TinnitusNCT06635967
The Efficacy of Repetitive Transcranial Magnetic Stimulation in Patients With Chronic Subjective Tinnitus
A study testing frequency-specific rTMS and 1 Hz rTMS in people with Tinnitus, run by Eye & ENT Hospital of Fudan University at 1 site in China.
Trial summary
The aim of this study is to compare the efficacy of frequency-specific patterned repetitive transcranial magnetic stimulation (rTMS) and 1Hz rTMS for the treatment of chronic subjective tinnitus. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Tinnitus
- What is being tested?
- frequency-specific rTMS and 1 Hz rTMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 21 May 2024to 30 Dec 2025
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged between 18 and 80 years old.
- Experiencing persistant subjective tinnitus for at least 3 months.
- A score of 38 or more on THI.
- 50 dB HL or less on the average pure tone threshold (0.5, 1, 2kHz) of the worse ear.
- Voluntarily participate in the study and sign the informed consent form.
- Have normal mental status and cognitive function, and be able to cooperate with the research process.
Who cannot join
- Diagnosis of Meniere's disease, conductive hearing loss or objective tinnitus.
- History of epilepsy or stroke.
- Diagnosis of acoustic neuroma.
- Severe sensorineural hearing loss.
- Surgically or traumatically implanted ferromagnetic foreign bodies, including but not limited to pacemakers, neurostimulators, prosthetic metal heart valves, aneurysm clips (non-titanium alloy), intraocular metal foreign bodies, cochlear implants, metal prostheses, metal joints, fixed steel plates or steel pins.
- Patients with active metal foreign bodies (metal implants, dentures, contraceptive rings), insulin pumps, etc., who have been evaluated in detail and are at risk for rTMS treatment.
Show all 14Show fewer
- Patients taking vestibular sedatives, antipsychotics, anxiolytics, antiepileptics, and ototoxic drugs.
- Patients with a recent history of alcohol or drug abuse
- Bell's palsy
- Acute ear infection within the last 1 month
- Inability to cooperate or complete the study process
- Participation in another clinical trial within the last month.
- Have any condition that may affect compliance or safety
- Any other condition that, in the opinion of the investigator, makes enrollment in the study inappropriate.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Eye & ENT Hospital of Fudan University
Shanghai, Shanghai Municipality, 200031
Shan Sun, PhD, +86-021-64377134-2033, sunshine7896@126.com
About this study
The aim of this study is to compare the efficacy of frequency-specific patterned repetitive transcranial magnetic stimulation (rTMS) and 1Hz rTMS for the treatment of chronic subjective tinnitus. In this single-blind randomized controlled study, patients will be randomly assigned 1:1 to receive two different types of rTMS stimulation.
Read the detailed description
Tinnitus is a common disorder with a prevalence of 10-25% among adults, which seriously affects the quality of life of patients. Many studies have reported significant efficacy of repetitive transcranial magnetic stimulation (rTMS) for tinnitus, but its optimal stimulation parameters are not clear. Therefore, there is necessary to assess the clinical efficacy and mechanism of different types of rTMS for the treatment of chronic subjective tinnitus through rigorously designed clinical studies.
The study will assess the severity of tinnitus and the mood and sleep status of the patients through several scales and tinnitus psychoacoustic assessment before treatment, after treatment and at follow-up. The primary research hypothesis is that frequency-specific patterned rTMS will be superior to 1Hz rTMS in reducing tinnitus-related distress.
- Conditions
- Tinnitus
- Being tested
- frequency-specific rTMS, 1 Hz rTMS
- Keywords
- tinnitus, 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.
frequency-specific rTMSDevice
Patterned repetitive transcranial magnetic stimulation will be performed at specific frequencies and inter-train intervals
1 Hz rTMSDevice
Low-frequency rTMS will be performed at a frequency of 1Hz
| Study group | Role | What they receive |
|---|---|---|
| frequency-specific patterned rTMS | Experimental | Patients will receive a 5-day, once-daily frequency-specific patterned rTMS treatment via a circular coil applied to the auditory cortex. Each session will last 40 minutes and will be stimulated at an intensity of 80% resting motor threshold (RMT). Receives: Device: frequency-specific rTMS |
| 1 Hz rTMS | Active comparator | Patients will receive a 5-day, once-daily 1Hz rTMS treatment via a circular coil applied to the auditory cortex. Each session will last 40 minutes and will be stimulated at an intensity of 80% resting motor threshold (RMT). Receives: Device: 1 Hz rTMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tinnitus Handicap Inventory (THI)
The THI questionnaire, widely used in research, including functional, emotional, and catastrophic subscales. It consists of 25 questions, and answers are rated on a "yes" (4 points), "sometimes" (2 points), and "no" (0 points) scale. The total score is calculated by adding up the scores for all questions and classifying the severity of tinnitus as no handicap (0-16), mild handicap (18-36), moderate handicap (38-56), and severe handicap (58-100).
Measured: 5 days from baseline
Tinnitus Handicap Inventory (THI)
The THI questionnaire, widely used in research, including functional, emotional, and catastrophic subscales. It consists of 25 questions, and answers are rated on a "yes" (4 points), "sometimes" (2 points), and "no" (0 points) scale. The total score is calculated by adding up the scores for all questions and classifying the severity of tinnitus as no handicap (0-16), mild handicap (18-36), moderate handicap (38-56), and severe handicap (58-100).
Measured: 12 days from baseline
Tinnitus Handicap Inventory (THI)
The THI questionnaire, widely used in research, including functional, emotional, and catastrophic subscales. It consists of 25 questions, and answers are rated on a "yes" (4 points), "sometimes" (2 points), and "no" (0 points) scale. The total score is calculated by adding up the scores for all questions and classifying the severity of tinnitus as no handicap (0-16), mild handicap (18-36), moderate handicap (38-56), and severe handicap (58-100).
Measured: 30 days from baseline
Secondary outcomes (18)
Visual Analogue Scale (VAS)
Subjective perception of tinnitus loudness will be assessed using the VAS. Participants will be asked to rate the loudness of the tinnitus on a scale ranging from 0 (no tinnitus) to 10 (tinnitus could not be louder).
Measured: 5 days from baseline
Visual Analogue Scale (VAS)
Subjective perception of tinnitus loudness will be assessed using the VAS. Participants will be asked to rate the loudness of the tinnitus on a scale ranging from 0 (no tinnitus) to 10 (tinnitus could not be louder).
Measured: 12 days from baseline
Visual Analogue Scale (VAS)
Subjective perception of tinnitus loudness will be assessed using the VAS. Participants will be asked to rate the loudness of the tinnitus on a scale ranging from 0 (no tinnitus) to 10 (tinnitus could not be louder).
Measured: 30 days from baseline
Minimum Masking Level (MML)
The MML assessment quantifies the minimum sound intensity required to mask the perception of tinnitus.
Measured: 5 days from baseline
Minimum Masking Level (MML)
The MML assessment quantifies the minimum sound intensity required to mask the perception of tinnitus.
Measured: 12 days from baseline
Minimum Masking Level (MML)
The MML assessment quantifies the minimum sound intensity required to mask the perception of tinnitus.
Measured: 30 days from baseline
Tinnitus Loudness Matching (LM)
Used to measure tinnitus loudness. The level of intensity of an external sound that the patient perceives as equivalent to their tinnitus is used as the LM measurement.
Measured: 5 days from baseline
Tinnitus Loudness Matching (LM)
Used to measure tinnitus loudness. The level of intensity of an external sound that the patient perceives as equivalent to their tinnitus is used as the LM measurement.
Measured: 12 days from baseline
Tinnitus Loudness Matching (LM)
Used to measure tinnitus loudness. The level of intensity of an external sound that the patient perceives as equivalent to their tinnitus is used as the LM measurement.
Measured: 30 days from baseline
Duration and intensity of residual inhibition (RI) for tinnitus
Used to measure the duration and intensity of RI for tinnitus.
Measured: 5 days from baseline
Duration and intensity of residual inhibition (RI) for tinnitus
Used to measure the duration and intensity of RI for tinnitus.
Measured: 12 days from baseline
Duration and intensity of residual inhibition (RI) for tinnitus
Used to measure the duration and intensity of RI for tinnitus.
Measured: 30 days from baseline
Self-rating Anxiety Scale (SAS)
The SAS is a concise, validated tool for assessing anxiety levels in research and clinical settings. It comprises 20 items rated on a 4-point scale, summing to a total score indicating anxiety severity.
Measured: 5 days from baseline
Self-rating Anxiety Scale (SAS)
The SAS is a concise, validated tool for assessing anxiety levels in research and clinical settings. It comprises 20 items rated on a 4-point scale, summing to a total score indicating anxiety severity.
Measured: 12 days from baseline
Self-rating Anxiety Scale (SAS)
The SAS is a concise, validated tool for assessing anxiety levels in research and clinical settings. It comprises 20 items rated on a 4-point scale, summing to a total score indicating anxiety severity.
