Effects of CI on Tinnitus and Its Symptoms

Study Overview
=================
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
-----------------
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. 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. 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.

Official Title
-----------------
Effects of Cochlear Implantation on Tinnitus and Its Symptoms

Conditions
-----------------
Tinnitus

Intervention / Treatment
-----------------
* Device: Cochlear Implant


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: tinnitus group<br>Patients who have tinnitus got cochlear implant | Device: Cochlear Implant<br>* 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.<br>|
| Active Comparator: without tinnitus group<br>Patients who have no tinnitus got cochlear implant | Device: Cochlear Implant<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Electrical stimulation channel number | Stimulating basement membrane with cochlear implant electrode to match tinnitus frequency. The cochlear implant electrode number is recorded. | 1 week after operation | 
| Electrical stimulation channel number | frequency. The cochlear implant electrode number is recorded. | 1 month after operation | 
| Electrical stimulation channel number | frequency. The cochlear implant electrode number is recorded. | 2 months after operation | 
| Electrical stimulation channel number | frequency. The cochlear implant electrode number is recorded. | 3 months after CI operation | 
| Electrical stimulation channel number | frequency. The cochlear implant electrode number is recorded. | 4 months after operation | 
| Electrical stimulation channel number | frequency. The cochlear implant electrode number is recorded. | 7 months after operation | 
| Electrical stimulation channel number | frequency. The cochlear implant electrode number is recorded. | 13 months after operation | 
| Electrical stimulation channel number | frequency. The cochlear implant electrode number is recorded. | over 13 months after operation | 
| Tinnitus characteristic information questionnaire | A multifactorial and closed-ended questionnaire was developed by our CI center. The demographics and part of the tinnitus descriptions were recorded in Tinnitus Characteristics questionnaire for CI recipients. The patients' basic information, such as gender, age, aetiology, CI side, CI type, and time of deafness was completed by patients. Tinnitus characteristics information, including localization, duration, and type was collected for correlation analysis. | Pre-operation | 
| Tinnitus characteristic information questionnaire | A multifactorial and closed-ended questionnaire was developed by our CI center. The demographics and part of the tinnitus descriptions were recorded in Tinnitus Characteristics questionnaire for CI recipients. The patients' basic information, such as gender, age, aetiology, CI side, CI type, and time of deafness was completed by patients. Tinnitus characteristics information, including localization, duration, and type was collected for correlation analysis. | 1 week after operation | 
| Tinnitus characteristic information questionnaire | A multifactorial and closed-ended questionnaire was developed by our CI center. The demographics and part of the tinnitus descriptions were recorded in Tinnitus Characteristics questionnaire for CI recipients. The patients' basic information, such as gender, age, aetiology, CI side, CI type, and time of deafness was completed by patients. Tinnitus characteristics information, including localization, duration, and type was collected for correlation analysis. | 1 month after operation | 
| Tinnitus characteristic information questionnaire | A multifactorial and closed-ended questionnaire was developed by our CI center. The demographics and part of the tinnitus descriptions were recorded in Tinnitus Characteristics questionnaire for CI recipients. The patients' basic information, such as gender, age, aetiology, CI side, CI type, and time of deafness was completed by patients. Tinnitus characteristics information, including localization, duration, and type was collected for correlation analysis. | 2 months after operation | 
| Tinnitus characteristic information questionnaire | A multifactorial and closed-ended questionnaire was developed by our CI center. The demographics and part of the tinnitus descriptions were recorded in Tinnitus Characteristics questionnaire for CI recipients. The patients' basic information, such as gender, age, aetiology, CI side, CI type, and time of deafness was completed by patients. Tinnitus characteristics information, including localization, duration, and type was collected for correlation analysis. | 3 months after operation | 
| Tinnitus characteristic information questionnaire | A multifactorial and closed-ended questionnaire was developed by our CI center. The demographics and part of the tinnitus descriptions were recorded in Tinnitus Characteristics questionnaire for CI recipients. The patients' basic information, such as gender, age, aetiology, CI side, CI type, and time of deafness was completed by patients. Tinnitus characteristics information, including localization, duration, and type was collected for correlation analysis. | 4 months after operation | 
| Tinnitus characteristic information questionnaire | A multifactorial and closed-ended questionnaire was developed by our CI center. The demographics and part of the tinnitus descriptions were recorded in Tinnitus Characteristics questionnaire for CI recipients. The patients' basic information, such as gender, age, aetiology, CI side, CI type, and time of deafness was completed by patients. Tinnitus characteristics information, including localization, duration, and type was collected for correlation analysis. | 7 months after operation | 
| Tinnitus characteristic information questionnaire | A multifactorial and closed-ended questionnaire was developed by our CI center. The demographics and part of the tinnitus descriptions were recorded in Tinnitus Characteristics questionnaire for CI recipients. The patients' basic information, such as gender, age, aetiology, CI side, CI type, and time of deafness was completed by patients. Tinnitus characteristics information, including localization, duration, and type was collected for correlation analysis. | 13 months after operation | 
| Tinnitus characteristic information questionnaire | A multifactorial and closed-ended questionnaire was developed by our CI center. The demographics and part of the tinnitus descriptions were recorded in Tinnitus Characteristics questionnaire for CI recipients. The patients' basic information, such as gender, age, aetiology, CI side, CI type, and time of deafness was completed by patients. Tinnitus characteristics information, including localization, duration, and type was collected for correlation analysis. | over 13 months after operation | 
| Tinnitus loudness(CI electrical stimulation intensity) | The tinnitus loudness was matched by the stimulation current level of cochlear implant electrode, The ultimate electrode stimulation current (IµA) is quantified in µA and the tinnitus loudness is recorded in Qtin (nC, 10-9C) (i.e. Qtin=IµA* tp). | 1 week after operation | 
| Tinnitus loudness(CI electrical stimulation intensity) | The tinnitus loudness was matched by the stimulation current level of cochlear implant electrode, The ultimate electrode stimulation current (IµA) is quantified in µA and the tinnitus loudness is recorded in Qtin (nC, 10-9C) (i.e. Qtin=IµA* tp). | 1 month after operation | 
| Tinnitus loudness(CI electrical stimulation intensity) | The tinnitus loudness was matched by the stimulation current level of cochlear implant electrode, The ultimate electrode stimulation current (IµA) is quantified in µA and the tinnitus loudness is recorded in Qtin (nC, 10-9C) (i.e. Qtin=IµA* tp). | 2 months after operation | 
| Tinnitus loudness(CI electrical stimulation intensity) | The tinnitus loudness was matched by the stimulation current level of cochlear implant electrode, The ultimate electrode stimulation current (IµA) is quantified in µA and the tinnitus loudness is recorded in Qtin (nC, 10-9C) (i.e. Qtin=IµA* tp). | 3 months after operation | 
| Tinnitus loudness(CI electrical stimulation intensity) | The tinnitus loudness was matched by the stimulation current level of cochlear implant electrode, The ultimate electrode stimulation current (IµA) is quantified in µA and the tinnitus loudness is recorded in Qtin (nC, 10-9C) (i.e. Qtin=IµA* tp). | 4 months after operation | 
| Tinnitus loudness(CI electrical stimulation intensity) | The tinnitus loudness was matched by the stimulation current level of cochlear implant electrode, The ultimate electrode stimulation current (IµA) is quantified in µA and the tinnitus loudness is recorded in Qtin (nC, 10-9C) (i.e. Qtin=IµA* tp). | 7 months after operation | 
| Tinnitus loudness(CI electrical stimulation intensity) | The tinnitus loudness was matched by the stimulation current level of cochlear implant electrode, The ultimate electrode stimulation current (IµA) is quantified in µA and the tinnitus loudness is recorded in Qtin (nC, 10-9C) (i.e. Qtin=IµA* tp). | 13 months after operation | 
| Tinnitus loudness(CI electrical stimulation intensity) | The tinnitus loudness was matched by the stimulation current level of cochlear implant electrode, The ultimate electrode stimulation current (IµA) is quantified in µA and the tinnitus loudness is recorded in Qtin (nC, 10-9C) (i.e. Qtin=IµA* tp). | over 13 months after operation | 
| Objective electroencephalography-based assessment(EEG) | EEG is a non-invasive objective assessment technique that records brain activity along with specific neural pathways. we utilize cortical auditory evoked potential (CAEP) and event-related potentials(ERP) to obtain time-domain analysis. | Pre-operation | 
| Objective electroencephalography-based assessment(EEG) | The EEG waveforms of CI patients were tested, and the amplitude and latency were recorded. | 1 week after operation | 
| Objective electroencephalography-based assessment(EEG) | EEG is a non-invasive objective assessment technique that records brain activity along with specific neural pathways. we utilize cortical auditory evoked potential (CAEP) and event-related potentials(ERP) to obtain time-domain analysis. | 1 month after operation | 
| Objective electroencephalography-based assessment(EEG) | EEG is a non-invasive objective assessment technique that records brain activity along with specific neural pathways. we utilize cortical auditory evoked potential (CAEP) and event-related potentials(ERP) to obtain time-domain analysis. | 2 months after operation | 
| Objective electroencephalography-based assessment(EEG) | EEG is a non-invasive objective assessment technique that records brain activity along with specific neural pathways. we utilize cortical auditory evoked potential (CAEP) and event-related potentials(ERP) to obtain time-domain analysis. | 3 months after operation | 
| Objective electroencephalography-based assessment(EEG) | EEG is a non-invasive objective assessment technique that records brain activity along with specific neural pathways. we utilize cortical auditory evoked potential (CAEP) and event-related potentials(ERP) to obtain time-domain analysis. | 4 months after operation | 
| Objective electroencephalography-based assessment(EEG) | EEG is a non-invasive objective assessment technique that records brain activity along with specific neural pathways. we utilize cortical auditory evoked potential (CAEP) and event-related potentials(ERP) to obtain time-domain analysis. | 7 months after operation | 
| Objective electroencephalography-based assessment(EEG) | EEG is a non-invasive objective assessment technique that records brain activity along with specific neural pathways. we utilize cortical auditory evoked potential (CAEP) and event-related potentials(ERP) to obtain time-domain analysis. | 13 months after operation | 
| Objective electroencephalography-based assessment(EEG) | EEG is a non-invasive objective assessment technique that records brain activity along with specific neural pathways. we utilize cortical auditory evoked potential (CAEP) and event-related potentials(ERP) to obtain time-domain analysis. | over 13 months after operation | 
| Speech perception | The patient are tested for speech recognition and the results were recorded as a percentage | Pre-operation | 
| Speech perception | The patient are tested for speech recognition and the results were recorded as a percentage | 1 months after operation | 
| Speech perception | The patient are tested for speech recognition and the results were recorded as a percentage | 2 month after operation | 
| Speech perception | The patient are tested for speech recognition and the results were recorded as a percentage | 4 months after operation | 
| Speech perception | The patient are tested for speech recognition and the results were recorded as a percentage | 7 months after operation | 
| Speech perception | The patient are tested for speech recognition and the results were recorded as a percentage | 13 months after CI operation | 
| Speech perception | The patient are tested for speech recognition and the results were recorded as a percentage | over 13 months after CI activation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pure tone test | Evaluation of 250-8000hz hearing effect in patients with hearing loss | pre-operation | 
| Pure tone test | Evaluation of 250-8000hz hearing effect in patients with hearing loss | 1 month after operation | 
| Pure tone test | Evaluation of 250-8000hz hearing effect in patients with hearing loss | 2 months after operation | 
| Pure tone test | Evaluation of 250-8000hz hearing effect in patients with hearing loss | 4 months after operation | 
| Pure tone test | Evaluation of 250-8000hz hearing effect in patients with hearing loss | 7 month after operation | 
| Pure tone test | Evaluation of 250-8000hz hearing effect in patients with hearing loss | 13 month after operation | 
| Pure tone test | Evaluation of 250-8000hz hearing effect in patients with hearing loss | over 13 month after operation | 
| Self-Rating Anxiety Scale (SAS) questionnaire | Assessment of patients' mental state （depression, anxiety, insomnia），The result analysis chart of this system shows the standard score. The higher the score, the more serious the symptoms in this regard. Generally speaking, those whose total anxiety score is less than 50 are normal; 50-60 is mild, 61-70 is moderate, and more than 70 is severe anxiety. The number of negative items means the number of items on which the subject did not respond, and the number of positive items means the number of items on which the subject responded. Total rough score: the scores of 20 items are added together, and the demarcation score is 40 points. | Pre-operation | 
| Self-Rating Anxiety Scale (SAS) questionnaire | Assessment of patients' mental state （depression, anxiety, insomnia），The result analysis chart of this system shows the standard score. The higher the score, the more serious the symptoms in this regard. Generally speaking, those whose total anxiety score is less than 50 are normal; 50-60 is mild, 61-70 is moderate, and more than 70 is severe anxiety. The number of negative items means the number of items on which the subject did not respond, and the number of positive items means the number of items on which the subject responded. Total rough score: the scores of 20 items are added together, and the demarcation score is 40 points. | 1 month after operation | 
| Self-Rating Anxiety Scale (SAS) questionnaire | Assessment of patients' mental state （depression, anxiety, insomnia），The result analysis chart of this system shows the standard score. The higher the score, the more serious the symptoms in this regard. Generally speaking, those whose total anxiety score is less than 50 are normal; 50-60 is mild, 61-70 is moderate, and more than 70 is severe anxiety. The number of negative items means the number of items on which the subject did not respond, and the number of positive items means the number of items on which the subject responded. Total rough score: the scores of 20 items are added together, and the demarcation score is 40 points. | 2 months after operation | 
| Self-Rating Anxiety Scale (SAS) questionnaire | Assessment of patients' mental state （depression, anxiety, insomnia），The result analysis chart of this system shows the standard score. The higher the score, the more serious the symptoms in this regard. Generally speaking, those whose total anxiety score is less than 50 are normal; 50-60 is mild, 61-70 is moderate, and more than 70 is severe anxiety. The number of negative items means the number of items on which the subject did not respond, and the number of positive items means the number of items on which the subject responded. Total rough score: the scores of 20 items are added together, and the demarcation score is 40 points. | 4 months after operation | 
| Self-Rating Anxiety Scale (SAS) questionnaire | Assessment of patients' mental state （depression, anxiety, insomnia），The result analysis chart of this system shows the standard score. The higher the score, the more serious the symptoms in this regard. Generally speaking, those whose total anxiety score is less than 50 are normal; 50-60 is mild, 61-70 is moderate, and more than 70 is severe anxiety. The number of negative items means the number of items on which the subject did not respond, and the number of positive items means the number of items on which the subject responded. Total rough score: the scores of 20 items are added together, and the demarcation score is 40 points. | 7 months after operation | 
| Self-Rating Anxiety Scale (SAS) questionnaire | Assessment of patients' mental state （depression, anxiety, insomnia），The result analysis chart of this system shows the standard score. The higher the score, the more serious the symptoms in this regard. Generally speaking, those whose total anxiety score is less than 50 are normal; 50-60 is mild, 61-70 is moderate, and more than 70 is severe anxiety. The number of negative items means the number of items on which the subject did not respond, and the number of positive items means the number of items on which the subject responded. Total rough score: the scores of 20 items are added together, and the demarcation score is 40 points. | 13 months after operation | 
| Self-Rating Anxiety Scale (SAS) questionnaire | Assessment of patients' mental state （depression, anxiety, insomnia），The result analysis chart of this system shows the standard score. The higher the score, the more serious the symptoms in this regard. Generally speaking, those whose total anxiety score is less than 50 are normal; 50-60 is mild, 61-70 is moderate, and more than 70 is severe anxiety. The number of negative items means the number of items on which the subject did not respond, and the number of positive items means the number of items on which the subject responded. Total rough score: the scores of 20 items are added together, and the demarcation score is 40 points. | over 13 months after operation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
tinnitus, electrical stimulation, cochlear implant