Tokyo, Dec. 5 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059978) titled 'Verification of the Effect of Oral Stimulation Duration via Ice Massage on Activation of Brain Regions Related to Swallowing' on Dec. 5.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - Gunma Univesity
Condition:
Condition - dysphagia
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - We will investigate whether the duration of oral stimulation via ice massage affects the activation of swallowing function and swallowing-related brain regions (VLPFC: ventrolateral prefrontal cortex and DLPFC: dorsolateral prefrontal cortex) using fNIRS.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Intraoral ice massage using an intraoral cooling device (Ice Stick)
Eligibility:
Age-lower limit - 18
years-old
Gender - Male and Female
Key inclusion criteria - Adults aged 18 to 60 inclusive who consented to participate in this study
Key exclusion criteria - A history of cerebral infarction or head and neck treatment, or other neurological conditions that may impair swallowing function, either currently present or in the past.
Cognitive impairment that prevents following instructions.
Target Size - 20
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 11 Month 26 Day
Date of IRB - 2025 Year 11 Month 26 Day
Anticipated trial start date - 2025 Year 12 Month 08 Day
Last follow-up date - 2028 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068609
Disclaimer: Curated by HT Syndication.
