Meniere’s disease
Conditions
Interventions
Experimental group:Under general anesthesia, the approach behind the ear was adopted, and after the mastoid process was contoured, the three semicircular canals were contoured, and the fine sand drill
Control group:Tympanocentesis on the affected side was performed under local anesthesia, and gentamicin was injected intratympanically. The patient lies flat on the side of the head, the affected ear
2) The subject has dizziness/vertigo, balance disorders, and decreased vHIT gain, e
Sponsors
The Second People's Hospital of Shandong Province (Shandong Otolaryngology Hospital, Shandong Institute of Otolaryngology)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Confirmed unilateral Meniere's disease according to the 2015 Barany diagnostic criteria. i. Two or more spontaneous vertigo episodes, each lasting 20 minutes to 12 hours. ii. At least one audiologically documented low to mid-frequency sensorineural hearing loss (0.5, 1, 2 k Hz) before, during, or after a vertigo episode. iii. Fluctuating auditory symptoms (hearing, tinnitus, or tinnitus) in the affected ear. iv. Other diagnoses that are not better explained. 2. According to previous medical records, after >=6 months of drug treatment, and oral/intravenous hormones >=7 days and/or tympanic injection >=4 times) during the attack period, the vertigo is still poorly controlled, that is, the average number of episodes per month during the treatment period in the 6 months before enrollment>=1, or a total of >=6 episodes in 6 months; 3. PTA in the affected ear shows an average threshold of 0.5, 1,2k Hz for three frequencies PTA>=60dB; The contralateral ear shows normal hearing matched for age; 4. Duration of the disease >=24 months (from the first onset of MD symptoms); 5. 18-70 years old, able to tolerate general anesthesia surgery; 6. Willing to cooperate with the examination and follow-up plan, and willing to sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Evidence of bilateral Meniere's disease; 2.Cerebellopontine angle tumor or other intracranial space-occupying lesions; 3.Other vestibular diseases: Suffering from other central or peripheral vestibular diseases, such as vestibular migraine, benign paroxysmal positional vertigo, and persistent postural-perceptual vertigo; 4.Family history of unexplained deafness; 5.Duration of drug treatment less than 6 months; 6.Allergy to gentamicin; 7.Other concurrent diseases that may interfere with treatment and evaluation, such as active middle ear disease; 8.Age outside the range of 18-70 years old; 9.Inability to tolerate general anesthesia; 10.Pregnant or lactating women: Women who are pregnant, lactating, or planning to become pregnant during the trial period; 11.HIV positive, hepatitis B virus replication phase, unexplained fever; 12.Complicated with confirmed mental illness; 13.Other conditions that do not meet the inclusion criteria, such as unclear cause of vertigo, refusal to participate in the study, etc. 14.Other conditions that the researcher deems unsuitable for participating in the trial;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effective rate of vertigo control; | — |
Secondary
| Measure | Time frame |
|---|---|
| Balance recovery;Vestibular function;Relief of subjective symptoms;Hearing loss;Safety evaluation; | — |
Countries
China
Contacts
Public ContactDaogong Zhang
The Second People's Hospital of Shandong Province (Shandong Otolaryngology Hospital, Shandong Institute of Otolaryngology)
Outcome results
None listed