Cohort Study on Biomarkers and Clinical Treatment of Tinnitus

NCT05871294 | Unknown

• 1 other identifier: SH9H-2022-T379-1
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (6)

• THI

  the scores of tinnitus handicap inventory（0-100）

  Baseline

• THI

  the scores of tinnitus handicap inventory（0-100）

  within 7 days of treatment completion

• THI

  the scores of tinnitus handicap inventory（0-100）

  follow-up for 1 month after treatment completion

• VAS

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

  Baseline

• 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

• 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

Study Arms (2)

Acoustic stimulation therapy

EXPERIMENTAL

Patients in this group will receive acoustic stimulation therapy.

Device: Acoustic stimulation

Repetitive transcranial magnetic stimulation therapy

EXPERIMENTAL

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

Device: Repetitive transcranial magnetic stimulation

Interventions

Acoustic stimulation DEVICE

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.

Acoustic stimulation therapy

Repetitive transcranial magnetic stimulation DEVICE

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)

Repetitive transcranial magnetic stimulation therapy

Eligibility Criteria

• Age: Up to 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zhiwu Huang, Ph.D.: lead

Study Sites (1)

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

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

MeSH Terms

Conditions

Tinnitus

Interventions

Acoustic Stimulation; Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Sensory Art Therapies; Complementary Therapies; Physical Stimulation; Investigative Techniques; Magnetic Field Therapy

Study Officials

• Zhiwu Huang

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhiwu Huang

CONTACT

18964331112; huangzw086@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, PHD, Director of the Hearing Center

Study Record Dates

• First Submitted: April 22, 2023
• First Posted: May 23, 2023
• Study Start: February 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: May 23, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)