Cohort Study on Biomarkers and Clinical Treatment of Tinnitus

Not Applicable

Recruiting

• Conditions: Transcranial Magnetic Stimulation, Repetitive; Tinnitus, Subjective; Acoustic Stimulation; Magnetoencephalography
• Interventions: Device: Acoustic stimulation; Device: Repetitive transcranial magnetic stimulation

• Registration Number: NCT05871294
• Lead Sponsor: Zhiwu Huang, Ph.D.

Brief Summary

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

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.

Study Timeline

• Study Start: 2023-02-01
• Study First Submitted: 2023-04-22
• Status Verified: 2023-05
• Study First Submitted QC: 2023-05-14
• Last Update Submitted: 2023-05-14
• Study First Posted: 2023-05-23
• Last Update Posted: 2023-05-23
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acoustic stimulation therapy	Acoustic stimulation	Patients in this group will receive acoustic stimulation therapy.
Repetitive transcranial magnetic stimulation therapy	Repetitive transcranial magnetic stimulation	Patients in this group will receive repetitive transcranial magnetic stimulation therapy.

Primary Outcome Measures

Name	Time	Method
THI	follow-up for 1 month after treatment completion	the scores of tinnitus handicap inventory（0-100）
VAS	follow-up for 1 month after treatment completion	Visual Analog Scale (VAS) is used to evaluate the loudness of tinnitus. The score range is 0-10

Trial Locations

Locations (1)

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University; 🇨🇳 Shanghai, Shanghai, China