Clinical trial NCT05453019: Effects of CI on Tinnitus and Its Symptoms
Official title: Effects of Cochlear Implantation on Tinnitus and Its Symptoms
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tinnitus
Keywords: tinnitus
electrical stimulation
cochlear implant
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2022-07-12
Enrollment: 200
Sex: ALL
Minimum age (years): 16
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 1. Research content 1.1 Study on the change law of tinnitus affected by electrical stimulation after electrode implantation: 1) The change of tinnitus before operation after cochlear implantation; 2) Long term observation of electrical stimulation after cochlear implantation: (1) The change rule of tinnitus loudness after electrical stimulation (how long can it recover to be stable after power on); (2) The regularity of tinnitus frequency after electrical stimulation; (3) The recovery of tinnitus after electrode implantation for various causes of deafness.

   1.2 Study on the mechanism of electric stimulation inhibiting tinnitus: 1) Changes of resting EEG in patients with tinnitus before surgery, before surgery-after surgery, 1 month, 2 months, 3 months, 6 months, 12 month, more than 12 months; 2) The compilation of resting electroencephalogram analysis program; 3) The resting brain wave shape was analyzed to trace the anatomical position of the artificial cochlea to inhibit tinnitus.

   1.3 Study on the optimal setting of electrode stimulation for tinnitus treatment: 1) Setting different electric stimulation frequency and stimulation rate parameters to mask tinnitus; 2) Set the procedure of electric stimulation cochlear implant to mask tinnitus.
2. Research objectives 1) Summarize the changes of tinnitus after electrode implantation (effective treatment time, diseases suitable for electrical stimulation treatment, etc.); 2) Infer the mechanism of electric stimulation inhibiting tinnitus; 3) Set electrical stimulation parameters to effectively suppress tinnitus.
3. Scientific problems to be solved Our study group plan to use more advanced EEG technology to explore the principle of electric stimulation to suppress tinnitus, find out the effective scheme of electric stimulation to treat tinnitus, and help more patients solve the problem of tinnitus.

Eligibility criteria: Inclusion Criteria:

* 1. This study included patients who received cochlear implants at the Auditory Implant Center of the Otorhinolaryngology-Head and Neck Surgery, China PLA General Hospital;
* 2. The patients ranged from 16 to 90 years old;
* 3. 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;
* 4. The cochlear implants accepted by patients included products from MED-EL, Cochlear, Advanced Bionics and Nurotron;
* 5. All patients voluntarily participated in the study.

Exclusion Criteria:

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

Primary outcomes:
measure: Electrical stimulation channel number
timeFrame: 1 week after operation
measure: Electrical stimulation channel number
timeFrame: 1 month after operation
measure: Electrical stimulation channel number
timeFrame: 2 months after operation
measure: Electrical stimulation channel number
timeFrame: 3 months after CI operation
measure: Electrical stimulation channel number
timeFrame: 4 months after operation
measure: Electrical stimulation channel number
timeFrame: 7 months after operation
measure: Electrical stimulation channel number
timeFrame: 13 months after operation
measure: Electrical stimulation channel number
timeFrame: over 13 months after operation
measure: Tinnitus characteristic information questionnaire
timeFrame: Pre-operation
measure: Tinnitus characteristic information questionnaire
timeFrame: 1 week after operation
measure: Tinnitus characteristic information questionnaire
timeFrame: 1 month after operation
measure: Tinnitus characteristic information questionnaire
timeFrame: 2 months after operation
measure: Tinnitus characteristic information questionnaire
timeFrame: 3 months after operation
measure: Tinnitus characteristic information questionnaire
timeFrame: 4 months after operation
measure: Tinnitus characteristic information questionnaire
timeFrame: 7 months after operation
measure: Tinnitus characteristic information questionnaire
timeFrame: 13 months after operation
measure: Tinnitus characteristic information questionnaire
timeFrame: over 13 months after operation
measure: Tinnitus loudness(CI electrical stimulation intensity)
timeFrame: 1 week after operation
measure: Tinnitus loudness(CI electrical stimulation intensity)
timeFrame: 1 month after operation
measure: Tinnitus loudness(CI electrical stimulation intensity)
timeFrame: 2 months after operation
measure: Tinnitus loudness(CI electrical stimulation intensity)
timeFrame: 3 months after operation
measure: Tinnitus loudness(CI electrical stimulation intensity)
timeFrame: 4 months after operation
measure: Tinnitus loudness(CI electrical stimulation intensity)
timeFrame: 7 months after operation
measure: Tinnitus loudness(CI electrical stimulation intensity)
timeFrame: 13 months after operation
measure: Tinnitus loudness(CI electrical stimulation intensity)
timeFrame: over 13 months after operation
measure: Objective electroencephalography-based assessment(EEG)
timeFrame: Pre-operation
measure: Objective electroencephalography-based assessment(EEG)
timeFrame: 1 week after operation
measure: Objective electroencephalography-based assessment(EEG)
timeFrame: 1 month after operation
measure: Objective electroencephalography-based assessment(EEG)
timeFrame: 2 months after operation
measure: Objective electroencephalography-based assessment(EEG)
timeFrame: 3 months after operation
measure: Objective electroencephalography-based assessment(EEG)
timeFrame: 4 months after operation
measure: Objective electroencephalography-based assessment(EEG)
timeFrame: 7 months after operation
measure: Objective electroencephalography-based assessment(EEG)
timeFrame: 13 months after operation
measure: Objective electroencephalography-based assessment(EEG)
timeFrame: over 13 months after operation
measure: Speech perception
timeFrame: Pre-operation
measure: Speech perception
timeFrame: 1 months after operation
measure: Speech perception
timeFrame: 2 month after operation
measure: Speech perception
timeFrame: 4 months after operation
measure: Speech perception
timeFrame: 7 months after operation
measure: Speech perception
timeFrame: 13 months after CI operation
measure: Speech perception
timeFrame: over 13 months after CI activation
Secondary outcomes:
measure: Pure tone test
timeFrame: pre-operation
measure: Pure tone test
timeFrame: 1 month after operation
measure: Pure tone test
timeFrame: 2 months after operation
measure: Pure tone test
timeFrame: 4 months after operation
measure: Pure tone test
timeFrame: 7 month after operation
measure: Pure tone test
timeFrame: 13 month after operation
measure: Pure tone test
timeFrame: over 13 month after operation
measure: Self-Rating Anxiety Scale (SAS) questionnaire
timeFrame: Pre-operation
measure: Self-Rating Anxiety Scale (SAS) questionnaire
timeFrame: 1 month after operation
measure: Self-Rating Anxiety Scale (SAS) questionnaire
timeFrame: 2 months after operation
measure: Self-Rating Anxiety Scale (SAS) questionnaire
timeFrame: 4 months after operation
measure: Self-Rating Anxiety Scale (SAS) questionnaire
timeFrame: 7 months after operation
measure: Self-Rating Anxiety Scale (SAS) questionnaire
timeFrame: 13 months after operation
measure: Self-Rating Anxiety Scale (SAS) questionnaire
timeFrame: over 13 months after operation
Other outcomes:
Locations:
city: Beijing
country: China
facility: Qian Wang
state: France
Study officials:
affiliation: Chinese PLA General Hospital
name: Shi m Yang, M.D., Ph.D.
role: STUDY_DIRECTOR
References: