Tokyo, May 8 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061480) titled 'Effect of interferential current electrical stimulation of the neck on swallowing function in acute stroke patients' on May 8.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Historical
Primary Sponsor:
Institute - Graduate School of Biomedical and Health Sciences, Hiroshima University
Condition:
Condition - Stroke
Classification by malignancy - Others
Genomic information - NO
Objective:
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
Intervention:
Interventions/Control_1 - Transcutaneous interferential current electrical stimulation of the neck
Eligibility:
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 Size - 60
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 04 Month 23 Day
Anticipated trial start date - 2026 Year 07 Month 01 Day
Last follow-up date - 2029 Year 04 Month 30 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070248
Disclaimer: Curated by HT Syndication.