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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| frequency-specific rTMS | Device | Patterned repetitive transcranial magnetic stimulation will be performed at specific frequencies and inter-train intervals |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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). | 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). | 30 days from baseline |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 5 days from baseline |
| Visual Analogue Scale (VAS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shan Sun, PhD | Contact | +86-021-64377134-2033 | sunshine7896@126.com | |
| Dongmei Tang, PhD | Contact | +86-13023299189 | tang.dongm@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Huawei Li, PhD | Eye and ENT Hospital of Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eye & ENT Hospital of Fudan University | Recruiting | Shanghai | Shanghai Municipality | 200031 | China |
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| ID | Term |
|---|---|
| D014012 | Tinnitus |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
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| 1 Hz rTMS | Device | Low-frequency rTMS will be performed at a frequency of 1Hz |
|
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). |
| 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). | 30 days from baseline |
| Minimum Masking Level (MML) | The MML assessment quantifies the minimum sound intensity required to mask the perception of tinnitus. | 5 days from baseline |
| Minimum Masking Level (MML) | The MML assessment quantifies the minimum sound intensity required to mask the perception of tinnitus. | 12 days from baseline |
| Minimum Masking Level (MML) | The MML assessment quantifies the minimum sound intensity required to mask the perception of tinnitus. | 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. | 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. | 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. | 30 days from baseline |
| Duration and intensity of residual inhibition (RI) for tinnitus | Used to measure the duration and intensity of RI for tinnitus. | 5 days from baseline |
| Duration and intensity of residual inhibition (RI) for tinnitus | Used to measure the duration and intensity of RI for tinnitus. | 12 days from baseline |
| Duration and intensity of residual inhibition (RI) for tinnitus | Used to measure the duration and intensity of RI for tinnitus. | 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. | 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. | 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. | 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). | 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). | 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). | 30 days from baseline |
| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |