Cohort Study on Biomarkers and Clinical Treatment of Tinnitus

Last updated: May 14, 2023
Sponsor: Zhiwu Huang, Ph.D.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Auditory Stimulation

Tinnitus

Treatment

Acoustic stimulation

Repetitive transcranial magnetic stimulation

Clinical Study ID

NCT05871294
SH9H-2022-T379-1
  • Ages < 65
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

  1. Family or congenital deafness history, ototoxicity drug use history, otitis mediapatients, etc
  2. Suffering from major physical diseases (sensory and motor disorders, neurologicaldisorders, 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 stentsurgery
  5. Having claustrophobia
  6. Contraindications to magnetic resonance examination

Study Design

Total Participants: 40
Treatment Group(s): 2
Primary Treatment: Acoustic stimulation
Phase:
Study Start date:
February 01, 2023
Estimated Completion Date:
December 31, 2024

Study 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.

Connect with a study center

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

    Shanghai, Shanghai 200000
    China

    Active - Recruiting

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