Cohort Study on Biomarkers and Clinical Treatment of Tinnitus

May 14, 2023 updated by: Zhiwu Huang, Ph.D.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200000
        • Recruiting
        • Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
        • Contact:
        • Sub-Investigator:
          • Qian Zhou

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Acoustic stimulation therapy
Patients in this group will receive acoustic stimulation therapy.
Device: 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.
Experimental: Repetitive transcranial magnetic stimulation therapy
Patients in this group will receive repetitive transcranial magnetic stimulation therapy.
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
THI
Time Frame: Baseline
the scores of tinnitus handicap inventory（0-100）
Baseline
THI
Time Frame: within 7 days of treatment completion
the scores of tinnitus handicap inventory（0-100）
within 7 days of treatment completion
THI
Time Frame: follow-up for 1 month after treatment completion
the scores of tinnitus handicap inventory（0-100）
follow-up for 1 month after treatment completion
VAS
Time Frame: Baseline
Visual Analog Scale (VAS) is used to evaluate the loudness of tinnitus. The score range is 0-10
Baseline
VAS
Time Frame: within 7 days of treatment completion
Visual Analog Scale (VAS) is used to evaluate the loudness of tinnitus. The score range is 0-10
within 7 days of treatment completion
VAS
Time Frame: 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
follow-up for 1 month after treatment completion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhiwu Huang, Ph.D.

Investigators

  • Principal Investigator: Zhiwu Huang, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2023

Primary Completion (Anticipated)

December 1, 2024

Study Completion (Anticipated)

December 1, 2024

Study Registration Dates

First Submitted

April 22, 2023

First Submitted That Met QC Criteria

May 14, 2023

First Posted (Actual)

May 23, 2023

Study Record Updates

Last Update Posted (Actual)

May 23, 2023

Last Update Submitted That Met QC Criteria

May 14, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SH9H-2022-T379-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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