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

NCT05964725 | Unknown

• 1 other identifier: SYSKY-2022-499-02
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• Changes in scores of Visual Analog Scale (VAS) for short-term efficacy assessment

  From baseline to after 5 days treatment

• Changes in scores of Beck Anxiety Inventory (BAI) for short-term efficacy assessment

  From baseline to after 5 days treatment

• Changes in scores of Beck Depression Inventory (BDI) for short-term efficacy assessment

  From baseline to after 5 days treatment

• Changes in scores of Pittsburgh sleep quality index (PSQI) for short-term efficacy assessment

  From baseline to after 5 days treatment

• Changes of Tinnitus Handicap Inventory (THI) scores in the two groups for long-term efficacy assessment

  From 1-month follow-up visit to 6-month follow-up visit

Other Outcomes (1)

• Incidence of treatment-related adverse events

  From baseline to 6-month follow-up visit

Study Arms (2)

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.

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.

Device: Receive traditional medical therapy and sham stimulation

Interventions

Receive traditional medical therapy and transcranial direct current stimulation DEVICE

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 transcranial direct current stimulation

Receive traditional medical therapy and sham stimulation DEVICE

By controlling the tDCS stimulator to mimic only the first 30 seconds of tDCS stimulation, after 30 seconds of pathway resistance control, so that the stimulation intensity is below the threshold, without giving real stimulation, in this process, the position of the stimulation target is not changed, and the rest of the operation is the same.

Receive traditional medical therapy and sham stimulation

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead

Study Sites (1)

Sun Yat-sen Memorial Hospital

Guangzhou, Guangdong, 510120, China

RECRUITING

Related Publications (19)

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MeSH Terms

Conditions

Tinnitus; Hearing Loss, Sudden

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hearing Loss

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Yuexin Cai, Doctor

  Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuexin Cai, Doctor

CONTACT

+8613825063663; panada810456@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 16, 2023
• First Posted: July 28, 2023
• Study Start: November 23, 2023
• Primary Completion: August 30, 2024
• Study Completion: August 30, 2024
• Last Updated: November 27, 2023

Record last verified: 2023-11

Locations

CN (1)