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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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ClinicalTrials.gov Identifier: NCT05964725
Recruitment Status : Recruiting
First Posted : July 28, 2023
Last Update Posted : November 27, 2023
Sponsor:
Information provided by (Responsible Party):
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Tinnitus, Subjective Sudden Deafness Transcranial Direct Current Stimulation Double-Blind Method Female Male Human Treatment Outcome Device: Receive traditional medical therapy and transcranial direct current stimulation Device: Receive traditional medical therapy and sham stimulation Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: Quadruple (Participant, Care Provider, Investigator, Outcomes 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.
Primary Purpose: Treatment
Official Title: The Study on Effect and Neural Network Mechanism of Transcranial Direct Current Stimulation for Sudden Deafness With Tinnitus
Estimated Study Start Date : November 23, 2023
Estimated Primary Completion Date : August 30, 2024
Estimated Study Completion Date : August 30, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Device: 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.
Sham Comparator: 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.
 Device: 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.


Outcome Measures
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Primary Outcome Measures :
  1. Changes in Tinnitus Handicap Inventory (THI) scores for short-term efficacy assessment [ Time Frame: From baseline to after 5 days treatment ]
    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 :
  1. Changes in scores of Visual Analog Scale (VAS) for short-term efficacy assessment [ Time Frame: From baseline to after 5 days treatment ]
    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.

  2. Changes in scores of Beck Anxiety Inventory (BAI) for short-term efficacy assessment [ Time Frame: From baseline to after 5 days treatment ]
    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.

  3. Changes in scores of Beck Depression Inventory (BDI) for short-term efficacy assessment [ Time Frame: From baseline to after 5 days treatment ]
    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.

  4. Changes in scores of Pittsburgh sleep quality index (PSQI) for short-term efficacy assessment [ Time Frame: From baseline to after 5 days treatment ]
    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.

  5. Changes of Tinnitus Handicap Inventory (THI) scores in the two groups for long-term efficacy assessment [ Time Frame: From 1-month follow-up visit to 6-month follow-up visit ]
    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).

  6. Changes of Visual Analog Scale (VAS) scores in the two groups for long-term efficacy assessment [ Time Frame: From 1-month follow-up visit to 6-month follow-up visit ]
    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.

  7. Changes of Beck Anxiety Inventory (BAI) scores in the two groups for long-term efficacy assessment [ Time Frame: From 1-month follow-up visit to 6-month follow-up visit ]
    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.

  8. Changes of Beck Depression Inventory (BDI) scores in the two groups for long-term efficacy assessment [ Time Frame: From 1-month follow-up visit to 6-month follow-up visit ]
    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.

  9. Changes of Pittsburgh sleep quality index (PSQI) scores in the two groups for long-term efficacy assessment [ Time Frame: From 1-month follow-up visit to 6-month follow-up visit ]
    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.

  10. The effective rate of relieving sudden deafness with tinnitus in the two groups [ Time Frame: From baseline to after 5 days treatment ]
    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.

  11. The difference of functional connectivity based on resting state electroencephalogram (EEG) between the two groups [ Time Frame: From 1-month follow-up visit to 6-month follow-up visit ]
    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.

  12. The difference of effective connectivity based on resting state electroencephalogram (EEG) between the two groups [ Time Frame: From 1-month follow-up visit to 6-month follow-up visit ]
    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.

  13. The difference of functional connectivity based on functional magnetic resonance imaging (fMRI) between the two groups [ Time Frame: From 1-month follow-up visit to 6-month follow-up visit ]
    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.

  14. The difference of effective connectivity based on functional magnetic resonance imaging (fMRI) between the two groups [ Time Frame: From 1-month follow-up visit to 6-month follow-up visit ]
    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.


Other Outcome Measures:
  1. Incidence of treatment-related adverse events [ Time Frame: From baseline to 6-month follow-up visit ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05964725


Contacts
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Contact: Yuexin Cai, Doctor +8613825063663 panada810456@126.com

Locations
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China, Guangdong
Sun Yat-sen Memorial Hospital Recruiting
Guangzhou, Guangdong, China, 510120
Contact: Yuexin Cai    +8613825063663    caiyx25@mail.sysu.edu.cn   
Sponsors and Collaborators
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Investigators
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Principal Investigator: Yuexin Cai, Doctor Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
More Information
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Publications:

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Responsible Party: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT05964725    
Other Study ID Numbers: SYSKY-2022-499-02
First Posted: July 28, 2023    Key Record Dates
Last Update Posted: November 27, 2023
Last Verified: November 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University:
Acute subjective tinnitus
Clinical trial
Transcranial Direct Current Stimulation
Additional relevant MeSH terms:
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Tinnitus
Deafness
Hearing Loss
Hearing Loss, Sudden
Hearing Disorders
 Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases