The Effect of Middle Ear Pressure on Mild Cognitive Impairment

JRCT ID: jRCTs032240221

Registered date:19/07/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Alzheimer's Disease
• Date of first enrollment: 05/11/2024
• Target sample size: 20
• Study type: Interventional
• Intervention(s): Vestibular stimulation using middle ear pressure

Outcome(s)

• Primary Outcome: Evaluation the change rate of perimeter area (closed eye/soft surface (foam rubber)) in the Stabilometry. The perimeter area before stimulation is used as the baseline, and a change rate of 0% or less 6 months after stimulation is considered effective. If more than 50% of the total is judged to be effective, it is determined to have had an effect.

Key inclusion & exclusion criteria

• Age minimum: >= 50age old
• Age maximum: < 90age old
• Gender: Both

Include criteria

1) Patients with Alzheimer's disease who regularly visit the Department of Neurology at the University of Tsukuba Hospital and have findings suggesting amyloid beta pathology confirmed by amyloid PET or cerebrospinal fluid examination
2) Age at the time of consent acquisition of 50 to 90 years
3) Score of 22 or more on the MMSE dementia test
4) Ability to walk independently and with a severity classification of 1 or more for balance disorders and daily life disorders
5) Patients who have received sufficient explanation for participating in this trial, fully understznd, and have given written consent by thier own free will
6) Consent obtained from the family after explanation and with sufficient understanding

Exclude criteria

1)Patients with paralysis, ataxia, or extrapyramidal symptoms, regardless of the cause
2)Patients with a history of middle or inner ear diseases
3)Patients with external ear canal damage, cerumen impaction, and tympanic membrane perforation
4)Patients using a cardiac pacemaker or implantable defibrillator
5)Other patients whom the physician research (participating) responsible research has judged to be inappropriate as subjects

Related Information

• Primary Sponsor: Nakamagoe Kiyotaka
• Source(s) of Monetary Support: Japan Society for the Promotion of Science,University of Tsukuba Hospital