TinnitusNCT05453019
Effects of CI on Tinnitus and Its Symptoms
A study testing Cochlear Implant in people with Tinnitus, run by Chinese PLA General Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Tinnitus
- What is being tested?
- Cochlear Implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 4 Jul 2022to 1 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 90 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Qian Wang
Beijing, France, 100085
QIAN WANG, +8618211068103, only_elizabeth@126.com
About this study
Official title: Effects of Cochlear Implantation on Tinnitus and Its Symptoms
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.
Read the 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.
- Conditions
- Tinnitus
- Being tested
- Cochlear Implant
- Keywords
- tinnitus, electrical stimulation, cochlear implant
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cochlear ImplantDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| tinnitus group | Experimental | Patients who have tinnitus got cochlear implant Receives: Device: Cochlear Implant |
| without tinnitus group | Active comparator | Patients who have no tinnitus got cochlear implant Receives: Device: Cochlear Implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electrical stimulation channel number
Stimulating basement membrane with cochlear implant electrode to match tinnitus frequency. The cochlear implant electrode number is recorded.
Measured: 1 week after operation
Electrical stimulation channel number
frequency. The cochlear implant electrode number is recorded.
Measured: 1 month after operation
Electrical stimulation channel number
frequency. The cochlear implant electrode number is recorded.
Measured: 2 months after operation
Electrical stimulation channel number
frequency. The cochlear implant electrode number is recorded.
Measured: 3 months after CI operation
Electrical stimulation channel number
frequency. The cochlear implant electrode number is recorded.
Measured: 4 months after operation
Electrical stimulation channel number
frequency. The cochlear implant electrode number is recorded.
Measured: 7 months after operation
Electrical stimulation channel number
frequency. The cochlear implant electrode number is recorded.
Measured: 13 months after operation
Electrical stimulation channel number
frequency. The cochlear implant electrode number is recorded.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: Pre-operation
Objective electroencephalography-based assessment(EEG)
The EEG waveforms of CI patients were tested, and the amplitude and latency were recorded.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: over 13 months after operation
Speech perception
The patient are tested for speech recognition and the results were recorded as a percentage
Measured: Pre-operation
Speech perception
The patient are tested for speech recognition and the results were recorded as a percentage
Measured: 1 months after operation
Speech perception
The patient are tested for speech recognition and the results were recorded as a percentage
Measured: 2 month after operation
Speech perception
The patient are tested for speech recognition and the results were recorded as a percentage
Measured: 4 months after operation
Speech perception
The patient are tested for speech recognition and the results were recorded as a percentage
Measured: 7 months after operation
Speech perception
The patient are tested for speech recognition and the results were recorded as a percentage
Measured: 13 months after CI operation
Speech perception
The patient are tested for speech recognition and the results were recorded as a percentage
Measured: over 13 months after CI activation
Secondary outcomes (14)
Pure tone test
Evaluation of 250-8000hz hearing effect in patients with hearing loss
Measured: pre-operation
Pure tone test
Evaluation of 250-8000hz hearing effect in patients with hearing loss
Measured: 1 month after operation
Pure tone test
Evaluation of 250-8000hz hearing effect in patients with hearing loss
Measured: 2 months after operation
Pure tone test
Evaluation of 250-8000hz hearing effect in patients with hearing loss
Measured: 4 months after operation
Pure tone test
Evaluation of 250-8000hz hearing effect in patients with hearing loss
Measured: 7 month after operation
Pure tone test
Evaluation of 250-8000hz hearing effect in patients with hearing loss
Measured: 13 month after operation
Pure tone test
Evaluation of 250-8000hz hearing effect in patients with hearing loss
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: over 13 months after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2022
- Study start4 Jul 2022
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TinnitusStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, YangShiming, Chinese PLA General Hospital
- Investigators
- Shi m Yang, M.D., Ph.D., Study director, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05453019
- Sponsor's protocol ID
- CI and Tinnitus 01
- Status last verified
- Jun 2023
- First submitted
- 22 Jun 2022
- Last updated
- 6 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Cochlear Implantation on Tinnitus and Its Symptoms
- ClinicalTrials.gov ID
- NCT05453019
- Acronym / sponsor ID
- CI and Tinnitus 01
- Conditions
- Tinnitus
- Keywords
- tinnitus, electrical stimulation, cochlear implant
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 4 Jul 2022 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 12 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tinnitus group | Experimental | Device: Cochlear ImplantPatients who have tinnitus got cochlear implant |
| without tinnitus group | Active comparator | Device: Cochlear ImplantPatients who have no tinnitus got cochlear implant |
Who may qualify
- Ages
- 16 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cochlear ImplantThe 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. | Device | tinnitus group, without tinnitus group |
Primary outcome
Electrical stimulation channel number
Time frame: 1 week after operation
Stimulating basement membrane with cochlear implant electrode to match tinnitus frequency. The cochlear implant electrode number is recorded.
Electrical stimulation channel number
Time frame: 1 month after operation
frequency. The cochlear implant electrode number is recorded.
Electrical stimulation channel number
Time frame: 2 months after operation
frequency. The cochlear implant electrode number is recorded.
