Peripheral magnetic stimulation during swallowing

JRCT ID: jRCTs042190033

Registered date:31/05/2019

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Patients with dysphagia or normal subjects
• Date of first enrollment: 24/06/2019
• Target sample size: 100
• Study type: Interventional
• Intervention(s): peripheral magnetic stimulation, surface electromyogram, videofluorography, videoendoscopy, manometry

Outcome(s)

• Primary Outcome: Movement of hyoid bone and related muscles during swallowing reflex
• Secondary Outcome: Timing of muscle contraction aournd hyoid bone, threshold, pharyngeal pressure, pain during stimulation and mucle pain by using NRS. Moreover, muscle force around hyoid bone, tongue pressure force, FOIS, PAS during videofluorography, dysphagia severity scale, and meal and posture during eating for patients with dysphagia

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both
• Include criteria: Normal subjects, and in- and out-patients with dysphagia at Fujita Health University Hospital, Fujita Health University Bantane Hospital, and National Center for Geriatrics and Gerontology
• Exclude criteria: Normal subjects who could not obtain written informed consent. The patients who had unstable condition, could not follow the instruction, a history of epilepsy, with a pacemaker, had magnetic materials near the stimulus site, and a pregnant woman.

Related Information

• Primary Sponsor: Kagaya Hitoshi
• Source(s) of Monetary Support: Terumo Life Science Foundation