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The Study on Effect and Neural Network Mechanism of Transcranial Direct Current Stimulation for Sudden Deafness With Tinnitus

Primary Purpose

Tinnitus, Subjective, Sudden Deafness, Transcranial Direct Current Stimulation

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Receive traditional medical therapy and transcranial direct current stimulation
Receive traditional medical therapy and sham stimulation
Sponsored by
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tinnitus, Subjective focused on measuring Acute subjective tinnitus, Clinical trial, Transcranial Direct Current Stimulation

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients with tinnitus as the main complaint: patients subjectively feel sound in the ear or deep part of the head without internal or external sound stimulation, with or without hearing loss, and seek medical treatment 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: Patients with conductive deafness, history of middle ear surgery, pulsatile tinnitus caused by vascular aberration and tinnitus cause by Meniere disease History of head trauma, central nervous system disease, mental disease, and drug abuse

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    Receive traditional medical therapy and transcranial direct current stimulation

    Receive traditional medical therapy and sham stimulation

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Changes in Tinnitus Handicap Inventory (THI) scores for short-term efficacy assessment
    Difference in the change of THI scores between two groups after 5 days treatment. The THI evaluates the severity of tinnitus in terms of emotion and function. The global scores of THI range from 0 (no disability) to 100 (serve disability).

    Secondary Outcome Measures

    Changes in scores of Visual Analog Scale (VAS) for short-term efficacy assessment
    Difference in the change of VAS scores between two groups after 5 days treatment. The total VAS scores range from 0 (negligible) to 10 (too noisy to tolerate), reflecting the loudness of tinnitus patients feel.
    Changes in scores of Beck Anxiety Inventory (BAI) for short-term efficacy assessment
    Difference in the change of BAI scores between two groups after 5 days treatment. The total BAI scores range from 0 (normal) to 63 (serve anxiety), reflecting the degree of anxiety.
    Changes in scores of Beck Depression Inventory (BDI) for short-term efficacy assessment
    Difference in the change of BDI scores between two groups after 5 days treatment. The total BDI scores range from 0 (normal) to 63 (serve depression), reflecting the degree of depression.
    Changes in scores of Pittsburgh sleep quality index (PSQI) for short-term efficacy assessment
    Difference in the change of PSQI scores between two groups after 5 days treatment. The total PSQI scores range from 0 (sleep well) to 21 (quite poor sleep), reflecting the sleep quality.
    Changes of Tinnitus Handicap Inventory (THI) scores in the two groups for long-term efficacy assessment
    Difference in changes of THI between two groups from 1-month follow-up visit to 6-month follow-up visit. The THI evaluates the severity of tinnitus in terms of emotion and function. The global scores of THI range from 0 (no disability) to 100 (serve disability).
    Changes of Visual Analog Scale (VAS) scores in the two groups for long-term efficacy assessment
    Difference in changes of VAS between two groups from 1-month follow-up visit to 6-month follow-up visit. The total VAS scores range from 0 (negligible) to 10 (too noisy to tolerate), reflecting the loudness of tinnitus patients feel.
    Changes of Beck Anxiety Inventory (BAI) scores in the two groups for long-term efficacy assessment
    Difference in changes of BAI between two groups from 1-month follow-up visit to 6-month follow-up visit. The total BAI scores range from 0 (normal) to 63 (serve anxiety), reflecting the degree of anxiety.
    Changes of Beck Depression Inventory (BDI) scores in the two groups for long-term efficacy assessment
    Difference in changes of PSQI between two groups from 1-month follow-up visit to 6-month follow-up visit. The total BDI scores range from 0 (normal) to 63 (serve depression), reflecting the degree of depression.
    Changes of Pittsburgh sleep quality index (PSQI) scores in the two groups for long-term efficacy assessment
    Difference in changes of PSQI between two groups from 1-month follow-up visit to 6-month follow-up visit. The total PSQI scores range from 0 (sleep well) to 21 (quite poor sleep), reflecting the sleep quality.
    The effective rate of relieving sudden deafness with tinnitus in the two groups
    Group effective rate = number of patients in each group who completed 5 days of treatment and whose THI score decreased by ≥ 7 points / number of patients in each group who completed 5 days of treatment.
    The difference of functional connectivity based on resting state electroencephalogram (EEG) between the two groups
    The difference of functional connectivity based on resting state electroencephalogram (EEG) in the two groups from 1-month follow-up visit to 6-month follow-up visit. The functional connectivity is defined as the correlation between two different brain regions based on coherence or phase synchronization.
    The difference of effective connectivity based on resting state electroencephalogram (EEG) between the two groups
    The difference of effective connectivity based on resting state electroencephalogram (EEG) in the two groups from 1-month follow-up visit to 6-month follow-up visit. The effective connectivity is defined as the directed functional connectivity between two brain regions based on granger causality analysis.
    The difference of functional connectivity based on functional magnetic resonance imaging (fMRI) between the two groups
    The difference of functional connectivity based on functional magnetic resonance imaging (fMRI) in the two groups from 1-month follow-up visit to 6-month follow-up visit. The functional connectivity is defined as the Pearson's correlation between two different brain regions.
    The difference of effective connectivity based on functional magnetic resonance imaging (fMRI) between the two groups
    The difference of effective connectivity based on functional magnetic resonance imaging (fMRI) in the two groups from 1-month follow-up visit to 6-month follow-up visit. The effective connectivity is defined as the directed functional connectivity between two brain regions based on granger causality analysis.

    Full Information

    First Posted
    July 16, 2023
    Last Updated
    July 26, 2023
    Sponsor
    Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05964725
    Brief Title
    The Study on Effect and Neural Network Mechanism of Transcranial Direct Current Stimulation for Sudden Deafness With Tinnitus
    Official Title
    The Study on Effect and Neural Network Mechanism of Transcranial Direct Current Stimulation for Sudden Deafness With Tinnitus
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 1, 2023 (Anticipated)
    Primary Completion Date
    August 30, 2024 (Anticipated)
    Study Completion Date
    August 30, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This clinical study is prospective, single-center, randomized, controlled, double-blind clinical trail, which entitled transcranial electrical stimulation for the treatment of acute tinnitus approved by Sun Yat-sen University, and intends to recruit 86 patients with sudden deafness and tinnitus. For acute subjective tinnitus, a common otological disease, the study gave the experimental group patients received tDCS with electrodes positioned over the left temporal cortex for 5 days. To assess the efficacy of conventional medical therapy and tDCS by comparing changes in anterior and posterior tinnitus-related subjective scale scores, such as THI, VAS, BAI, BDI, PSQI, and hearing recovery, in patients who received tDCS, to determine whether tDCS is effective in improving acute tinnitus, and whether it is superior to conventional tinnitus treatment. In addition, the study will continue to follow patients for 1 month,3 months, and 6 months after the end of treatment to observe the long-term sustained efficacy of tDCS. This clinical trail will also evaluate tDCS from the perspective of compliance and safety, and explore the factors affecting the efficacy of this therapy.
    Detailed Description
    Sample size estimation: 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Tinnitus, Subjective, Sudden Deafness, Transcranial Direct Current Stimulation, Double-Blind Method, Female, Male, Human, Treatment Outcome
    Keywords
    Acute subjective tinnitus, Clinical trial, Transcranial Direct Current Stimulation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Participants in the included studies were randomized 1:1 by statisticians. The statistician will number the subjects using a computer-generated random number table, then arrange them in order of number size, and then randomly divide the subjects into random blocks of length 2 or 4 to complete the randomization.
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Masking Description
    In the whole clinical research process, the subjects and researchers participating in the efficacy and safety evaluation should be in a blind state, that is, neither of them knows the specific intervention measures given to the subjects. For participant, the treatment equipment is exactly the same between the two groups. Also, 10 seconds sham stimulation at the beginning of treatment is set in the control group for minimizing risk of participants being able to guess treatment allocation. The randomized allocation is completed by a unified randomization center. Therefore, the investigators in each center just know "A" or "B" for the allocation information of each participant. For outcomes assessors, they are only responsible for baseline and follow-up assessment during the study.
    Allocation
    Randomized
    Enrollment
    86 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Receive traditional medical therapy and transcranial direct current stimulation
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Receive traditional medical therapy and sham stimulation
    Arm Type
    Sham Comparator
    Arm Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    Receive traditional medical therapy and transcranial direct current stimulation
    Intervention Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    Receive traditional medical therapy and sham stimulation
