NCT05453019

Effects of CI on Tinnitus and Its Symptoms

Recruiting now NA Last updated 6 June 2023

What this trial tests

NA trial testing Cochlear Implant in Tinnitus in 200 participants. Currently enrolling.

Timeline

4 July 2022

Primary endpoint
1 July 2027

1 July 2027

Quick facts

Lead sponsor	Chinese PLA General Hospital
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	200
Start date	4 July 2022
Primary completion	1 July 2027
Estimated completion	1 July 2027
Sites	1 location across China

Drugs / interventions tested

• Cochlear Implant

Conditions studied

• Tinnitus — all drugs for Tinnitus →

Sponsor

Chinese PLA General Hospital

Who can join

Adults 16 to 90, any sex, with Tinnitus. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.