Effects of CI on Tinnitus and Its Symptoms

Condition(s) studied

Investigational drug(s) / intervention(s)

Cochlear Implant: 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 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.

Eligibility

Primary outcome measure(s)

• Electrical stimulation channel number — 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 — 1 month after operation
  frequency. The cochlear implant electrode number is recorded.
• Electrical stimulation channel number — 2 months after operation
  frequency. The cochlear implant electrode number is recorded.
• Electrical stimulation channel number — 3 months after CI operation
  frequency. The cochlear implant electrode number is recorded.
• Electrical stimulation channel number — 4 months after operation
  frequency. The cochlear implant electrode number is recorded.
• Electrical stimulation channel number — 7 months after operation
  frequency. The cochlear implant electrode number is recorded.
• Electrical stimulation channel number — 13 months after operation
  frequency. The cochlear implant electrode number is recorded.
• Electrical stimulation channel number — over 13 months after operation
  frequency. The cochlear implant electrode number is recorded.
• Tinnitus characteristic information questionnaire — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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) — 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) — 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) — 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) — 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) — 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) — 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) — 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) — 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) — 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) — 1 week after operation
  The EEG waveforms of CI patients were tested, and the amplitude and latency were recorded.
• Objective electroencephalography-based assessment(EEG) — 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) — 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) — 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) — 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) — 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) — 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) — 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 — Pre-operation
  The patient are tested for speech recognition and the results were recorded as a percentage
• Speech perception — 1 months after operation
  The patient are tested for speech recognition and the results were recorded as a percentage
• Speech perception — 2 month after operation
  The patient are tested for speech recognition and the results were recorded as a percentage
• Speech perception — 4 months after operation
  The patient are tested for speech recognition and the results were recorded as a percentage
• Speech perception — 7 months after operation
  The patient are tested for speech recognition and the results were recorded as a percentage
• Speech perception — 13 months after CI operation
  The patient are tested for speech recognition and the results were recorded as a percentage
• Speech perception — over 13 months after CI activation
  The patient are tested for speech recognition and the results were recorded as a percentage

Trial sites (1)

Other trials for the same condition