Electrical stimulation channel number
Time frame: 3 months after CI operation
frequency. The cochlear implant electrode number is recorded.
Electrical stimulation channel number
Time frame: 4 months after operation
frequency. The cochlear implant electrode number is recorded.
Electrical stimulation channel number
Time frame: 7 months after operation
frequency. The cochlear implant electrode number is recorded.
Electrical stimulation channel number
Time frame: 13 months after operation
frequency. The cochlear implant electrode number is recorded.
Electrical stimulation channel number
Time frame: over 13 months after operation
frequency. The cochlear implant electrode number is recorded.
Tinnitus characteristic information questionnaire
Time frame: Pre-operation
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.
Tinnitus characteristic information questionnaire
Time frame: 1 week after operation
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.
Tinnitus characteristic information questionnaire
Time frame: 1 month after operation
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.
Tinnitus characteristic information questionnaire
Time frame: 2 months after operation
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.
Tinnitus characteristic information questionnaire
Time frame: 3 months after operation
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.
Tinnitus characteristic information questionnaire
Time frame: 4 months after operation
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.
Tinnitus characteristic information questionnaire
Time frame: 7 months after operation
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.
Tinnitus characteristic information questionnaire
Time frame: 13 months after operation
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.
Tinnitus characteristic information questionnaire
Time frame: over 13 months after operation
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.
Tinnitus loudness(CI electrical stimulation intensity)
Time frame: 1 week after operation
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).
Tinnitus loudness(CI electrical stimulation intensity)
Time frame: 1 month after operation
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).
Tinnitus loudness(CI electrical stimulation intensity)
Time frame: 2 months after operation
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).
Tinnitus loudness(CI electrical stimulation intensity)
Time frame: 3 months after operation
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).
Tinnitus loudness(CI electrical stimulation intensity)
Time frame: 4 months after operation
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).
Tinnitus loudness(CI electrical stimulation intensity)
Time frame: 7 months after operation
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).
Tinnitus loudness(CI electrical stimulation intensity)
Time frame: 13 months after operation
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).
Tinnitus loudness(CI electrical stimulation intensity)
Time frame: over 13 months after operation
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).
Objective electroencephalography-based assessment(EEG)
Time frame: Pre-operation
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.
Objective electroencephalography-based assessment(EEG)
Time frame: 1 week after operation
The EEG waveforms of CI patients were tested, and the amplitude and latency were recorded.
Objective electroencephalography-based assessment(EEG)
Time frame: 1 month after operation
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.
Objective electroencephalography-based assessment(EEG)
Time frame: 2 months after operation
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.
Objective electroencephalography-based assessment(EEG)
Time frame: 3 months after operation
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.
Objective electroencephalography-based assessment(EEG)
Time frame: 4 months after operation
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.
Objective electroencephalography-based assessment(EEG)
Time frame: 7 months after operation
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.
Objective electroencephalography-based assessment(EEG)
Time frame: 13 months after operation
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.
Objective electroencephalography-based assessment(EEG)
Time frame: over 13 months after operation
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.
Speech perception
Time frame: Pre-operation
The patient are tested for speech recognition and the results were recorded as a percentage
Speech perception
Time frame: 1 months after operation
The patient are tested for speech recognition and the results were recorded as a percentage
Speech perception
Time frame: 2 month after operation
The patient are tested for speech recognition and the results were recorded as a percentage
Speech perception
Time frame: 4 months after operation
The patient are tested for speech recognition and the results were recorded as a percentage
Speech perception
Time frame: 7 months after operation
The patient are tested for speech recognition and the results were recorded as a percentage
Speech perception
Time frame: 13 months after CI operation
The patient are tested for speech recognition and the results were recorded as a percentage
Speech perception
Time frame: over 13 months after CI activation
The patient are tested for speech recognition and the results were recorded as a percentage
14 secondary outcomes
Pure tone test
Time frame: pre-operation
Pure tone test
Time frame: 1 month after operation
Pure tone test
Time frame: 2 months after operation
Pure tone test
Time frame: 4 months after operation
Pure tone test
Time frame: 7 month after operation
Pure tone test
Time frame: 13 month after operation
Pure tone test
Time frame: over 13 month after operation
Self-Rating Anxiety Scale (SAS) questionnaire
Time frame: Pre-operation
Self-Rating Anxiety Scale (SAS) questionnaire
Time frame: 1 month after operation
Self-Rating Anxiety Scale (SAS) questionnaire
Time frame: 2 months after operation
Self-Rating Anxiety Scale (SAS) questionnaire
Time frame: 4 months after operation
Self-Rating Anxiety Scale (SAS) questionnaire
Time frame: 7 months after operation
Self-Rating Anxiety Scale (SAS) questionnaire
Time frame: 13 months after operation
Self-Rating Anxiety Scale (SAS) questionnaire
Time frame: over 13 months after operation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shi m Yang, M.D., Ph.D. study director
Chinese PLA General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cochlear Implant in people with Tinnitus, run by Chinese PLA General Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact QIAN WANG, M.S. (+8618211068103, only_elizabeth@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Electrical stimulation channel number (time frame: 1 week after operation). The study lists 41 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2023.