Clinical trial NCT05871294: Cohort Study on Biomarkers and Clinical Treatment of Tinnitus
Official title: Cohort Study on Biomarkers and Clinical Treatment of Tinnitus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tinnitus, Subjective
Acoustic Stimulation
Transcranial Magnetic Stimulation, Repetitive
Magnetoencephalography
Lead sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Sponsor class: OTHER
First posted: 2023-05-23
Enrollment: 40
Sex: ALL
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: THI
timeFrame: Baseline
measure: THI
timeFrame: within 7 days of treatment completion
measure: THI
timeFrame: follow-up for 1 month after treatment completion
measure: VAS
timeFrame: Baseline
measure: VAS
timeFrame: within 7 days of treatment completion
measure: VAS
timeFrame: follow-up for 1 month after treatment completion
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
state: Shanghai
Study officials:
affiliation: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
name: Zhiwu Huang
role: PRINCIPAL_INVESTIGATOR
References: