UMIN-ICDS Clinical Trial

Public title

Effect of interferential current electrical stimulation of the neck on swallowing function in acute stroke patients

Acronym

IFC-Stroke Study

Scientific Title

Single-arm intervention study on the effect of interferential current electrical stimulation of the neck on swallowing function in acute stroke patients

Scientific Title:Acronym

IFC-Stroke Study

Region

Japan

Condition

Stroke

Classification by specialty

Neurology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To explore the feasibility of continuous application, changes in oral intake status, and changes in the citric acid cough test, which is thought to reflect silent aspiration, following transcutaneous interferential current electrical stimulation of the neck in the acute phase of stroke.

Basic objectives2

Others

Basic objectives -Others

Neurological findings, such as NIHSS, FIM, and FMA, will be collected to compare pre- and post-intervention data.

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Primary outcomes

The proportion of patients who could continue transcutaneous interferential current electrical stimulation of the neck as scheduled until 14 days after the start of intervention (or at the time of discharge) (completion rate)

Key secondary outcomes

Functional Oral Intake Scale (FOIS), 1% citric acid cough test before and after intervention, incidence of hospital-acquired pneumonia, modified Rankin Scale (mRS), National Institutes of Health Stroke Scale (NIHSS), Functional Independence Measure (FIM), and Fugl-Meyer Assessment (FMA).

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Historical

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Transcutaneous interferential current electrical stimulation of the neck

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

1.Patients with acute stroke aged 18 years or older and within 7 days of onset.

2.Patients with a Functional Oral Intake Scale (FOIS) score of 6 or less at the time of obtaining consent.

3.Patients with a Japan Coma Scale (JCS) score of less than 30.

4.Individuals who provide written informed consent for participation in this study, either personally or through a legally authorized representative.

Key exclusion criteria

1.Patients with a history of surgery for neck cancer.

2.Patients with implanted medical devices (e.g., cardiac pacemakers, cochlear implants).

3.Patients with a pulse rate of less than 40 beats per minute.

4.Pregnant or lactating women.

5.Patients judged as inappropriate for participation by the principal investigator.

Target sample size

60

Name of lead principal investigator

1st name	Hirofumi
Middle name
Last name	Maruyama

Organization

Graduate School of Biomedical and Health Sciences, Hiroshima University

Division name

Department of Clinical Neuroscience and Therapeutics

Zip code

734-8551

Address

1-2-3 Kasumi, Minami ward, Hiroshima

TEL

+81-82-257-5201

Email

tomonezu@hiroshima-u.ac.jp

Name of contact person

1st name	Tomohisa
Middle name
Last name	Nezu

Organization

Graduate School of Biomedical and Health Sciences, Hiroshima University

Division name

Department of Clinical Neuroscience and Therapeutics

Zip code

734-8551

Address

1-2-3 Kasumi, Minami ward, Hiroshima

TEL

+81-82-257-5201

Homepage URL

Email

tomonezu@hiroshima-u.ac.jp

Institute

Graduate School of Biomedical and Health Sciences, Hiroshima University

Institute

Department

Personal name

Organization

Grants-in-Aid for Scientific Research (KAKENHI)

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Ethical Committee for Clinical Research of Hiroshima University

Address

Kasumi 1-2-3 Minami-Ku, Hiroshima

Tel

082-257-1947

Email

iryo-sinsa@office.hiroshima-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2026

Year

05

Month

08

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

2026

Year

04

Month

23

Day

Date of IRB

Anticipated trial start date

2026

Year

07

Month

01

Day

Last follow-up date

2029

Year

04

Month

30

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2026

Year

05

Month

07

Day

Last modified on

2026

Year

05

Month

07

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070248