Cohort Study on Biomarkers and Clinical Treatment of Tinnitus

Tinnitus, Subjective Clinical Trial

Official title:

Cohort Study on Biomarkers and Clinical Treatment of Tinnitus

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05871294
• Other study ID #: SH9H-2022-T379-1
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2023
• Est. completion date: December 2024

Study information

• Verified date: May 2023
• Source: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
• Contact: Zhiwu Huang
• Phone: 18964331112
• Email: huangzw086[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 65 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.
• 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)

Locations

Country	Name	City	State
China	Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Zhiwu Huang, Ph.D.

Country where clinical trial is conducted

China, 

Outcome

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