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Cohort Study on Biomarkers and Clinical Treatment of Tinnitus

Primary Purpose

Tinnitus, Subjective, Acoustic Stimulation, Transcranial Magnetic Stimulation, Repetitive

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Acoustic stimulation
Repetitive transcranial magnetic stimulation
Sponsored by
Zhiwu Huang, Ph.D.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tinnitus, Subjective

Eligibility Criteria

undefined - 65 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Subjective tinnitus lasting for more than 6 months, with a score of>36 of the Tinnitus Disability Inventory (THI); 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: Family or congenital deafness history, ototoxicity drug use history, otitis media patients, etc Suffering from major physical diseases (sensory and motor disorders, neurological disorders, brain injuries, and other organic diseases) or mental disorders The patient has aggressive behavior and an impulse to damage the device Metal in the body (including orthodontics, dental implants), tattoos, and heart stent surgery Having claustrophobia Contraindications to magnetic resonance examination

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Acoustic stimulation therapy

Repetitive transcranial magnetic stimulation therapy

Arm Description

Patients in this group will receive acoustic stimulation therapy.

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

Outcomes

Primary Outcome Measures

THI
the scores of tinnitus handicap inventory(0-100)
THI
the scores of tinnitus handicap inventory(0-100)
THI
the scores of tinnitus handicap inventory(0-100)
VAS
Visual Analog Scale (VAS) is used to evaluate the loudness of tinnitus. The score range is 0-10
VAS
Visual Analog Scale (VAS) is used to evaluate the loudness of tinnitus. The score range is 0-10
VAS
Visual Analog Scale (VAS) is used to evaluate the loudness of tinnitus. The score range is 0-10

Secondary Outcome Measures

Full Information

First Posted
April 22, 2023
Last Updated
May 14, 2023
Sponsor
Zhiwu Huang, Ph.D.
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1. Study Identification

Unique Protocol Identification Number
NCT05871294
Brief Title
Cohort Study on Biomarkers and Clinical Treatment of Tinnitus
Official Title
Cohort Study on Biomarkers and Clinical Treatment of Tinnitus
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2023 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Zhiwu Huang, Ph.D.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinnitus, Subjective, Acoustic Stimulation, Transcranial Magnetic Stimulation, Repetitive, Magnetoencephalography

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Acoustic stimulation therapy
Arm Type
Experimental
Arm Description
Patients in this group will receive acoustic stimulation therapy.
Arm Title
Repetitive transcranial magnetic stimulation therapy
Arm Type
Experimental
Arm Description
Patients in this group will receive repetitive transcranial magnetic stimulation therapy.
Intervention Type
Device
Intervention Name(s)
Acoustic stimulation
Intervention Description
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
Intervention Name(s)
Repetitive transcranial magnetic stimulation
Intervention Description
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)
Primary Outcome Measure Information:
Title
THI
Description
the scores of tinnitus handicap inventory(0-100)
Time Frame
Baseline
Title
THI
Description
the scores of tinnitus handicap inventory(0-100)
Time Frame
within 7 days of treatment completion
Title
THI
Description
the scores of tinnitus handicap inventory(0-100)
Time Frame
follow-up for 1 month after treatment completion
Title
VAS
Description
Visual Analog Scale (VAS) is used to evaluate the loudness of tinnitus. The score range is 0-10
Time Frame
Baseline
Title
VAS
Description
Visual Analog Scale (VAS) is used to evaluate the loudness of tinnitus. The score range is 0-10
Time Frame
within 7 days of treatment completion
Title
VAS
Description
Visual Analog Scale (VAS) is used to evaluate the loudness of tinnitus. The score range is 0-10
Time Frame
follow-up for 1 month after treatment completion

10. Eligibility

Sex
All
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Subjective tinnitus lasting for more than 6 months, with a score of>36 of the Tinnitus Disability Inventory (THI); 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: Family or congenital deafness history, ototoxicity drug use history, otitis media patients, etc Suffering from major physical diseases (sensory and motor disorders, neurological disorders, brain injuries, and other organic diseases) or mental disorders The patient has aggressive behavior and an impulse to damage the device Metal in the body (including orthodontics, dental implants), tattoos, and heart stent surgery Having claustrophobia Contraindications to magnetic resonance examination
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhiwu Huang
Phone
18964331112
Email
huangzw086@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhiwu Huang
Organizational Affiliation
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhiwu Huang, Professor
Phone
18964331112
Email
huangzw086@163.com
First Name & Middle Initial & Last Name & Degree
Qian Zhou

12. IPD Sharing Statement

Plan to Share IPD
No

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Cohort Study on Biomarkers and Clinical Treatment of Tinnitus

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