The Study on Effect and Neural Network Mechanism of Transcranial Direct Current Stimulation for Sudden Deafness With Tinnitus
NCT ID: NCT05964725
Last Updated: 2023-11-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
86 participants
INTERVENTIONAL
2023-11-23
2024-08-30
Brief Summary
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Detailed Description
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On-site recruitment will be conducted in the otolaryngology clinic for eligible patients with sudden deafness and tinnitus, with dedicated personnel to recruit subjects, with a total of at least 86 expected recruitment. In order to retain subjects, staff will tell them about the benefits of inclusion in clinical studies for sudden deafness with tinnitus, and actively add subjects' contact information to provide relevant consulting services for subjects during clinical studies. During follow-up, participants will be provided with a free tinnitus-related assessment test to motivate.
Plan for missing data： Screening failure, i.e. subjects did not meet the inclusion and exclusion criteria, or subjects withdrew informed consent, among other things for reasons why it was not included in this clinical study. Study subjects who failed to screen will be pressed according to their own condition Provide appropriate treatment according to clinical guidelines. This subset of subjects will not be included in clinical studies.
Statistical analysis plan:
When considering the influence of baseline, the continuous variables were analyzed by covariance analysis, and the qualitative indicators were tested by CMH test or logistic regression.
Primary analysis： Using covariance analysis to compare the different changes of THI scores between two groups after 5 days treatment, controlled for age and baseline THI.
Secondary analysis： Using covariance analysis to compare the different changes of VAS, BAI, BDI, PSQI scores between two groups after 5 days treatment, controlled for age and baseline values corresponding to each scale.
Using a repeated measure ANOVA to compare the different changes of THI, VAS, BAI, BDI, PSQI between two groups at 1, 3 and 6 follow-up visits.
Using Chi square test or Fisher exact test to compare the different efficient rate between two groups after 5 days treatment.
Exploratory analysis:
Using multiple linear regression analysis to explore the factors affecting the short-term and long -term efficacy of the two treatments, such as age, hearing loss threshold, tinnitus loudness, tinnitus frequency and so on.
Using Independent two sample t-test or nonparametric analysis to compare the differences in EEG- or fMRI-related indicators between two groups.
Safety analysis:
Using Pearson's chi-square test to compare the difference of adverse event incidence rate between two groups.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Receive traditional medical therapy and transcranial direct current stimulation
intravenous methylprednisolone infusion (dose of 1 mg/kg/day, maximum 60 mg/day) for 5 to 10 days. Patients included in this study were routinely examined and tested for audiometry, including otoscopy, pure tone audiometry, acoustic impedance, brainstem evoked potential, and tinnitus detection. After completion, the 32-guide EEG collector from Bricon was used to collect changes in neural activity in all subjects.
Receive traditional medical therapy and transcranial direct current stimulation
Equipment used: Bricon tDCS stimulator, high-precision electrode stimulation method Stimulant dose: 1.5mA Stimulation time: 20 minutes/time, continuous treatment for 5 days Stimulation course: 5 days/course Stimulation target: left auditory cortex area, i.e., under system 10-20, left T3 position.
Receive traditional medical therapy and sham stimulation
Similarly, intravenous methylprednisolone infusion (dose of 1 mg/kg/day, maximum 60 mg/day) for 5 to 10 days. By controlling the tDCS stimulator to mimic only the first 30 seconds of tDCS stimulation, after 30 seconds of pathway resistance control, so that the stimulation intensity is below the threshold, without giving real stimulation, in this process, the position of the stimulation target is not changed, and the rest of the operation is the same.
Receive traditional medical therapy and sham stimulation
By controlling the tDCS stimulator to mimic only the first 30 seconds of tDCS stimulation, after 30 seconds of pathway resistance control, so that the stimulation intensity is below the threshold, without giving real stimulation, in this process, the position of the stimulation target is not changed, and the rest of the operation is the same.
Interventions
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Receive traditional medical therapy and transcranial direct current stimulation
Equipment used: Bricon tDCS stimulator, high-precision electrode stimulation method Stimulant dose: 1.5mA Stimulation time: 20 minutes/time, continuous treatment for 5 days Stimulation course: 5 days/course Stimulation target: left auditory cortex area, i.e., under system 10-20, left T3 position.
Receive traditional medical therapy and sham stimulation
By controlling the tDCS stimulator to mimic only the first 30 seconds of tDCS stimulation, after 30 seconds of pathway resistance control, so that the stimulation intensity is below the threshold, without giving real stimulation, in this process, the position of the stimulation target is not changed, and the rest of the operation is the same.
Eligibility Criteria
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Inclusion Criteria
* Patients with sudden deafness with tinnitus whose course is less than 1 month and have not received any drug treatment
* Age 18-60 years
* Tinnitus frequency is 125-8000 Hz
Exclusion Criteria
* History of head trauma, central nervous system disease, mental disease, and drug abuse
18 Years
60 Years
ALL
No
Sponsors
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Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
OTHER
Responsible Party
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Principal Investigators
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Yuexin Cai, Doctor
Role: PRINCIPAL_INVESTIGATOR
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Locations
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Sun Yat-sen Memorial Hospital
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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References
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Other Identifiers
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SYSKY-2022-499-02
Identifier Type: -
Identifier Source: org_study_id