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Changes in Tinnitus Handicap Inventory (THI) scores for short-term efficacy assessment
    Description
    Difference in the change of THI scores between two groups after 5 days treatment. The THI evaluates the severity of tinnitus in terms of emotion and function. The global scores of THI range from 0 (no disability) to 100 (serve disability).
    Time Frame
    From baseline to after 5 days treatment
    Secondary Outcome Measure Information:
    Title
    Changes in scores of Visual Analog Scale (VAS) for short-term efficacy assessment
    Description
    Difference in the change of VAS scores between two groups after 5 days treatment. The total VAS scores range from 0 (negligible) to 10 (too noisy to tolerate), reflecting the loudness of tinnitus patients feel.
    Time Frame
    From baseline to after 5 days treatment
    Title
    Changes in scores of Beck Anxiety Inventory (BAI) for short-term efficacy assessment
    Description
    Difference in the change of BAI scores between two groups after 5 days treatment. The total BAI scores range from 0 (normal) to 63 (serve anxiety), reflecting the degree of anxiety.
    Time Frame
    From baseline to after 5 days treatment
    Title
    Changes in scores of Beck Depression Inventory (BDI) for short-term efficacy assessment
    Description
    Difference in the change of BDI scores between two groups after 5 days treatment. The total BDI scores range from 0 (normal) to 63 (serve depression), reflecting the degree of depression.
    Time Frame
    From baseline to after 5 days treatment
    Title
    Changes in scores of Pittsburgh sleep quality index (PSQI) for short-term efficacy assessment
    Description
    Difference in the change of PSQI scores between two groups after 5 days treatment. The total PSQI scores range from 0 (sleep well) to 21 (quite poor sleep), reflecting the sleep quality.
    Time Frame
    From baseline to after 5 days treatment
    Title
    Changes of Tinnitus Handicap Inventory (THI) scores in the two groups for long-term efficacy assessment
    Description
    Difference in changes of THI between two groups from 1-month follow-up visit to 6-month follow-up visit. The THI evaluates the severity of tinnitus in terms of emotion and function. The global scores of THI range from 0 (no disability) to 100 (serve disability).
    Time Frame
    From 1-month follow-up visit to 6-month follow-up visit
    Title
    Changes of Visual Analog Scale (VAS) scores in the two groups for long-term efficacy assessment
    Description
    Difference in changes of VAS between two groups from 1-month follow-up visit to 6-month follow-up visit. The total VAS scores range from 0 (negligible) to 10 (too noisy to tolerate), reflecting the loudness of tinnitus patients feel.
    Time Frame
    From 1-month follow-up visit to 6-month follow-up visit
    Title
    Changes of Beck Anxiety Inventory (BAI) scores in the two groups for long-term efficacy assessment
    Description
    Difference in changes of BAI between two groups from 1-month follow-up visit to 6-month follow-up visit. The total BAI scores range from 0 (normal) to 63 (serve anxiety), reflecting the degree of anxiety.
    Time Frame
    From 1-month follow-up visit to 6-month follow-up visit
    Title
    Changes of Beck Depression Inventory (BDI) scores in the two groups for long-term efficacy assessment
    Description
    Difference in changes of PSQI between two groups from 1-month follow-up visit to 6-month follow-up visit. The total BDI scores range from 0 (normal) to 63 (serve depression), reflecting the degree of depression.
    Time Frame
    From 1-month follow-up visit to 6-month follow-up visit
    Title
    Changes of Pittsburgh sleep quality index (PSQI) scores in the two groups for long-term efficacy assessment
    Description
    Difference in changes of PSQI between two groups from 1-month follow-up visit to 6-month follow-up visit. The total PSQI scores range from 0 (sleep well) to 21 (quite poor sleep), reflecting the sleep quality.
    Time Frame
    From 1-month follow-up visit to 6-month follow-up visit
    Title