Measured: 30 days from baseline
Athens Insomnia Scale (AIS)
The AIS comprises eight items that commonly measure difficulties in falling asleep or maintaining sleep to quantify the presence of insomnia. The higher the AIS score, the lower the sleep quality and mental status. The AIS identifies three types of sleep disorders: no insomnia (score below 4), suspicious (4-6), and insomnia (score between 7-24).
Measured: 5 days from baseline
Athens Insomnia Scale (AIS)
The AIS comprises eight items that commonly measure difficulties in falling asleep or maintaining sleep to quantify the presence of insomnia. The higher the AIS score, the lower the sleep quality and mental status. The AIS identifies three types of sleep disorders: no insomnia (score below 4), suspicious (4-6), and insomnia (score between 7-24).
Measured: 12 days from baseline
Athens Insomnia Scale (AIS)
The AIS comprises eight items that commonly measure difficulties in falling asleep or maintaining sleep to quantify the presence of insomnia. The higher the AIS score, the lower the sleep quality and mental status. The AIS identifies three types of sleep disorders: no insomnia (score below 4), suspicious (4-6), and insomnia (score between 7-24).
Measured: 30 days from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2024
- Study start21 May 2024
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TinnitusStudies of the same condition, open and under way.
- More trials run by Eye & ENT Hospital of Fudan UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eye & ENT Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Huawei Li, PhD, Principal investigator, Eye & ENT Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06635967
- Sponsor's protocol ID
- 2024098
- Status last verified
- Aug 2024
- First submitted
- 9 Oct 2024
- Last updated
- 10 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Repetitive Transcranial Magnetic Stimulation in Patients With Chronic Subjective Tinnitus
- ClinicalTrials.gov ID
- NCT06635967
- Acronym / sponsor ID
- 2024098
- Conditions
- Tinnitus
- Keywords
- tinnitus, repetitive transcranial magnetic stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Eye & ENT Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 21 May 2024 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 10 Oct 2024 (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 aim of this study is to compare the efficacy of frequency-specific patterned repetitive transcranial magnetic stimulation (rTMS) and 1Hz rTMS for the treatment of chronic subjective tinnitus. In this single-blind randomized controlled study, patients will be randomly assigned 1:1 to receive two different types of rTMS stimulation.
Detailed description
Tinnitus is a common disorder with a prevalence of 10-25% among adults, which seriously affects the quality of life of patients. Many studies have reported significant efficacy of repetitive transcranial magnetic stimulation (rTMS) for tinnitus, but its optimal stimulation parameters are not clear. Therefore, there is necessary to assess the clinical efficacy and mechanism of different types of rTMS for the treatment of chronic subjective tinnitus through rigorously designed clinical studies.
The study will assess the severity of tinnitus and the mood and sleep status of the patients through several scales and tinnitus psychoacoustic assessment before treatment, after treatment and at follow-up. The primary research hypothesis is that frequency-specific patterned rTMS will be superior to 1Hz rTMS in reducing tinnitus-related distress.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| frequency-specific patterned rTMS | Experimental | Device: frequency-specific rTMSPatients will receive a 5-day, once-daily frequency-specific patterned rTMS treatment via a circular coil applied to the auditory cortex. Each session will last 40 minutes and will be stimulated at an intensity of 80% resting motor threshold (RMT). |
| 1 Hz rTMS | Active comparator | Device: 1 Hz rTMSPatients will receive a 5-day, once-daily 1Hz rTMS treatment via a circular coil applied to the auditory cortex. Each session will last 40 minutes and will be stimulated at an intensity of 80% resting motor threshold (RMT). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults aged between 18 and 80 years old.
- Experiencing persistant subjective tinnitus for at least 3 months.
- A score of 38 or more on THI.
- 50 dB HL or less on the average pure tone threshold (0.5, 1, 2kHz) of the worse ear.
- Voluntarily participate in the study and sign the informed consent form.
Key exclusion criteria (14 listed)
- Diagnosis of Meniere's disease, conductive hearing loss or objective tinnitus.
- History of epilepsy or stroke.
- Diagnosis of acoustic neuroma.
- Severe sensorineural hearing loss.
- Surgically or traumatically implanted ferromagnetic foreign bodies, including but not limited to pacemakers, neurostimulators, prosthetic metal heart valves, aneurysm clips (non-titanium alloy), intraocular metal foreign bodies, cochlear implants, metal prostheses, metal joints, fixed steel plates or steel pins.
