Tinnitus, SubjectiveNCT05871294
Cohort Study on Biomarkers and Clinical Treatment of Tinnitus
A study testing Acoustic stimulation and Repetitive transcranial magnetic stimulation in people with Tinnitus, Subjective and Acoustic Stimulation, run by Zhiwu Huang, Ph.D. at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages Up to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Tinnitus, Subjective, Acoustic Stimulation, Transcranial Magnetic Stimulation, Repetitive
- What is being tested?
- Acoustic stimulation and Repetitive transcranial magnetic stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2023to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, 200000
Zhiwu Huang, Professor, 18964331112, huangzw086@163.com
Qian Zhou
About this study
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.
Read the 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.
- Conditions
- Tinnitus, Subjective, Acoustic Stimulation, Transcranial Magnetic Stimulation, Repetitive, Magnetoencephalography
- Being tested
- Acoustic stimulation, Repetitive transcranial magnetic stimulation
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acoustic stimulationDevice
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 stimulationDevice
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)
| Study group | Role | What they receive |
|---|---|---|
| Acoustic stimulation therapy | Experimental | Patients in this group will receive acoustic stimulation therapy. Receives: Device: Acoustic stimulation |
| Repetitive transcranial magnetic stimulation therapy | Experimental | Patients in this group will receive repetitive transcranial magnetic stimulation therapy. Receives: Device: Repetitive transcranial magnetic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
THI
the scores of tinnitus handicap inventory（0-100）
Measured: Baseline
THI
the scores of tinnitus handicap inventory（0-100）
Measured: within 7 days of treatment completion
THI
the scores of tinnitus handicap inventory（0-100）
Measured: 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
Measured: Baseline
VAS
Visual Analog Scale (VAS) is used to evaluate the loudness of tinnitus. The score range is 0-10
Measured: 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
Measured: follow-up for 1 month after treatment completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2023
- Study start1 Feb 2023
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tinnitus, SubjectiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhiwu Huang, Ph.D.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhiwu Huang, Ph.D., Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
- Investigators
- Zhiwu Huang, Principal investigator, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05871294
- Sponsor's protocol ID
- SH9H-2022-T379-1
- Status last verified
- May 2023
- First submitted
- 22 Apr 2023
- Last updated
- 23 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cohort Study on Biomarkers and Clinical Treatment of Tinnitus
- ClinicalTrials.gov ID
- NCT05871294
- Acronym / sponsor ID
- SH9H-2022-T379-1
- Conditions
- Tinnitus, Subjective, Acoustic Stimulation, Transcranial Magnetic Stimulation, Repetitive, Magnetoencephalography
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Zhiwu Huang, Ph.D.University, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 23 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acoustic stimulation therapy | Experimental | Device: Acoustic stimulationPatients in this group will receive acoustic stimulation therapy. |
| Repetitive transcranial magnetic stimulation therapy | Experimental | Device: Repetitive transcranial magnetic stimulationPatients in this group will receive repetitive transcranial magnetic stimulation therapy. |
Who may qualify
- Ages
- Up to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acoustic stimulationThe 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. | Device | Acoustic stimulation therapy |
| Repetitive transcranial magnetic stimulationThe 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) | Device | Repetitive transcranial magnetic stimulation therapy |
Primary outcome
THI
Time frame: Baseline
the scores of tinnitus handicap inventory（0-100）
THI
Time frame: within 7 days of treatment completion
the scores of tinnitus handicap inventory（0-100）
THI
Time frame: follow-up for 1 month after treatment completion
the scores of tinnitus handicap inventory（0-100）
VAS
Time frame: Baseline
Visual Analog Scale (VAS) is used to evaluate the loudness of tinnitus. The score range is 0-10
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2023.
- Individual participant dataSharing planned: No
Related trials for Tinnitus, Subjective
Not yet recruitingPhase 1/2
Acute Nicotine Gum and Auditory Brain Responses in Adults With Chronic Tinnitus
Tinnitus, Chronic Subjective Tinnitus
Not yet recruiting
Advanced Neurofeedback for Tinnitus
Tinnitus, Subjective
Not yet recruiting
Efficacy Analysis of Transcutaneous Auricular Vagus Nerve Stimulation Combined With Tailor-Made Notched Music Therapy in the Treatment of Chronic Subjective Tinnitus
Chronic Subjective Tinnitus
Recruiting
Non-Invasive Neurofeedback Training to Alleviate Tinnitus Distress
Tinnitus Aggravated, Tinnitus
Not yet recruiting
COMPARISON OF MANUAL THERAPY, TINNITUS RETRAINING THERAPY
Somatosensory Tinnitus, Subjektif tınnitus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhiwu Huang principal investigator
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acoustic stimulation and Repetitive transcranial magnetic stimulation in people with Tinnitus, Subjective and Acoustic Stimulation, run by Zhiwu Huang, Ph.D. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhiwu Huang (18964331112, huangzw086@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
THI (time frame: Baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2023.