Establishment of swallowing rehabilitation method using direct brainstem stimulation

JRCT ID: jRCTs042230080

Registered date:15/09/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: medullary infarction
• Date of first enrollment: 29/09/2023
• Target sample size: 20
• Study type: Interventional
• Intervention(s): transcranial electrical stimulation

Outcome(s)

• Primary Outcome: Food Intake LEVEL Scale

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
• 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
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development