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 |
|---|---|---|
| frequency-specific rTMSPatterned repetitive transcranial magnetic stimulation will be performed at specific frequencies and inter-train intervals | Device | frequency-specific patterned rTMS |
| 1 Hz rTMSLow-frequency rTMS will be performed at a frequency of 1Hz | Device | 1 Hz rTMS |
Primary outcome
Tinnitus Handicap Inventory (THI)
Time frame: 5 days from baseline
The THI questionnaire, widely used in research, including functional, emotional, and catastrophic subscales. It consists of 25 questions, and answers are rated on a "yes" (4 points), "sometimes" (2 points), and "no" (0 points) scale. The total score is calculated by adding up the scores for all questions and classifying the severity of tinnitus as no handicap (0-16), mild handicap (18-36), moderate handicap (38-56), and severe handicap (58-100).
Tinnitus Handicap Inventory (THI)
Time frame: 12 days from baseline
The THI questionnaire, widely used in research, including functional, emotional, and catastrophic subscales. It consists of 25 questions, and answers are rated on a "yes" (4 points), "sometimes" (2 points), and "no" (0 points) scale. The total score is calculated by adding up the scores for all questions and classifying the severity of tinnitus as no handicap (0-16), mild handicap (18-36), moderate handicap (38-56), and severe handicap (58-100).
Tinnitus Handicap Inventory (THI)
Time frame: 30 days from baseline
The THI questionnaire, widely used in research, including functional, emotional, and catastrophic subscales. It consists of 25 questions, and answers are rated on a "yes" (4 points), "sometimes" (2 points), and "no" (0 points) scale. The total score is calculated by adding up the scores for all questions and classifying the severity of tinnitus as no handicap (0-16), mild handicap (18-36), moderate handicap (38-56), and severe handicap (58-100).
18 secondary outcomes
Visual Analogue Scale (VAS)
Time frame: 5 days from baseline
Visual Analogue Scale (VAS)
Time frame: 12 days from baseline
Visual Analogue Scale (VAS)
Time frame: 30 days from baseline
Minimum Masking Level (MML)
Time frame: 5 days from baseline
Minimum Masking Level (MML)
Time frame: 12 days from baseline
Minimum Masking Level (MML)
Time frame: 30 days from baseline
Tinnitus Loudness Matching (LM)
Time frame: 5 days from baseline
Tinnitus Loudness Matching (LM)
Time frame: 12 days from baseline
Tinnitus Loudness Matching (LM)
Time frame: 30 days from baseline
Duration and intensity of residual inhibition (RI) for tinnitus
Time frame: 5 days from baseline
Duration and intensity of residual inhibition (RI) for tinnitus
Time frame: 12 days from baseline
Duration and intensity of residual inhibition (RI) for tinnitus
Time frame: 30 days from baseline
Self-rating Anxiety Scale (SAS)
Time frame: 5 days from baseline
Self-rating Anxiety Scale (SAS)
Time frame: 12 days from baseline
Self-rating Anxiety Scale (SAS)
Time frame: 30 days from baseline
Athens Insomnia Scale (AIS)
Time frame: 5 days from baseline
Athens Insomnia Scale (AIS)
Time frame: 12 days from baseline
Athens Insomnia Scale (AIS)
Time frame: 30 days from baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2024.
Related trials for Tinnitus
Not yet recruitingPhase 1/2
Acute Nicotine Gum and Auditory Brain Responses in Adults With Chronic Tinnitus
Tinnitus, Chronic Subjective Tinnitus
RecruitingPhase 2
A Study of the Safety and Efficacy of TRTL-913 in Healthy Volunteers (Part A) and in Adults With Tinnitus (Part B)
Tinnitus
RecruitingObservational study
Lemborexant vs Clonidine vs Sedatives to Treat Insomnia in Chronic Pain Patients
Chronic Insomnia, Chronic Pain
Not yet recruiting
Effect of a Totally Implantable Cochlear Implant on Tinnitus Severity in Adults With Preoperative Tinnitus
Sensorineural Hearing Loss, Tinnitus
Enrolling by invitationObservational study
Comparing an AI-driven Hearing Test With the Standard Hearing Test in Adults With Hearing Loss and Tinnitus
Sensorineural Hearing Loss, Tinnitus
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.
Huawei Li, PhD principal investigator
Eye & ENT Hospital of Fudan 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 frequency-specific rTMS and 1 Hz rTMS in people with Tinnitus, run by Eye & ENT Hospital of Fudan University 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 6 inclusion and 14 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 10 Oct 2024. 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 Shan Sun, PhD (+86-021-64377134-2033, sunshine7896@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tinnitus Handicap Inventory (THI) (time frame: 5 days from baseline). The study lists 3 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 10 Oct 2024.