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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
120
Patterned repetitive transcranial magnetic stimulation will be performed at specific frequencies and inter-train intervals
Low-frequency rTMS will be performed at a frequency of 1Hz
Eye & ENT Hospital of Fudan University
Shanghai, Shanghai Municipality, China
RECRUITINGTinnitus 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).
Time frame: 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).
Time frame: 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).
Time frame: 30 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).
Time frame: 5 days from baseline
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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).
Time frame: 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).
Time frame: 30 days from baseline
Minimum Masking Level (MML)
The MML assessment quantifies the minimum sound intensity required to mask the perception of tinnitus.
Time frame: 5 days from baseline
Minimum Masking Level (MML)
The MML assessment quantifies the minimum sound intensity required to mask the perception of tinnitus.
Time frame: 12 days from baseline
Minimum Masking Level (MML)
The MML assessment quantifies the minimum sound intensity required to mask the perception of tinnitus.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 30 days from baseline
Duration and intensity of residual inhibition (RI) for tinnitus
Used to measure the duration and intensity of RI for tinnitus.
Time frame: 5 days from baseline
Duration and intensity of residual inhibition (RI) for tinnitus
Used to measure the duration and intensity of RI for tinnitus.
Time frame: 12 days from baseline
Duration and intensity of residual inhibition (RI) for tinnitus
Used to measure the duration and intensity of RI for tinnitus.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 30 days from baseline