Effects of CI on Tinnitus and Its Symptoms
Effects of Cochlear Implantation on Tinnitus and Its Symptoms
1 other identifier
interventional
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 22, 2022
CompletedStudy Start
First participant enrolled
July 4, 2022
CompletedFirst Posted
Study publicly available on registry
July 12, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2027
June 6, 2023
June 1, 2023
5 years
June 22, 2022
June 5, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (41)
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 Outcomes (14)
Pure tone test
pre-operation
Pure tone test
1 month after operation
Pure tone test
2 months after operation
Pure tone test
4 months after operation
Pure tone test
7 month after operation
- +9 more secondary outcomes
Study Arms (2)
tinnitus group
EXPERIMENTALPatients who have tinnitus got cochlear implant
without tinnitus group
ACTIVE COMPARATORPatients who have no tinnitus got cochlear implant
Interventions
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.
Eligibility Criteria
You may qualify if:
- \. 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Qian Wang
Beijing, France, 100085, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Shi m Yang, M.D., Ph.D.
Chinese PLA General Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
June 22, 2022
First Posted
July 12, 2022
Study Start
July 4, 2022
Primary Completion (Estimated)
July 1, 2027
Study Completion (Estimated)
July 1, 2027
Last Updated
June 6, 2023
Record last verified: 2023-06