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The Effect of Middle Ear Pressure on Mild Cognitive Impairment

Examination of the Effect of Vestibular Stimulation by a Non-invasive Middle Ear Pressure Device on Balance Disorders in Mild Cognitive Impairment

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs032240221
Enrollment
20
Registered
2024-07-19
Start date
2024-11-05
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer's Disease

Interventions

Vestibular stimulation using middle ear pressure

Sponsors

Nakamagoe Kiyotaka
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion 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

Design outcomes

Primary

MeasureTime frame
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.

Contacts

Public ContactKiyotaka Nakamagoe

University of Tsukuba Hospital

nakamagoek@md.tsukuba.ac.jp+81-29-853-3224

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026