RecruitingNot ApplicableNCT05453019

Effects of CI on Tinnitus and Its Symptoms

Effects of Cochlear Implantation on Tinnitus and Its Symptoms


Sponsor

Chinese PLA General Hospital

Enrollment

200 participants

Start Date

Jul 4, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

Abnormal activity in the central auditory system is the cause of subjective experience of tinnitus. Electrical stimulation can inhibit the abnormal activity of auditory related neurons in patients with tinnitus. In recent years, the application of electrical stimulation in the treatment of tinnitus is a hot research topic, and has made some progress. However, its treatment is still in the discussion stage, and there is no best scheme suitable for clinical practice. At present, scholars have found that cochlear electrode stimulation can inhibit tinnitus, but its mechanism is not clear. It is difficult to locate the origin of tinnitus, and the location of electrode stimulation and stimulation parameters still need to be further optimized. Because the implanted part of the cochlear implant contains magnets, the patients cannot perform functional MRI. However, the prevalence of tinnitus in this group is very high (67.0\~100.0%, with an average of 80.0%), so it is of great value and significance to study the effect of tinnitus treatment in such patients. In this study, a new clinical electroencephalogram (EEG) technique was used to make up for the lack of MRI imaging in patients with electrode implantation. EEG analyzes the functional connection of different brain regions through EEG test electrodes, uses the traceability function of EEG software to locate the location of tinnitus, analyzes the process of tinnitus inhibition by electrical stimulation, and explains the mechanism of tinnitus inhibition by electrical stimulation from a new perspective.


Eligibility

Min Age: 16 YearsMax Age: 90 Years

Inclusion Criteria5

  • \. This study included patients who received cochlear implants at the Auditory Implant Center of the Otorhinolaryngology-Head and Neck Surgery, China PLA General Hospital;
  • \. The patients ranged from 16 to 90 years old;
  • \. The patient experienced hearing loss and had either tinnitus longer than 0.25 years (experimental group 1) or no tinnitus (control group 2) before the cochlear implant surgery;
  • \. The cochlear implants accepted by patients included products from MED-EL, Cochlear, Advanced Bionics and Nurotron;
  • \. All patients voluntarily participated in the study.

Exclusion Criteria3

  • Tinnitus types exclude non otogenic tinnitus (including tinnitus caused by hypertension, heart disease, hyperthyroidism, neurasthenia, hyperlipidemia, etc.);
  • Contraindications of cochlear implant surgery (refer to the guidelines for cochlear implant 2013 of the Chinese Medical Association);
  • Intellectual deficiency

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Interventions

DEVICECochlear Implant

The surgeon will make a small cut (incision) behind patient's ear, and form a small hole in the portion of skull bone (mastoid) where the internal device rests. Then the surgeon create a small opening in the cochlea in order to thread the electrode of the internal cochlear implant device. The skin incision is stitched closed so that the internal device is under the skin.


Locations(1)

Qian Wang

Beijing, France, China

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NCT05453019


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