    The effective rate of relieving sudden deafness with tinnitus in the two groups
    Description
    Group effective rate = number of patients in each group who completed 5 days of treatment and whose THI score decreased by ≥ 7 points / number of patients in each group who completed 5 days of treatment.
    Time Frame
    From baseline to after 5 days treatment
    Title
    The difference of functional connectivity based on resting state electroencephalogram (EEG) between the two groups
    Description
    The difference of functional connectivity based on resting state electroencephalogram (EEG) in the two groups from 1-month follow-up visit to 6-month follow-up visit. The functional connectivity is defined as the correlation between two different brain regions based on coherence or phase synchronization.
    Time Frame
    From 1-month follow-up visit to 6-month follow-up visit
    Title
    The difference of effective connectivity based on resting state electroencephalogram (EEG) between the two groups
    Description
    The difference of effective connectivity based on resting state electroencephalogram (EEG) in the two groups from 1-month follow-up visit to 6-month follow-up visit. The effective connectivity is defined as the directed functional connectivity between two brain regions based on granger causality analysis.
    Time Frame
    From 1-month follow-up visit to 6-month follow-up visit
    Title
    The difference of functional connectivity based on functional magnetic resonance imaging (fMRI) between the two groups
    Description
    The difference of functional connectivity based on functional magnetic resonance imaging (fMRI) in the two groups from 1-month follow-up visit to 6-month follow-up visit. The functional connectivity is defined as the Pearson's correlation between two different brain regions.
    Time Frame
    From 1-month follow-up visit to 6-month follow-up visit
    Title
    The difference of effective connectivity based on functional magnetic resonance imaging (fMRI) between the two groups
    Description
    The difference of effective connectivity based on functional magnetic resonance imaging (fMRI) in the two groups from 1-month follow-up visit to 6-month follow-up visit. The effective connectivity is defined as the directed functional connectivity between two brain regions based on granger causality analysis.
    Time Frame
    From 1-month follow-up visit to 6-month follow-up visit
    Other Pre-specified Outcome Measures:
    Title
    Incidence of treatment-related adverse events
    Description
    Treatment related adverse events in two groups include: auditory system related adverse reactions caused by treatment, such as auricle burn, earache, hearing loss, tinnitus aggravation, and head injury Dizziness, headache, palpitation, vomiting and other non auditory system related adverse reactions. Incidence of adverse events = number of treatment-related adverse events during treatment / total number of participants in treatment.
    Time Frame
    From baseline to 6-month follow-up visit

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients with tinnitus as the main complaint: patients subjectively feel sound in the ear or deep part of the head without internal or external sound stimulation, with or without hearing loss, and seek medical treatment 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: Patients with conductive deafness, history of middle ear surgery, pulsatile tinnitus caused by vascular aberration and tinnitus cause by Meniere disease History of head trauma, central nervous system disease, mental disease, and drug abuse
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yuexin Cai, Doctor
    Phone
    +8613825063663
    Email
    panada810456@126.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Yuexin Cai, Doctor
    Organizational Affiliation
    Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    The Study on Effect and Neural Network Mechanism of Transcranial Direct Current Stimulation for Sudden Deafness With Tinnitus

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