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

Transcranial Direct Current Stimulation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05964725
• Other study ID #: SYSKY-2022-499-02
• Status: Recruiting
• Phase: N/A
• Start date: November 23, 2023
• Est. completion date: August 30, 2024

Study information

• Verified date: November 2023
• Source: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Contact: Yuexin Cai, Doctor
• Phone: +8613825063663
• Email: panada810456[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 86
• Est. completion date: August 30, 2024
• Est. primary completion date: August 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Deafness
• Female
• Hearing Loss
• Hearing Loss, Sudden
• Human
• Male
• Sudden Deafness
• Tinnitus
• Tinnitus, Subjective
• Transcranial Direct Current Stimulation
• Treatment Outcome

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Sun Yat-sen Memorial Hospital	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Country where clinical trial is conducted

China, 

References & Publications (19)

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Faber 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. — View Citation

Frank 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. — View Citation

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Pal 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. — View Citation

Rah 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. — View Citation

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Vanneste 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. — View Citation

Vanneste 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. — View Citation

Vanneste S, Langguth B, De Ridder D. Do tDCS and TMS influence tinnitus transiently via a direct cortical and indirect somatosensory modulating effect? A combined TMS-tDCS and TENS study. Brain Stimul. 2011 Oct;4(4):242-52. doi: 10.1016/j.brs.2010.12.001. Epub 2011 Jan 1. — View Citation

Vanneste 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. — View Citation

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Yakunina N, Nam EC. Direct and Transcutaneous Vagus Nerve Stimulation for Treatment of Tinnitus: A Scoping Review. Front Neurosci. 2021 May 28;15:680590. doi: 10.3389/fnins.2021.680590. eCollection 2021. — View Citation

Zhou 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. — View Citation

* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of treatment-related adverse events	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.	From baseline to 6-month follow-up visit
Primary	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).	From baseline to after 5 days treatment
Secondary	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.	From baseline to after 5 days treatment
Secondary	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.	From baseline to after 5 days treatment
Secondary	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.	From baseline to after 5 days treatment
Secondary	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.	From baseline to after 5 days treatment
Secondary	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).	From 1-month follow-up visit to 6-month follow-up visit
Secondary	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.	From 1-month follow-up visit to 6-month follow-up visit
Secondary	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.	From 1-month follow-up visit to 6-month follow-up visit
Secondary	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.	From 1-month follow-up visit to 6-month follow-up visit
Secondary	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.	From 1-month follow-up visit to 6-month follow-up visit
Secondary	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.	From baseline to after 5 days treatment
Secondary	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.	From 1-month follow-up visit to 6-month follow-up visit
Secondary	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.	From 1-month follow-up visit to 6-month follow-up visit
Secondary	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.	From 1-month follow-up visit to 6-month follow-up visit
Secondary	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.	From 1-month follow-up visit to 6-month follow-up visit