Cohort Study on Biomarkers and Clinical Treatment of Tinnitus

NCT ID: NCT05871294

Last Updated: 2023-05-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-01

Study Completion Date

2024-12-31

Brief Summary

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The goal of this clinical trial is to search for biomarkers in tinnitus patients in tinnitus patients and changes in biomarkers before and after treatment. The main questions it aims to answer are:

* What are the biomarkers of tinnitus patients?
* How do these biomarkers change during treatment and is there a good correlation with behavioral outcomes? Participants will be asked to complete audiological examination, tinnitus assessment, and magnetoencephalography examination, and they will receive sound therapy or repetitive transcranial magnetic stimulation therapy.

Detailed Description

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This study aims to use magnetoencephalography (MEG) to collect the resting state responses before and after treatment in the control group, tinnitus patients in the acoustic stimulation treatment group, and rTMS treatment group. Firstly, compare the differences in power spectrum and brain functional connectivity indicators between tinnitus patients and normal control groups in different frequency bands, providing a theoretical basis for clinical diagnosis, precise positioning of tinnitus damaged areas, and understanding the pathogenesis of tinnitus; Secondly, compare the electrophysiological functional indicators of tinnitus patients before and after treatment to reveal whether the damaged brain network can gradually reshape after treatment, and whether network information can serve as potential biomarkers to indicate the degree of tinnitus recovery; Finally, compare the effectiveness differences between the two treatment methods, analyze their influencing factors, and provide guidance for frequency band precise intervention and rehabilitation of chronic tinnitus patients.

Conditions

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Tinnitus, Subjective Acoustic Stimulation Transcranial Magnetic Stimulation, Repetitive Magnetoencephalography

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Acoustic stimulation therapy

Patients in this group will receive acoustic stimulation therapy.

Group Type EXPERIMENTAL

Acoustic stimulation

Intervention Type DEVICE

The sound used for treatment is selected based on the patient's tinnitus frequency and loudness. Patients receive 90 minutes of acoustic stimulation therapy every day (at least 5 days per week). The entire treatment period is 3 months.

Repetitive transcranial magnetic stimulation therapy

Patients in this group will receive repetitive transcranial magnetic stimulation therapy.

Group Type EXPERIMENTAL

Repetitive transcranial magnetic stimulation

Intervention Type DEVICE

The course of repeated transcranial magnetic stimulation therapy is 4 weeks, with 5, 5, 4, and 3 treatments per week, each lasting 90 minutes (including rest time)

Interventions

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Acoustic stimulation

The sound used for treatment is selected based on the patient's tinnitus frequency and loudness. Patients receive 90 minutes of acoustic stimulation therapy every day (at least 5 days per week). The entire treatment period is 3 months.

Intervention Type DEVICE

Repetitive transcranial magnetic stimulation

The course of repeated transcranial magnetic stimulation therapy is 4 weeks, with 5, 5, 4, and 3 treatments per week, each lasting 90 minutes (including rest time)

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Subjective tinnitus lasting for more than 6 months, with a score of\>36 of the Tinnitus Disability Inventory (THI);
2. The otoscopy examination showed that the ear canal and eardrum were normal, and the tympanic impedance maps of both ears were Type A, indicating that language ability met the requirements of language testing

Exclusion Criteria

1. Family or congenital deafness history, ototoxicity drug use history, otitis media patients, etc
2. Suffering from major physical diseases (sensory and motor disorders, neurological disorders, brain injuries, and other organic diseases) or mental disorders
3. The patient has aggressive behavior and an impulse to damage the device
4. Metal in the body (including orthodontics, dental implants), tattoos, and heart stent surgery
5. Having claustrophobia
6. Contraindications to magnetic resonance examination
Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Zhiwu Huang, Ph.D.

OTHER

Sponsor Role lead

Responsible Party

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Zhiwu Huang, Ph.D.

Professor, PHD, Director of the Hearing Center

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Zhiwu Huang

Role: PRINCIPAL_INVESTIGATOR

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Locations

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Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Zhiwu Huang

Role: CONTACT

18964331112

Facility Contacts

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Zhiwu Huang, Professor

Role: primary

18964331112

Other Identifiers

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SH9H-2022-T379-1

Identifier Type: -

Identifier Source: org_study_id

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