stdDB/JMDN/stdDB_jmdn_resr.cgi?Sig=1&Select=1&jmdn_no=2867&kjn_no=10123)

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

18

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Individuals who were 18 years or older at the time of consent.
Individuals determined by their primary physician to require treatment with biological agents (patients with rheumatoid arthritis or ankylosing spondylitis).
Individuals who consented to use a low-frequency therapy device daily.
Individuals who, after receiving a full explanation regarding participation in this study, demonstrated sufficient understanding and provided written consent to participate based on their own free will.

Key exclusion criteria

Patients will be excluded from the study if they meet any of the following criteria:

Those who have developed acute heart failure, myocardial infarction, pulmonary edema, or acute exacerbation of interstitial pneumonia within the past 3 months.
Those with a history of progressive cerebral lesions.
Those undergoing vagus nerve stimulation therapy.
Those with a history of epilepsy.
Those with a history of severe cardiovascular disease.
Those with pneumothorax.
Those with uncontrollable infections.
Those who are pregnant or breastfeeding.
Those with a history of skin hypersensitivity and skin reactions to metals or other materials.
Those who have difficulty with oral intake.
Those with severe renal impairment (estimated glomerular filtration rate (eGFR) less than 30ml/min).
Those using a cardiac pacemaker or implantable cardioverter-defibrillator.
Those already using a low-frequency therapy device.
Others who the principal investigator or co-investigator deems inappropriate as study subjects.

Target sample size

20

Name of lead principal investigator

1st name	Yuichiro
Middle name
Last name	Fujieda

Organization

Hokkaido University Hospital

Division name

Rheumatology and Nephrlogy

Zip code

060-8638

Address

N15 W7, Sapporo

TEL

0117065915

Email

edaichi@med.hokudai.ac.jp

Name of contact person

1st name	Yuichiro
Middle name
Last name	Fujieda

Organization

Hokkaido University Hospital

Division name

Rheumatology and Nephrology

Zip code

060-8638

Address

N15 W7, Sapporo

TEL

0117065915

Homepage URL

Email

edaichi@med.hokudai.ac.jp

Institute

Hokkaido University

Institute

Department

Personal name

Organization

Japan Agency for Medical Research and Development

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Ethical Review Board for Life Science and Medical Research, Hokkaido University Hospital

Address

Kita 14, Nishi 5, Kita-ku, Sapporo, Hokkaido, 060-8648, Japan

Tel

011-706-7636

Email

crjimu@huhp.hokudai.ac.jp

Secondary IDs

YES

Study ID_1

023-0119

Org. issuing International ID_1

023-0119

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

北海道大学病院

Date of disclosure of the study information

2024

Year

02

Month

19

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Preinitiation

Date of protocol fixation

2023

Year

12

Month

12

Day

Date of IRB

Anticipated trial start date

2024

Year

02

Month

26

Day

Last follow-up date

2025

Year

12

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2024

Year

02

Month

19

Day

Last modified on

2024

Year

02

Month

20

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061124