Tinnitus, SubjectiveNCT05964725
The Study on Effect and Neural Network Mechanism of Transcranial Direct Current Stimulation for Sudden Deafness With Tinnitus
A study testing Receive traditional medical therapy and transcranial direct current stimulation in people with Tinnitus, Subjective and Sudden Deafness, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Tinnitus, Subjective, Sudden Deafness, Transcranial Direct Current Stimulation
- What is being tested?
- Receive traditional medical therapy and transcranial direct current stimulation
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 86 participants
- Where
- 1 siteChina
- Study dates
- 23 Nov 2023to 30 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen Memorial Hospital
Guangzhou, Guangdong, 510120
Yuexin Cai, +8613825063663, caiyx25@mail.sysu.edu.cn
About this study
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.
Read the 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.
- Conditions
- Tinnitus, Subjective, Sudden Deafness, Transcranial Direct Current Stimulation, Double-Blind Method, Female, Male
- Being tested
- Receive traditional medical therapy and transcranial direct current stimulation, Receive traditional medical therapy and sham stimulation
- Keywords
- Acute subjective tinnitus, Clinical trial, Transcranial Direct Current Stimulation
- Medical subject headings
- Tinnitus, Hearing Loss, Sudden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Receive traditional medical therapy and transcranial direct current stimulationDevice
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 stimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Receive traditional medical therapy and transcranial direct current stimulation | Experimental | 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. Receives: Device: Receive traditional medical therapy and transcranial direct current stimulation |
| Receive traditional medical therapy and sham stimulation | Sham comparator | 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. Receives: Device: Receive traditional medical therapy and sham stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From baseline to after 5 days treatment
Secondary outcomes (14)
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.
Measured: From baseline to after 5 days treatment
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.
Measured: From baseline to after 5 days treatment
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.
Measured: From baseline to after 5 days treatment
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.
Measured: From baseline to after 5 days treatment
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).
Measured: From 1-month follow-up visit to 6-month follow-up visit
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.
Measured: From 1-month follow-up visit to 6-month follow-up visit
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.
Measured: From 1-month follow-up visit to 6-month follow-up visit
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.
Measured: From 1-month follow-up visit to 6-month follow-up visit
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.
Measured: From 1-month follow-up visit to 6-month follow-up visit
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.
Measured: From baseline to after 5 days 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.
Measured: From 1-month follow-up visit to 6-month follow-up visit
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.
Measured: From 1-month follow-up visit to 6-month follow-up visit
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.
Measured: From 1-month follow-up visit to 6-month follow-up visit
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.
Measured: From 1-month follow-up visit to 6-month follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2023
- Study start23 Nov 2023 (estimated)
- Primary completion30 Aug 2024 (estimated)
- Study completion30 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Tinnitus, SubjectiveStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yuexin Cai, Doctor, Principal investigator, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05964725
- Sponsor's protocol ID
- SYSKY-2022-499-02
- Status last verified
- Nov 2023
- First submitted
- 16 Jul 2023
- Last updated
- 27 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chandrasekhar SS, Tsai Do BS, Schwartz SR, Bontempo LJ, Faucett EA, Finestone SA, Hollingsworth DB, Kelley DM, Kmucha ST, Moonis G, Poling GL, Roberts JK, Stachler RJ, Zeitler DM, Corrigan MD, Nnacheta LC, Satterfield L. Clinical Practice Guideline: Sudden Hearing Loss (Update). Otolaryngol Head Neck Surg. 2019 Aug;161(1_suppl):S1-S45. doi: 10.1177/0194599819859885.
PubMed 31369359Rah YC, Park KT, Yi YJ, Seok J, Kang SI, Kim YH. Successful treatment of sudden sensorineural hearing loss assures improvement of accompanying tinnitus. Laryngoscope. 2015 Jun;125(6):1433-7. doi: 10.1002/lary.25074. Epub 2014 Dec 4.
PubMed 25476777Klemm E, Bepperling F, Burschka MA, Mosges R; Study Group. Hemodilution therapy with hydroxyethyl starch solution (130/0.4) in unilateral idiopathic sudden sensorineural hearing loss: a dose-finding, double-blind, placebo-controlled, international multicenter trial with 210 patients. Otol Neurotol. 2007 Feb;28(2):157-70. doi: 10.1097/01.mao.0000231502.54157.ad.
PubMed 17255882Westerlaken BO, de Kleine E, van der Laan B, Albers F. The treatment of idiopathic sudden sensorineural hearing loss using pulse therapy: a prospective, randomized, double-blind clinical trial. Laryngoscope. 2007 Apr;117(4):684-90. doi: 10.1097/mlg.0b013e3180316d3b.
PubMed 17415139Zhou GP, Chen YC, Li WW, Wei HL, Yu YS, Zhou QQ, Yin X, Tao YJ, Zhang H. Aberrant functional and effective connectivity of the frontostriatal network in unilateral acute tinnitus patients with hearing loss. Brain Imaging Behav. 2022 Feb;16(1):151-160. doi: 10.1007/s11682-021-00486-9. Epub 2021 Jul 23.
PubMed 34296381Aldhafeeri FM, Mackenzie I, Kay T, Alghamdi J, Sluming V. Neuroanatomical correlates of tinnitus revealed by cortical thickness analysis and diffusion tensor imaging. Neuroradiology. 2012 Aug;54(8):883-92. doi: 10.1007/s00234-012-1044-6. Epub 2012 May 22.
PubMed 22614806Cai Y, Xie M, Su Y, Tong Z, Wu X, Xu W, Li J, Zhao F, Dang C, Chen G, Lan L, Shen J, Zheng Y. Aberrant Functional and Causal Connectivity in Acute Tinnitus With Sensorineural Hearing Loss. Front Neurosci. 2020 Jun 30;14:592. doi: 10.3389/fnins.2020.00592. eCollection 2020.
PubMed 32714128Lefaucheur JP, Antal A, Ayache SS, Benninger DH, Brunelin J, Cogiamanian F, Cotelli M, De Ridder D, Ferrucci R, Langguth B, Marangolo P, Mylius V, Nitsche MA, Padberg F, Palm U, Poulet E, Priori A, Rossi S, Schecklmann M, Vanneste S, Ziemann U, Garcia-Larrea L, Paulus W. Evidence-based guidelines on the therapeutic use of transcranial direct current stimulation (tDCS). Clin Neurophysiol. 2017 Jan;128(1):56-92. doi: 10.1016/j.clinph.2016.10.087. Epub 2016 Oct 29.
PubMed 27866120Teismann H, Wollbrink A, Okamoto H, Schlaug G, Rudack C, Pantev C. Combining transcranial direct current stimulation and tailor-made notched music training to decrease tinnitus-related distress--a pilot study. PLoS One. 2014 Feb 25;9(2):e89904. doi: 10.1371/journal.pone.0089904. eCollection 2014.
PubMed 24587113Pal N, Maire R, Stephan MA, Herrmann FR, Benninger DH. Transcranial Direct Current Stimulation for the Treatment of Chronic Tinnitus: A Randomized Controlled Study. Brain Stimul. 2015 Nov-Dec;8(6):1101-7. doi: 10.1016/j.brs.2015.06.014. Epub 2015 Jun 27.
PubMed 26198363Vanneste S, De Ridder D. Bifrontal transcranial direct current stimulation modulates tinnitus intensity and tinnitus-distress-related brain activity. Eur J Neurosci. 2011 Aug;34(4):605-14. doi: 10.1111/j.1460-9568.2011.07778.x. Epub 2011 Jul 25.
PubMed 21790807Vanneste S, Plazier M, Ost J, van der Loo E, Van de Heyning P, De Ridder D. Bilateral dorsolateral prefrontal cortex modulation for tinnitus by transcranial direct current stimulation: a preliminary clinical study. Exp Brain Res. 2010 May;202(4):779-85. doi: 10.1007/s00221-010-2183-9. Epub 2010 Feb 26.
PubMed 20186404Vanneste S, Focquaert F, Van de Heyning P, De Ridder D. Different resting state brain activity and functional connectivity in patients who respond and not respond to bifrontal tDCS for tinnitus suppression. Exp Brain Res. 2011 Apr;210(2):217-27. doi: 10.1007/s00221-011-2617-z. Epub 2011 Mar 25.
PubMed 21437634Faber M, Vanneste S, Fregni F, De Ridder D. Top down prefrontal affective modulation of tinnitus with multiple sessions of tDCS of dorsolateral prefrontal cortex. Brain Stimul. 2012 Oct;5(4):492-8. doi: 10.1016/j.brs.2011.09.003. Epub 2011 Oct 5.
PubMed 22019079Frank E, Schecklmann M, Landgrebe M, Burger J, Kreuzer P, Poeppl TB, Kleinjung T, Hajak G, Langguth B. Treatment of chronic tinnitus with repeated sessions of prefrontal transcranial direct current stimulation: outcomes from an open-label pilot study. J Neurol. 2012 Feb;259(2):327-33. doi: 10.1007/s00415-011-6189-4. Epub 2011 Aug 2.
PubMed 21808984
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study on Effect and Neural Network Mechanism of Transcranial Direct Current Stimulation for Sudden Deafness With Tinnitus
- ClinicalTrials.gov ID
- NCT05964725
- Acronym / sponsor ID
- SYSKY-2022-499-02
- Conditions
- Tinnitus, Subjective, Sudden Deafness, Transcranial Direct Current Stimulation, Double-Blind Method, Female, Male
- Keywords
- Acute subjective tinnitus, Clinical trial, Transcranial Direct Current Stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 23 Nov 2023 (estimated)
- Primary completion
- 30 Aug 2024 (estimated)
- Study completion
- 30 Aug 2024 (estimated)
- First posted
- 28 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Receive traditional medical therapy and transcranial direct current stimulation | Experimental | Device: Receive traditional medical therapy and transcranial direct current stimulationintravenous 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 sham stimulation | Sham comparator | Device: Receive traditional medical therapy and sham stimulationSimilarly, 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Receive traditional medical therapy and transcranial direct current stimulationEquipment 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. | Device | Receive traditional medical therapy and transcranial direct current stimulation |
| Receive traditional medical therapy and sham stimulationBy 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 |
Primary outcome
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).
14 secondary outcomes
Changes in scores of Visual Analog Scale (VAS) for short-term efficacy assessment
Time frame: From baseline to after 5 days treatment
Changes in scores of Beck Anxiety Inventory (BAI) for short-term efficacy assessment
Time frame: From baseline to after 5 days treatment
Changes in scores of Beck Depression Inventory (BDI) for short-term efficacy assessment
Time frame: From baseline to after 5 days treatment
Changes in scores of Pittsburgh sleep quality index (PSQI) for short-term efficacy assessment
Time frame: From baseline to after 5 days treatment
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
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
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
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
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
The effective rate of relieving sudden deafness with tinnitus in the two groups
Time frame: From baseline to after 5 days treatment
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 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 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 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2023.
- Background: PubMed 31369359Chandrasekhar SS, Tsai Do BS, Schwartz SR, Bontempo LJ, Faucett EA, Finestone SA, Hollingsworth DB, Kelley DM, Kmucha ST, Moonis G, Poling GL, Roberts JK, Stachler RJ, Zeitler DM, Corrigan MD, Nnacheta LC, Satterfield L. Clinical Practice Guideline: Sudden Hearing Loss (Update). Otolaryngol Head Neck Surg. 2019 Aug;161(1_suppl):S1-S45. doi: 10.1177/0194599819859885.
- Background: PubMed 25476777Rah YC, Park KT, Yi YJ, Seok J, Kang SI, Kim YH. Successful treatment of sudden sensorineural hearing loss assures improvement of accompanying tinnitus. Laryngoscope. 2015 Jun;125(6):1433-7. doi: 10.1002/lary.25074. Epub 2014 Dec 4.
- Background: PubMed 17255882Klemm E, Bepperling F, Burschka MA, Mosges R; Study Group. Hemodilution therapy with hydroxyethyl starch solution (130/0.4) in unilateral idiopathic sudden sensorineural hearing loss: a dose-finding, double-blind, placebo-controlled, international multicenter trial with 210 patients. Otol Neurotol. 2007 Feb;28(2):157-70. doi: 10.1097/01.mao.0000231502.54157.ad.
- Background: PubMed 17415139Westerlaken BO, de Kleine E, van der Laan B, Albers F. The treatment of idiopathic sudden sensorineural hearing loss using pulse therapy: a prospective, randomized, double-blind clinical trial. Laryngoscope. 2007 Apr;117(4):684-90. doi: 10.1097/mlg.0b013e3180316d3b.
- Background: PubMed 34296381Zhou GP, Chen YC, Li WW, Wei HL, Yu YS, Zhou QQ, Yin X, Tao YJ, Zhang H. Aberrant functional and effective connectivity of the frontostriatal network in unilateral acute tinnitus patients with hearing loss. Brain Imaging Behav. 2022 Feb;16(1):151-160. doi: 10.1007/s11682-021-00486-9. Epub 2021 Jul 23.
- Background: PubMed 22614806Aldhafeeri FM, Mackenzie I, Kay T, Alghamdi J, Sluming V. Neuroanatomical correlates of tinnitus revealed by cortical thickness analysis and diffusion tensor imaging. Neuroradiology. 2012 Aug;54(8):883-92. doi: 10.1007/s00234-012-1044-6. Epub 2012 May 22.
- Background: PubMed 32714128Cai Y, Xie M, Su Y, Tong Z, Wu X, Xu W, Li J, Zhao F, Dang C, Chen G, Lan L, Shen J, Zheng Y. Aberrant Functional and Causal Connectivity in Acute Tinnitus With Sensorineural Hearing Loss. Front Neurosci. 2020 Jun 30;14:592. doi: 10.3389/fnins.2020.00592. eCollection 2020.
- Background: PubMed 27866120Lefaucheur JP, Antal A, Ayache SS, Benninger DH, Brunelin J, Cogiamanian F, Cotelli M, De Ridder D, Ferrucci R, Langguth B, Marangolo P, Mylius V, Nitsche MA, Padberg F, Palm U, Poulet E, Priori A, Rossi S, Schecklmann M, Vanneste S, Ziemann U, Garcia-Larrea L, Paulus W. Evidence-based guidelines on the therapeutic use of transcranial direct current stimulation (tDCS). Clin Neurophysiol. 2017 Jan;128(1):56-92. doi: 10.1016/j.clinph.2016.10.087. Epub 2016 Oct 29.
- Background: PubMed 24587113Teismann H, Wollbrink A, Okamoto H, Schlaug G, Rudack C, Pantev C. Combining transcranial direct current stimulation and tailor-made notched music training to decrease tinnitus-related distress--a pilot study. PLoS One. 2014 Feb 25;9(2):e89904. doi: 10.1371/journal.pone.0089904. eCollection 2014.
- Background: PubMed 26198363Pal N, Maire R, Stephan MA, Herrmann FR, Benninger DH. Transcranial Direct Current Stimulation for the Treatment of Chronic Tinnitus: A Randomized Controlled Study. Brain Stimul. 2015 Nov-Dec;8(6):1101-7. doi: 10.1016/j.brs.2015.06.014. Epub 2015 Jun 27.
- Background: PubMed 21790807Vanneste S, De Ridder D. Bifrontal transcranial direct current stimulation modulates tinnitus intensity and tinnitus-distress-related brain activity. Eur J Neurosci. 2011 Aug;34(4):605-14. doi: 10.1111/j.1460-9568.2011.07778.x. Epub 2011 Jul 25.
- Background: PubMed 20186404Vanneste S, Plazier M, Ost J, van der Loo E, Van de Heyning P, De Ridder D. Bilateral dorsolateral prefrontal cortex modulation for tinnitus by transcranial direct current stimulation: a preliminary clinical study. Exp Brain Res. 2010 May;202(4):779-85. doi: 10.1007/s00221-010-2183-9. Epub 2010 Feb 26.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yuexin Cai, Doctor principal investigator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Receive traditional medical therapy and transcranial direct current stimulation in people with Tinnitus, Subjective and Sudden Deafness, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yuexin Cai, Doctor (+8613825063663, panada810456@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Tinnitus Handicap Inventory (THI) scores for short-term efficacy assessment (time frame: From baseline to after 5 days treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05964725, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2023.