JRCT ID: jRCTs042230080
Registered date:15/09/2023
Establishment of swallowing rehabilitation method using direct brainstem stimulation
Basic Information
Recruitment status | Recruiting |
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Health condition(s) or Problem(s) studied | medullary infarction |
Date of first enrollment | 29/09/2023 |
Target sample size | 20 |
Countries of recruitment | |
Study type | Interventional |
Intervention(s) | transcranial electrical stimulation |
Outcome(s)
Primary Outcome | Food Intake LEVEL Scale |
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Secondary Outcome | Swallowing endoscopy Hyodo score Swallowing angiography Oral transit time, pharyngeal transit time, time to elicit swallowing reflex, and distance of hyoid bone movement The Mann Assessment of Swallowing Ability (MASA) |
Key inclusion & exclusion criteria
Age minimum | >= 18age old |
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Age maximum | <= 75age old |
Gender | Both |
Include criteria | 1.Men and women between the ages of 18 and 75 2.Patients with medullary infarction with dysphagia 3.Patients must have a MASA dysphagia score of 167 or less and MASA aspiration score of 148 or less as assessed by the Mann Assessment of Swallowing Ability (MASA), a disability evaluation method 4.Patients who have obtained written consent for participation in this study from the patient or the patient's surrogate. |
Exclude criteria | 1.Patients with a cardiac pacemaker 2.Patients with metal clips or other metal objects in the cranium 3.Patients with an indwelling catheter in the heart 4.Patients with obvious intracranial hypertension 5.Patients with metals that cannot be confirmed to be non-magnetic (e.g., nerve stimulators, insulin pumps, stents, intraocular metals, etc.) in the body 6.Patients with significant hearing impairment and inability to communicate 7.Women whose pregnancy cannot be ruled out 8.Patients with a family history of epilepsy 9.Other cases deemed inappropriate by the principal/assistant investigator |
Related Information
Primary Sponsor | Aoyama Kiminori |
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Secondary Sponsor | |
Source(s) of Monetary Support | Japan Agency for Medical Research and Development |
Secondary ID(s) |
Contact
Public contact | |
Name | Kiminori Aoyama |
Address | 1-2-23 Wakamizu, Chikusa-ku, Nagoya-shi, Aichi Aichi Japan 464-8547 |
Telephone | +81-52-721-7171 |
kiminori@med.nagoya-cu.ac.jp | |
Affiliation | Nagoya City University East Medical Center |
Scientific contact | |
Name | Kiminori Aoyama |
Address | 1-2-23 Wakamizu, Chikusa-ku, Nagoya-shi, Aichi Aichi Japan 464-8547 |
Telephone | +81-52-721-7171 |
kiminori@med.nagoya-cu.ac.jp | |
Affiliation | Nagoya City University East Medical Center |